Fibromyalgia Trial, Completed NCT03497585 Sponsor: Pennine Acute Hospitals NHS Trust Condition: Fibromyalgia
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Trial 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

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.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Fibromyalgia Trial, Completed

NCT03497585
Completed Not Applicable

Who may be able to join

AI generated eligibility 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

Who might be able to join this trial:

  • You have been referred by your GP or a hospital specialist to The Pennine Acute Hospitals NHS Trust with a diagnosis of chronic low back pain, chronic widespread pain, fibromyalgia, or Chronic Fatigue Syndrome/ME, and your symptoms have lasted for at least 3 months.
  • You have been referred to a rehabilitation programme for chronic pain or fatigue.
  • You are 18 years old or older.
  • You are able to read and write in English.

For the interview part of the study, the following also apply:

  • You attended at least one session of the rehabilitation programme, agreed to take part in the study, and completed the first questionnaire booklet (you do not need to have finished the full programme to take part in the interviews).
  • Healthcare professionals (such as physiotherapists or psychological wellbeing practitioners) who deliver the rehabilitation programmes and have been trained in the activity pacing framework may also be eligible to take part in the interview part of the study.

Who may not be able to join:

  • You have a serious underlying health condition, such as a current diagnosis of cancer.
  • You have significant mental health difficulties or problems with memory and thinking that may affect your ability to take part.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Trial details

Status
Completed
Phase
Not Applicable
Sponsor
Pennine Acute Hospitals NHS Trust
Registry
ClinicalTrials.gov
Start date
21 May 2018
Est. completion
31 December 2019

Where this trial is recruiting

🇬🇧 United Kingdom

Primary endpoints

Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov