Reported trial results for Fibromyalgia
Every Fibromyalgia trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.
35 trials have reported results.
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
-
NCT04115033 · results posted 27 February 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04115033) looked at a treatment called Cranial Electrotherapy Stimulation (CES) — a device that delivers a very mild electrical current to the head — in people with fibromyalgia, a condition involving widespread pain. A total of 48 people were enrolled: 25 in the group using the real CES device and 23 in a "sham" (inactive/pretend device) group for comparison. Of those, 17 in the real-device group and 16 in the sham group completed the study. The trial measured pain scores, physical function, brain connectivity patterns on scans, and self-reported fatigue, depression, and anxiety — all tracked from the start of the trial to 6 and 12 weeks later. The reported data shows that for the primary measure — pain scored on a 0–10 scale (where 0 is no pain and 10 is the worst pain) — both groups reported lower scores compared to where they started. At 12 weeks, the real-device group's average score had dropped by 1.38 points from their starting point, while the sham group's average score had dropped by 2.00 points. For the physical function tests, both groups reported being able to do more sit-to-stands and bicep curls at 12 weeks than at the start, with changes of a similar size across groups; handgrip strength changes were small and mixed across both groups. For the brain scan connectivity measure, the reported numbers showed differences between groups, but the researchers noted that further research is needed to understand what those differences actually mean. For the self-reported measures of fatigue, depression, and anxiety (scored on a standardised scale where 50 is the population average), both groups reported small reductions — that is, modest improvements — across all three areas, with the size of the changes varying between the two groups depending on which measure was looked at. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02589275 · results posted 11 December 2024
According to the results reported on ClinicalTrials.gov, this trial involved 375 people across two groups. One group (177 people) had previously received the active treatment, TNX-102 SL, in an earlier study and continued on it here — referred to as the TNX-TNX group. The other group (198 people) had previously received a placebo and then switched to the active treatment in this open-label extension study — referred to as the PBO-TNX group. An open-label extension means all participants knew they were receiving the active treatment. The study tracked whether participants experienced any new adverse events (unexpected or unwanted health occurrences) after starting their first dose of TNX-102 SL in this extension phase. The reported data shows that the primary outcome measured was the number of participants who had at least one newly occurring adverse event after beginning the treatment in this study. In the TNX-TNX group, 77 out of 177 participants (those who had been on the treatment previously) had at least one such event reported. In the PBO-TNX group, 132 out of 198 participants (those newly switched to the active treatment) had at least one such event reported. No secondary outcome measure data appears to have been submitted in the structured results provided, so those figures are not available to report here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT04059042 · results posted 15 December 2023
According to the results reported on ClinicalTrials.gov, this trial involved 10 people in total — 5 in a "Music" group and 5 in a "Nature Sounds" group. Nine participants completed the study (4 in the Music group and 5 in the Nature Sounds group), with one person in the Music group not finishing. The trial was measuring two things related to how people experience pain: "pain threshold summation" (roughly, how much worse pain feels when a stimulus is repeated 10 times in a row compared to just once) and "pain tolerance" (the amount of physical pressure at which a person rates their pain at 70 out of 100 on a pain scale). The reported data shows the following numbers for pain threshold summation, measured on a 0–100 scale where higher numbers mean more severe summation. The Music group recorded scores of 20.25 and 20.17 across two sets of measurements, while the Nature Sounds group recorded scores of 4.13 and 9.40. For pain tolerance, measured in kilograms of pressure per square centimetre, the Music group recorded 4.12 and 4.18 across two sets of measurements, while the Nature Sounds group recorded 5.17 and 5.05. The reported data does not include further detail explaining the two sets of measurements for each group, so what distinguishes them cannot be described here. It is worth noting that with only 10 participants in total, this was a very small study, and the raw numbers above are simply what was recorded and submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT05005351 · results posted 1 August 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT05005351) involved 67 people with fibromyalgia, split into two groups. Thirty-nine participants were assigned to a digital program based on Acceptance and Commitment Therapy (ACT) — a type of structured psychological approach delivered online — and 28 were assigned to a digital symptom tracker. The trial was measuring how fibromyalgia severity and participants' own sense of change compared between the two groups over 12 weeks. Almost all participants who started the trial completed it (37 out of 39 in the ACT group, and 27 out of 28 in the tracker group). The reported data shows that both groups saw a reduction in their fibromyalgia impact scores over the course of the trial, as measured by a questionnaire called the Revised Fibromyalgia Impact Questionnaire (FIQ-R), where a lower score indicates lower reported severity. The ACT group's average score dropped by 8.7 points, while the symptom tracker group's average score dropped by 3.0 points. For the second key measure — participants' own global impression of whether they had improved at week 12 — the reported data shows that 27 out of 37 participants in the ACT group reported some level of improvement, compared with 6 out of 27 in the symptom tracker group. These numbers describe what was observed and recorded in this particular group of trial participants. The reported data shows differences between the two groups, but what those differences mean in a broader sense is a matter for clinical interpretation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01693692 · results posted 4 March 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 392 people across three groups: one group received a placebo (a dummy treatment with no active ingredient), and two groups received different amounts of a drug called TD-9855. The trial was measuring how fibromyalgia — a condition causing widespread pain — responded across several measures, including daily pain levels, overall impact on daily life, and participants' own sense of whether their condition had changed. The reported data shows that the primary measure was the percentage change in pain scores, rated on a scale from 0 (no pain) to 10 (worst possible pain). The placebo group's pain score changed by minus 0.9%, while the TD-9855 Group 1 changed by minus 1.2%, and TD-9855 Group 2 changed by minus 1.4%. For the secondary measure of overall fibromyalgia impact (scored 0–100, where lower means less impact), the placebo group scored 44.0, Group 1 scored 42.4, and Group 2 scored 38.2 at the end of the study. For participants' own impression of change (scored 1–7, where 1 means "very much improved" and 7 means "very much worse"), the placebo group averaged 3.2, Group 1 averaged 2.9, and Group 2 averaged 2.8. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03056690 · results posted 3 March 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03056690) enrolled 186 people in total — 95 in the placebo group (a dummy treatment with no active ingredient) and 91 in the ASP0819 15 mg group. The trial was measuring changes in daily pain levels over 8 weeks using a standard 0–10 pain rating scale (where 0 means no pain and 10 means the worst pain imaginable), as well as tracking unwanted health events and monitoring for any thoughts or behaviours related to suicide throughout the study period. The reported data shows that, on average, participants in the placebo group rated their pain 1.26 points lower at Week 8 compared to where they started, while participants in the ASP0819 15 mg group rated their pain 1.60 points lower on the same scale — both representing a reduction from their starting scores. Regarding unwanted health events (also called adverse events — any health problem that started or got worse after the first dose), 53 out of 94 treated placebo participants and 62 out of 90 treated ASP0819 participants reported at least one such event. No participants in either group reported any serious adverse events in the categories recorded. For the suicide-related assessments carried out at Weeks 2, 4, 8, and 10, the reported data shows that no participants in either group reported suicidal thoughts or behaviours at any of those time points, with the exception of one participant in the placebo group who reported suicidal ideation at Week 10. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03497585 · results posted 17 December 2020
According to the results reported on ClinicalTrials.gov, this trial tested an "Activity Pacing Framework" — a structured programme designed to help people with chronic pain or fatigue learn strategies for managing their daily activities across five areas: adjusting activities, keeping activities consistent, planning activities, accepting limitations, and progressing activities gradually. A total of 112 people started the trial, 57 completed it, and 55 did not complete it. There was only one group in this trial, meaning everyone received the same programme; there was no comparison group. The main thing the trial was measuring was whether participants' scores on a specially designed questionnaire (the APQ-28, scored 0–4 for each of the five activity areas, where higher means more use of pacing strategies) changed over the six-week programme. The reported data shows that across the five activity areas, scores at the start of the programme ranged from about 1.49 to 1.91 out of 4. By the end of the six weeks, those scores ranged from about 2.39 to 2.65. The reported changes (the primary outcome) ranged from approximately 0.67 to 0.99 points across the five areas. At a three-month follow-up check, scores ranged from about 2.00 to 2.42 — somewhat lower than at the end of treatment but higher than at the start. The trial also measured pain using an 11-point scale (0 = no pain, 10 = worst possible pain). The reported data shows that at the start, current pain averaged 6.71 and usual pain averaged 7.47. At the end of the six-week programme, current pain averaged 5.31 and usual pain averaged 6.62. No further pain data beyond the end of treatment was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02187159 · results posted 9 November 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,270 people across four groups to study treatments for fibromyalgia — a condition involving widespread pain and fatigue. Participants were randomly assigned to receive either a placebo (a dummy treatment with no active ingredient), pregabalin 150 mg twice daily, DS-5565 15 mg once daily, or DS-5565 15 mg twice daily. The main thing being measured was how much each person's daily pain score changed over 13 weeks, rated on a scale from 0 (no pain) to 10 (worst possible pain). Between 221 and 249 people in each group completed the full 13 weeks. The reported data shows that all four groups had lower average daily pain scores by week 13 compared to where they started. The placebo group's average score fell by 1.86 points, the pregabalin group's fell by 2.47 points, the DS-5565 once-daily group's fell by 2.24 points, and the DS-5565 twice-daily group's fell by 2.09 points. For the secondary measures — which looked at overall wellbeing, fatigue, anxiety, depression, and how participants rated their own overall change — all groups also reported lower (improved) scores by week 13. For example, when asked to rate their overall impression of change, 91 people in the placebo group, 141 in the pregabalin group, 116 in the DS-5565 once-daily group, and 117 in the DS-5565 twice-daily group said they felt "much improved or better." Similar patterns of change across all groups were reported for fatigue, anxiety, and depression scores. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03008837 · results posted 27 July 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03008837) enrolled 21 people with fibromyalgia — 12 in a group receiving a treatment called PENFS (a type of nerve stimulation applied to the ear) and 9 receiving standard therapy. By the end of the study, 9 people in the PENFS group and 5 in the standard therapy group had completed it. The trial was measuring whether a brain-scanning technique called functional connectivity MRI (fcMRI — a scan that looks at how different parts of the brain communicate with each other) could detect changes in brain activity related to pain, and also whether pain scores and physical function changed over 2, 6, and 12 weeks of follow-up. The reported data shows that for the main (primary) outcome — changes in brain connectivity in a network linked to pain — the PENFS group showed no detectable change in the specific brain regions being tracked, while the standard therapy group showed one cluster of 61 voxels (a "voxel" is simply a tiny unit of space in a brain scan image). For the pain score secondary outcome, both groups reported lower pain scores at all three follow-up points compared to their starting levels; for example, at 12 weeks the PENFS group's average score had dropped by 1.3 points and the standard therapy group's by 0.1 points (on a 0–10 scale). The reported data also shows that scores for how much pain interfered with daily activity, sleep, mood, and stress generally moved in different directions between the two groups across the follow-up period, though the size of these changes was modest in both cases. For the physical tests, the reported data shows that at each follow-up point, people in the PENFS group performed more additional bicep curls (both arms) and sit-to-stand movements compared to their starting numbers than people in the standard therapy group did — for instance, at 6 weeks the PENFS group averaged 6 more left-arm curls than at baseline, while the standard therapy group averaged 1.8 fewer. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02234583 · results posted 23 July 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 2,088 participants in total — 847 in a once-daily dose group and 1,241 in a twice-daily dose group — of whom 434 and 685 respectively completed the study. The trial was testing a medicine called DS-5565 (taken either once or twice a day) and was measuring things like daily pain levels, sleep disruption, mood, and overall quality of life over 52 weeks (about one year). Participants were split into two broad categories: "rollover" participants who had been in an earlier related study, and "de novo" participants who were new to the trial. The reported data shows that for the main measure — a daily pain score rated from 0 (no pain) to 10 (worst possible pain) — participants in all four groups started with scores ranging from roughly 4.8 to 7.4 at baseline, and by Week 52 those scores ranged from approximately 3.0 to 4.2. For a secondary measure asking participants to rate their overall impression of change, the reported data shows that 208, 333, 96, and 92 participants (across the four groups respectively) rated themselves as "much improved or better" at Week 52. On a questionnaire measuring anxiety and depression (scored 0–21, with higher meaning worse), scores at Week 52 ranged from about 4.4 to 6.3 for depression and 5.1 to 5.7 for anxiety across groups. Sleep interference scores (0–10 scale) at Week 52 ranged from roughly 2.3 to 3.2 across the four groups, compared to starting scores of 3.8 to 6.8. The reported data also shows scores from two broader quality-of-life questionnaires. On the EQ-5D overall health scale (0–100, higher is better), end-of-study scores ranged from 0.70 to 0.81 across groups, up from starting scores of 0.61 to 0.70. On the SF-36 physical health summary (0–100, higher meaning less disability), Week 52 scores ranged from about 39 to 46, compared to starting scores of roughly 32 to 38; mental health summary scores at Week 52 ranged from approximately 47.5 to 50.1. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03825393 · results posted 7 April 2020
According to the results reported on ClinicalTrials.gov, this study involved 200 people in total — 100 people diagnosed with fibromyalgia and 100 people without the condition who served as a comparison (control) group. All 200 participants completed the study with no dropouts reported. The study was measuring sleep quality, iron storage levels in the blood (ferritin), and the impact of fibromyalgia on daily life, mood, and anxiety in people with fibromyalgia compared to those without it. The reported data shows that people in the fibromyalgia group had an average score of 8.3 on the Pittsburgh Sleep Quality Index — a questionnaire where a score of 5 or above is considered "poor" sleep (the scale runs from 1 to 9). For ferritin (a marker of iron stored in the body, measured in ng/ml), the fibromyalgia group averaged 20.95 ng/ml compared to 34.91 ng/ml in the control group. On the Fibromyalgia Impact Questionnaire — a 0–100 scale where higher numbers indicate a greater effect on day-to-day functioning — the fibromyalgia group averaged 61.69. The reported data also shows an average Beck Depression Inventory score of 15.73 for the fibromyalgia group (on a 0–63 scale, this range is described as "slight depression"), and an average Beck Anxiety Inventory score of 22.58 (on a 0–63 scale, this range is described as "moderate to severe anxiety"). Scores for the control group on these questionnaires were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01797263 · results posted 24 February 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 256 adults with fibromyalgia — 129 assigned to a yoga programme and 127 assigned to a structured exercise programme. The trial was measuring the overall impact of fibromyalgia on participants' lives, using a questionnaire called the Fibromyalgia Impact Questionnaire Revised (FIQR). The main measurement point was at three months, with further check-ins at six and nine months to see whether any changes lasted. By the end of the study, 92 people in the yoga group and 87 in the structured exercise group had completed it. The reported data shows that at the primary three-month endpoint, the yoga group scored an average of 41.5 out of 90 on the overall FIQR questionnaire, while the structured exercise group scored 42.2 out of 90 — where a higher number indicates a worse outcome. For the secondary measures, the reported data shows similarly close results between the two groups across all areas tested: a "difficulty" subscale (yoga: 10.8, exercise: 10.5, out of 20); an "overall impact" subscale (yoga: 7.3, exercise: 7.9, out of 100); and a "symptoms" subscale (yoga: 23.5, exercise: 23.8, out of 100). Pain severity, measured on a separate tool scored out of 40, was reported as 5.6 for the yoga group and 5.9 for the structured exercise group. A depression questionnaire scored out of 27 returned averages of 8.6 for the yoga group and 9.8 for the structured exercise group. It is worth noting that the results submitted to ClinicalTrials.gov appear to report a single set of scores for each group without specifying which time point those figures relate to — so it is not possible from this data alone to describe how scores may have changed from the start of the trial to the end. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03619889 · results posted 24 October 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 74 people in total — 37 in a "sham simulation" group (a dummy/inactive version of the treatment, used as a comparison) and 37 in a "Manual Pressure Release Technique" group (a hands-on physical therapy approach targeting muscle trigger points). Two participants in the sham group did not complete the study, while everyone in the treatment group finished. The trial was measuring changes in pain levels, jaw opening, neck disability, and several psychological measures across three time points: before treatment, immediately after treatment, and three months later. The reported data shows that for the main outcome — perceived pain rated on a 0–10 scale (where 0 means no pain) — the Manual Pressure Release Technique group reported average reductions of 2.30 points immediately after treatment and 2.84 points at three months, compared with reductions of 1.03 and 0.77 points in the sham group at those same time points. The researchers noted that a change of at least 1.2 points on this scale was considered the minimum meaningful difference. For the secondary outcomes, the reported data shows changes across both groups in measures of jaw-muscle pressure sensitivity, mouth opening range (measured in millimetres), neck disability, fear of movement (kinesiophobia), and catastrophising (a measure of how distressing someone finds their pain) — with varying numerical changes across the three time points for each group. Some of these figures moved in different directions between the two groups, but the full breakdown of what drove those differences was not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00932360 · results posted 10 January 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT00932360) enrolled 43 participants in total across six groups, each receiving the three study conditions — active TENS (a device that sends mild electrical pulses through the skin), placebo TENS (a sham version of the device), and no treatment — in a different order. There was a one-week "washout" break between each condition to allow any effects to fade before the next one began. Two participants dropped out during the first washout period, so 41 people completed all three stages. The trial was measuring changes in pain and fatigue, both at rest and during movement, before and after each condition. The reported data shows that for pain at rest, the difference scores (where a positive number means pain went up and a negative number means it went down, on a 0–10 scale) were +0.38 for active TENS, –0.74 for placebo TENS, and –0.47 for no treatment. For pain with movement, the reported scores varied depending on the order participants received the treatments, with values of +1.11, +0.23, and +0.26 across the three sequence groups. For fatigue at rest, the reported difference scores were –0.09 (active TENS), –0.14 (placebo TENS), and +0.12 (no treatment). For fatigue with movement, the scores were +0.94, +0.39, and +0.04 respectively. The trial also measured pressure pain thresholds — essentially how much physical pressure a person could tolerate before feeling pain — at the neck and lower back. The reported data shows the neck threshold scores were 53.15 kPa for active TENS, 26.42 kPa for placebo TENS, and 19.39 kPa for no treatment; lower back scores were 86.97 kPa, 34.89 kPa, and 33.23 kPa respectively. No further breakdown of these figures was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00447083 · results posted 13 November 2018
According to the results reported on ClinicalTrials.gov, this trial looked at whether exposure to UVB light (a type of ultraviolet light) had any effect on pain, compared to a non-UVB exposure used as a comparison. The trial ran in two phases. In Phase I, 19 people took part (10 in one group, 9 in another), and all 19 completed that phase. In Phase II, 16 people took part (8 in each group), and 14 of those 16 completed the phase — one person from each group did not finish. The trial measured pain using an 11-point scale, where 0 meant no pain and 10 meant the worst possible pain. The reported data shows the following numbers. In Phase I, the primary measure looked at what percentage of light exposures led to a meaningful drop in pain (defined as a 2-point improvement on the pain scale): 33% of UVB exposures were recorded as meeting that threshold, compared to 16% of non-UVB exposures. For post-treatment pain scores in Phase I (a secondary measure), the UVB group recorded an average score of 4.89 and the non-UVB group recorded 5.21. In Phase II, the primary measure was the average pain score: the UVB group recorded 4.55 and the non-UVB group recorded 4.95. A secondary pain score measure in Phase II showed 4.65 for the UVB group and 5.54 for the non-UVB group. No other outcome data was reported beyond these figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03039088 · results posted 19 September 2018
According to the results reported on ClinicalTrials.gov, this trial involved 508 people in total — 192 who had been identified as having fibromyalgia, and 316 who had not. All participants completed the study with no drop-outs recorded. The trial was looking at whether having fibromyalgia affected how people responded to a type of medication called TNF alpha blockers (a group of treatments used in certain inflammatory conditions). Response to treatment was measured using something called the BASDAI50 — this is a scoring tool where a 50% improvement in a patient's symptom score is counted as a positive response. The reported data shows that, at the 12-week mark, 87 out of 192 participants in the fibromyalgia group recorded a BASDAI50 response, compared with 171 out of 316 participants in the group without fibromyalgia. The trial also listed four secondary outcome measures — including things like the percentage of patients with fibromyalgia and how well real-world prescribing matched official guidelines — however, no numerical results were reported on ClinicalTrials.gov for any of these secondary measures, so those figures are not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01981096 · results posted 10 September 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 40 young people with fibromyalgia, split into two groups of 20. One group received a programme called Fibromyalgia Integrative Training, and the other received Cognitive Behavioral Therapy (a talking-based approach to managing thoughts and feelings). The trial measured three things: average pain intensity over the past week, how much difficulty participants had with everyday physical and social activities (called functional disability), and depressive symptoms. By the end of the study, 17 participants in the Fibromyalgia Integrative Training group and 19 in the Cognitive Behavioral Therapy group had completed the trial. The reported data shows that for pain intensity — scored on a scale from 0 (no pain) to 10 (worst possible pain) — both groups started at similar levels (around 6.3 and 6.4 respectively). At the end of treatment, the Fibromyalgia Integrative Training group's average score was reported as 4.69, while the Cognitive Behavioral Therapy group's average score was 6.38. At a later follow-up point, those figures were reported as 4.62 and 6.55 respectively. For functional disability — scored from 0 to 60, where lower means fewer difficulties — the Fibromyalgia Integrative Training group started at 26.70 and was reported at 18.71 at the end of treatment and 19.76 at follow-up, while the Cognitive Behavioral Therapy group started at 24.45 and was reported at 23.95 and then 22.68. For depressive symptoms — scored from 0 to 54, where lower means fewer symptoms — the Fibromyalgia Integrative Training group started at 15.8 and was reported at 11.71 at the end of treatment and 11.35 at follow-up, compared with the Cognitive Behavioral Therapy group starting at 14.05 and finishing at 13.79 and then 12.95. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00523302 · results posted 11 July 2018
According to the results reported on ClinicalTrials.gov, this trial involved 20 people with fibromyalgia, split evenly into two groups of 10. One group received active Transcranial Magnetic Stimulation (TMS — a non-invasive procedure that uses magnetic pulses directed at the brain), and the other received a "sham" version, meaning it mimicked the procedure without delivering real stimulation. All 20 participants completed the study. The trial was measuring three things across multiple time points: average pain levels, the overall impact of fibromyalgia on daily functioning, and symptoms of depression. The reported data shows the following for average pain (scored 0–10, where 10 is extreme pain): the active TMS group's scores across the five measurement time points were 5.60, 4.90, 3.99, 4.19, and 4.41, while the sham group's scores were 5.43, 5.49, 5.07, 4.76, and 5.37. For the Fibromyalgia Impact Questionnaire (scored 0–80, where higher means greater impact on life), the active TMS group recorded 58.79, 55.03, 42.07, 49.29, and 38.99, compared to the sham group's 54.38, 51.22, 51.50, 43.47, and 47.93. For the depression scale (scored 0–52, where higher means more severe depression), the active TMS group recorded 21.80, 17.30, 16.10, 15.80, and 14.10, while the sham group recorded 17.60, 17.40, 15.30, 17.20, and 16.40 across the same time points. No information about statistical analysis or the spacing of those time points was included in the reported data. It is worth noting that with only 10 people in each group, this was a very small study, and the results as submitted do not include any formal comparison between the two groups. The reported data shows the raw scores for each group at each time point only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02500628 · results posted 3 January 2018
According to the results reported on ClinicalTrials.gov, this trial involved two groups of participants: 38 people with fibromyalgia and 23 people who were taking antipsychotic medication. All 61 participants completed the study — none dropped out. The trial was measuring how a single dose of metformin (a medication commonly used for diabetes) affected the heart's rhythm patterns, specifically something called heart rate variability. This refers to the tiny natural changes in the time between heartbeats, which can reflect how the body's nervous system is functioning. Measurements were taken before and about two hours after taking the metformin. The reported data shows that for the fibromyalgia group, the ratio of heartbeat-interval variation before versus after taking metformin was 0.92, while for the antipsychotic use group it was 0.83. A ratio of 1.0 would mean no change between the two time points, so both numbers sit close to but below that mark. For the second way of measuring heart rhythm patterns (using frequency-based analysis, which looks at rhythmic waves in the heartbeat data), the reported log-transformed ratios were −0.14 for the fibromyalgia group and −0.24 for the antipsychotic use group. These figures simply reflect the mathematical relationship between the before and after measurements in each group. The reported data also shows that participants were asked after testing to mention any side effects they noticed from the medication — without being prompted with a list. In the fibromyalgia group, 13 out of 38 participants reported at least one side effect, while in the antipsychotic use group, 9 out of 23 did. No further detail about the nature of those side effects was included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02015234 · results posted 7 July 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02015234) involved people with fibromyalgia and looked at a medication called TNX-102 SL (a tablet placed under the tongue at bedtime). A total of 158 people took part — 79 in a group that started on a placebo (a dummy tablet) before switching to TNX-102 SL, and 79 who took TNX-102 SL throughout. Of those, 43 and 54 people respectively completed the full study period. The trial's main focus was on tracking newly emerging unwanted events (side effects or health changes noticed after starting treatment) over 12 months, and it also measured changes in participants' self-reported pain scores and their overall sense of whether their condition had changed. The reported data shows that, for the primary measure — newly-emerged unwanted health events — 60 people in the placebo-first group and 54 in the TNX-102 SL group reported such events; 18 and 9 people respectively experienced serious unwanted events; and 3 and 5 people respectively had a further category of events (the data labels for these sub-categories were not fully detailed in the submission). For pain scores, participants rated their pain on a scale of 0 (no pain) to 10 (worst pain imaginable). The reported data shows starting average pain scores of around 5.6 and 5.0 for the two groups, with small changes from those starting points recorded at various time points — for example, changes ranging from around −0.2 to −0.8 in some periods, and close to 0 in others. The full breakdown across all time points is available in the ClinicalTrials.gov record. For the secondary measure asking participants to rate their overall impression of change, the reported data shows that at one time point 16 people in the placebo-first group and 25 in the TNX-102 SL group rated themselves as "very much improved" or "much improved" (the definition of a "responder" in this study), while at other time points those numbers were 22–23 and 26–29 respectively, out of the participants assessed at each stage. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02052414 · results posted 9 October 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 34 participants, all of whom received a medication called Gralise (an extended-release form of gabapentin). The trial was measuring how fibromyalgia affected participants over approximately 15 weeks — including their pain levels, sleep, and overall wellbeing — using several standard questionnaires and rating scales. Of the 34 people who started the trial, 17 completed it, and 17 did not complete it. The reported data shows the following numbers across five visits (baseline, then roughly every 4 weeks during treatment, and a final check 3 weeks after treatment ended). For pain, participants rated their pain on a 0–10 scale (where 0 means no pain and 10 means the worst pain imaginable): scores were reported as 7.29 at the start, then 4.72, 3.95, and 3.83 during treatment, rising to 6.94 at the post-treatment visit. For sleep, the reported average hours slept per night were 5.86 at the start, then 7.17, 6.81, and 7.04 during treatment, falling to 6.23 at the final visit. For the Fibromyalgia Impact Questionnaire — a 0–100 scale where higher numbers mean greater impact on daily life — scores were reported as 71.04 at the start, dropping to 41.82, 40.79, and 39.27 during treatment, then rising to 61.86 at the post-treatment visit. The reported data also shows that varying numbers of participants reported side effects at each visit (ranging from 1 to 8 participants at any given visit), though the specific nature of those side effects was not described in detail in the submitted data. An additional measure called the Patient Global Impression of Change — a 7-point scale where 1 means "very much improved" and 7 means "very much worse" — was also reported across four visits, with average scores of 4.96, 5.40, 5.37, and 4.44. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01108731 · results posted 15 October 2014
According to the results reported on ClinicalTrials.gov, this trial involved 34 people in total — 17 who took a drug called milnacipran and 17 who took a placebo (a dummy treatment with no active ingredient). Of those, 13 in each group completed the trial, and 4 in each group did not finish. The trial was measuring three things: levels of a chemical called lactate in the brain (using a brain scanning technique), how quickly and accurately people responded in a computer-based attention test, and how much widespread pain people reported on a scale of 0 to 10. The reported data shows that, for brain lactate levels, the milnacipran group had an average change of −0.87 international units (meaning levels went down on average), while the placebo group had an average change of +0.32 (meaning levels went up slightly on average). For the attention test's "no cue" reaction time — where lower numbers mean faster responses — the milnacipran group's average change was −79.56 milliseconds and the placebo group's was −35.00 milliseconds; for the related "executive attention" part of the same test, the changes were −68.73 milliseconds and −34.77 milliseconds respectively. For widespread pain (on the 0–10 scale), the milnacipran group reported an average change of −1.24 (a reduction), while the placebo group reported an average change of +0.66 (a small increase). It is worth noting that the data as submitted does not include information about whether these differences between groups were considered statistically meaningful (that is, unlikely to have occurred by chance), so those figures cannot be interpreted further here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00928720 · results posted 13 August 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT00928720) enrolled 57 people in total across three groups: 19 received an active CES (cranial electrotherapy stimulation) device, 20 received a sham (inactive) version of the same device, and 18 received usual care alone. By the end of the study, 17, 14, and 15 participants respectively had completed the trial. The trial was measuring pain intensity as its main focus, along with several other things including fatigue, sleep disturbance, depression, perceived stress, and overall functioning — all commonly affected in conditions like fibromyalgia. The reported data shows the following scores at the end of the study. For pain (measured on a 0–10 scale, where 10 is the worst pain imaginable), the CES device group scored 5.12, the sham device group scored 6.36, and the usual care group scored 6.62. For fatigue (also 0–10), the reported scores were 4.97, 6.38, and 6.83 respectively. For sleep disturbance, the scores were 2.79, 6.38 — wait, to correct that — 2.79, 3.86, and 3.53. For depression (using a standard questionnaire scale), the scores were 16.5, 28.63, and 23.42. For perceived stress (0–10 scale), the scores were 3.93, 5.64, and 5.29. Finally, for overall functioning using the Fibromyalgia Impact Questionnaire, the scores were 45.05, 70.1, and 63.2 — where higher numbers on this scale indicate greater impact on daily functioning. It is worth noting that these are group average scores reported at a single point in time, and the trial was relatively small in size. No information about whether the differences between groups were statistically meaningful (that is, unlikely to be due to chance) was included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00115804 · results posted 15 February 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 6 participants, all of whom received the medication fluoxetine. Four participants completed the study, while 2 did not finish. The trial was measuring pain severity and a range of other outcomes in children, including how much their daily activities were affected, their mood, and how they and their clinicians rated their overall condition and any improvement over time. The reported data shows that on the main measure — average pain severity, rated on a scale from 0 (no pain) to 100 (severe pain) — participants scored 62 mm on average. For the secondary measures, a clinician-rated scale of illness severity (ranging from 1, meaning not ill at all, to 7, meaning extremely ill) returned an average score of 5. On a scale where patients rated their own sense of improvement since the start of the study (1 meaning very much better, 7 meaning very much worse), the average reported score was 1.5. The children's self-reported difficulty with daily activities (scored 0 to 60, with higher meaning more difficulty) averaged 24.2, while parents rating the same thing averaged 19.2. A measure of depressive symptoms in children (scored 0 to 54, with higher meaning more symptoms) returned an average score of 14.2. It is worth noting that only 6 people took part in this trial, which is a very small number, and the results data on ClinicalTrials.gov does not include separate before-and-after figures for most measures, only the scores recorded. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00830167 · results posted 1 June 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 498 people — 248 in a placebo (dummy treatment) group and 250 in a pregabalin group. The trial was measuring pain levels in participants, using an 11-point scale where 0 means no pain and 10 means the worst possible pain. It also tracked how participants felt their overall condition had changed, and looked at several aspects of sleep quality, including sleep disturbance, snoring, waking up short of breath or with a headache, and the total amount of sleep each night. The reported data shows that, for the main pain measure, the placebo group's average pain score dropped by 1.03 points from their starting score, while the pregabalin group's average pain score dropped by 1.48 points. For the question about how participants felt their overall condition had changed, 62.1% of people in the placebo group rated themselves as at least "minimally improved," compared with 70.0% in the pregabalin group. Regarding sleep, the reported data shows that scores for sleep disturbance fell by 8.13 points in the placebo group and by 17.62 points in the pregabalin group (where a bigger drop means less disturbance). For waking up short of breath or with a headache, scores fell by 3.02 points in the placebo group and 8.01 points in the pregabalin group. The snoring score fell slightly in the placebo group (by 1.61 points) but increased slightly in the pregabalin group (by 3.37 points). The reported quantity of sleep increased by a small amount in both groups — 0.17 units for placebo and 0.46 units for pregabalin. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00830128 · results posted 14 February 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 106 participants, all of whom received the study medicine pregabalin. By the end of the study, 87 participants had completed it, while 19 did not finish. The trial was primarily focused on tracking any unwanted medical events (called adverse events) that occurred during treatment, including serious ones — such as events leading to hospitalisation, life-threatening situations, or death. Secondary measurements looked at changes in self-reported pain levels and several aspects of sleep quality. The reported data shows that, out of 106 participants, 102 experienced at least one treatment-emergent adverse event (meaning an unwanted medical occurrence that appeared or got worse after starting the study medicine), and 3 participants experienced a serious adverse event as defined above. For pain, participants rated their pain on a scale of 0 (no pain) to 100 (worst possible pain); the reported data shows an average change of −13.1 mm from the start of the study to the endpoint, meaning scores were lower on average at the end. For sleep, several subscales were measured using a questionnaire scored from 0 to 100. The reported data shows average changes of −9.6 points for sleep disturbance (where a lower score means less disturbance), +4.2 points for sleep adequacy (where a higher score means feeling more rested), +1.9 points for snoring, and −3.0 points for waking short of breath or with a headache. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01077375 · results posted 26 January 2012
According to the results reported on ClinicalTrials.gov, this trial (NCT01077375) involved 107 participants in total — 21 in the placebo group and 86 in the milnacipran group. The trial was measuring two main things: first, how many participants reported feeling "very much improved" or "much improved" on a simple self-rated scale called the Patient Global Impression of Change (PGIC) at week 13; and second, how much participants' pain scores changed over the same period, using a pain scale running from 0 (no pain) to 100 (worst possible pain). Not everyone finished the trial — 11 out of 21 placebo participants and 51 out of 86 milnacipran participants completed it. The reported data shows that, at week 13, 5 out of 21 participants in the placebo group and 26 out of 86 participants in the milnacipran group rated themselves as "very much improved" or "much improved" on the PGIC scale. For the pain score, the reported data shows that the placebo group's average pain score changed by −1.3 points from the start of the trial (a very small decrease), while the milnacipran group's average pain score changed by −12.3 points (a larger decrease). These are the numbers as submitted — the trial does not report what happened to participants who did not complete the study, so those figures are not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00087555 · results posted 10 January 2012
According to the results reported on ClinicalTrials.gov, this trial looked at a medication called sodium oxybate (brand name Xyrem) in people with fibromyalgia — a condition involving widespread pain and other symptoms. A total of 195 people started the trial and were split into three groups: one group received a placebo (a dummy treatment with no active ingredient), one received a 4.5g dose of Xyrem, and one received a 6.0g dose. The trial ran for 8 weeks and was measuring whether participants improved across three self-reported areas: their pain level, their overall fibromyalgia impact on daily life, and their own sense of how much better or worse they felt overall. The reported data shows that the main result was the percentage of people in each group who showed at least a 20% improvement in both their pain score and their fibromyalgia impact score, *and* who also reported feeling "much better" or "very much better" overall. According to the results reported on ClinicalTrials.gov, approximately 12.9% of people in the placebo group met all three of those criteria at the same time. In the 4.5g Xyrem group, that figure was reported as 29.8%, and in the 6.0g Xyrem group it was 28.1%. The data also shows the flip side — roughly 87.1% of the placebo group, 70.2% of the 4.5g group, and 71.9% of the 6.0g group did *not* meet all three criteria together. It is worth noting that not everyone who started the trial completed it — 12 people in the placebo group, 11 in the 4.5g group, and 21 in the 6.0g group did not finish. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00423605 · results posted 20 October 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 560 people, all of whom received Xyrem (sodium oxybate) at doses ranging from 4.5 grams to 9.0 grams. Of those who started the trial, 319 people completed it, while 241 did not finish. The trial was set up to track and record any unwanted or unexpected health events (called adverse events) that participants experienced while taking the medication. The reported data shows that the only outcome measure recorded was the number of participants who reported at least one adverse event during the study. According to the results reported on ClinicalTrials.gov, 498 out of 560 participants reported experiencing at least one adverse event. No other outcome data — such as details about what those events were, their severity, or any measures of how well the treatment performed against a condition — were included in the submitted results data. It is worth noting that this trial had only one reported outcome measure, which focused entirely on recording adverse events rather than comparing the treatment against a placebo or measuring symptom improvement. No secondary outcome data was reported in the submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00793520 · results posted 1 July 2010
According to the results reported on ClinicalTrials.gov, this trial (NCT00793520) was a crossover study, meaning participants were assigned to receive either the medication milnacipran followed by a placebo, or a placebo followed by milnacipran. The trial was measuring two things: firstly, whether the amount of pressure needed to cause a medium level of pain changed over the course of treatment (the primary measure); and secondly, whether a pain-processing response in the body — known as Diffuse Noxious Inhibitory Control, or DNIC, which is essentially the body's natural ability to dampen pain signals — changed over the course of treatment (the secondary measure). Only 2 participants appear to have been enrolled across the two groups, with 1 person in each group. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for either the primary outcome (change in pressure pain threshold, measured in kilograms) or the secondary outcome (change in the DNIC pain response, measured on a pain rating scale). Additionally, the reported data shows that neither of the 2 participants completed the trial — both are listed as "not completed." Because no measurement data was reported, it is not possible to describe any findings for either outcome. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00696787 · results posted 23 February 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 125 adults across three groups: 40 people received a placebo (a dummy treatment with no active ingredient), 42 received a medicine called DVS SR, and 43 received a medicine called pregabalin. The trial was measuring changes in self-reported pain levels in people with fibromyalgia, using an 11-point scale called the Numeric Rating Scale (NRS), where 0 means no pain and 10 means the worst possible pain. Not everyone finished the trial — 25 people in the placebo group, 22 in the DVS SR group, and 17 in the pregabalin group completed it. The reported data shows how much each group's average pain score changed from the start of the trial to week 8 (a negative number means the score went down, i.e. lower reported pain). For the primary measure covering all participants, the placebo group's score dropped by an average of 1.98 points, the DVS SR group's score dropped by 1.60 points, and the pregabalin group's score dropped by 1.70 points. A secondary measure looked specifically at adult female outpatients and reported similar figures: the placebo group dropped by 2.00 points, DVS SR by 1.64 points, and pregabalin by 1.45 points. No other outcome figures were included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00464737 · results posted 5 January 2010
According to the results reported on ClinicalTrials.gov, this trial looked at whether a skin-patch medication called rotigotine (tested at two doses — 4 mg and 8 mg) had any effect on pain and other symptoms in people with fibromyalgia, compared to a placebo (an inactive patch). A total of 230 people took part: 82 in the placebo group, 74 in the rotigotine 4 mg group, and 74 in the rotigotine 8 mg group. The trial ran for 12 weeks. Not everyone completed the study — 50 placebo participants, 42 in the 4 mg group, and only 19 in the 8 mg group finished the full treatment period. The reported data shows that the main thing being measured was the change in average daily pain, rated on a scale from 0 (no pain) to 10 (worst pain ever). By the end of the 12 weeks, the placebo group's average pain score had dropped by 1.12 points, the rotigotine 4 mg group's dropped by 1.27 points, and the rotigotine 8 mg group's dropped by 0.83 points. The trial also measured several other things. On the Fibromyalgia Impact Questionnaire (a 0–100 scale where higher scores mean fibromyalgia is affecting life more), scores fell by 14.9 points in the placebo group, 13.4 in the 4 mg group, and 12.8 in the 8 mg group. For sleep quality (0–10, where higher means worse sleep), scores dropped by 0.95, 0.82, and 0.48 points respectively. For how much pain interfered with daily activity (0–10 scale), the drops were 1.11, 1.19, and 0.88 points. No measurements were reported for the Total Myalgic Score outcome, so that data was not available. The trial also asked participants to rate their overall change in pain on a 7-point scale (from "much worse" to "much better"), though the full breakdown of those responses across all categories was not straightforward to interpret from the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00689052 · results posted 25 November 2009
According to the results reported on ClinicalTrials.gov, this trial (NCT00689052) enrolled 61 people in total — 31 were given a placebo (a dummy treatment with no active ingredient) and 30 were given a medicine called pramipexole. The trial was designed to look at fibromyalgia, and it set out to measure several things: how much participants' daily pain levels changed (rated on a scale of 0–10, where 0 means no pain and 10 means the worst possible pain), how participants felt their overall condition had improved, and how the condition affected their physical functioning, quality of life, anxiety, and depression. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — neither the primary pain score measure nor any of the six secondary measures (including the Patient's Global Impression of Improvement, the SF-36 physical functioning survey, pain improvement thresholds, the Fibromyalgia Impact Questionnaire, or the Hospital Anxiety and Depression Scale). The participant completion data also shows zero participants recorded as having completed the study, which may suggest the trial did not finish as planned, though no further explanation was provided in the submitted data. Because no measurement results were reported, it is not possible to describe what the trial found about any of the outcomes it set out to assess. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00552578 · results posted 7 July 2009
According to the results reported on ClinicalTrials.gov, this trial involved 12 people in total — six in a group that received gradually reducing (tapering) doses of buprenorphine, and six in a group that received a steady, unchanged dose of buprenorphine. The trial was looking at whether participants returned to substance use, how many stayed on their assigned dosing plan all the way through, and how participants felt their overall quality of life had changed after six months. One person from each group did not finish the study. The reported data shows that, when it came to returning to substance use — measured either by what participants reported themselves or by urine tests — 2 out of 6 participants in the tapering dose group and 4 out of 6 in the steady dose group were recorded as having relapsed. For treatment retention — meaning completing the full dosing plan as assigned — the reported numbers show that 0 out of 6 participants in the tapering dose group completed their plan, while 5 out of 6 in the steady dose group completed theirs. Regarding quality of life, the reported data shows that 4 participants in each group said they felt their overall quality of life was better at six months compared to when they started. It is worth noting that this was a very small trial with only six people in each group, which means the numbers should be interpreted with great caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00333866 · results posted 13 May 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 747 adults across four groups: a placebo group and three groups receiving different daily doses of pregabalin (300 mg, 450 mg, or 600 mg). The trial was measuring two main things: how much participants' pain scores changed over up to 14 weeks, and how participants rated their overall condition compared to the start of the trial. Pain and sleep quality were each tracked using an 11-point scale, where 0 meant no pain or best possible sleep, and 10 meant the worst possible pain or sleep. The reported data shows that on the pain scale, all four groups recorded a reduction in their average pain score from the start of the trial. The placebo group's score dropped by 0.73 points, the 300 mg group by 1.06 points, the 450 mg group by 1.29 points, and the 600 mg group by 0.96 points. For the second primary measure — participants' own ratings of how their overall condition had changed — the reported data shows that across the groups, between 7 and 20 participants said they were "very much improved," and between 43 and 50 said they were "much improved," with further numbers rating themselves as "minimally improved." For sleep quality (a secondary measure), all groups also showed reductions in their sleep problem scores, with the placebo group dropping by 0.94 points and the three pregabalin groups dropping by 1.42, 1.72, and 1.95 points respectively at the endpoint. Not all participants completed the trial — completion numbers ranged from 121 to 141 across the four groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
See the full Fibromyalgia page · What changed recently
Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.