Study for people with Osteoarthritis
Not yet recruiting Not a phased study
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Royal North Shore Hospital | Sydney | NSW | Status not stated |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Inclusion Criteria:
1. Male or female at least 40years of age
2. Knee OA with Kellgren-Lawrence (KL) Grade 2 to 4 of the target knee on X-ray
3. Inadequate pain relief with 1st line treatment, consisting of any of the following
1. conservative non-pharmacological treatment AND/OR
2. stable dose NSAIDs for at least the past 30 days OR
3. use of NSAID treatment is contraindicated
4. Target knee pain on most days (at least 15 days per month in the preceding month)
5. Symptomatic knee OA with moderate to severe pain (NRS ≥4 and \<9 on Numeric Rating Scale (NRS) with target knee significantly worse than the other knee with a minimum difference of 2-point between knees.
6. Possess cognitive and language ability to complete informed consent and questionnaires
7. Willingness to follow protocol instructions and maintain appointment schedule of the study
8. Willingness to maintain their existing stable regimen (defined as the same regimen for at least the past 30 days) of complementary and non-pharmacological knee OA treatments for trial duration (if any)
9. If participant is taking a stable regimen of NSAIDs - they are willing to maintain their existing stable regimen (defined as taking the same dose for at least the past 30 days) of NSAIDs and not anticipate to change for the duration of the study.
10. Willingness to stop any 'as needed' (PRN) NSAIDs or paracetamol or opioids (except for protocol-permitted rescue pain medication) for the duration of the trial
11. Willingness to stop taking any rescue pain meds 24 hours prior to scheduled follow up clinic visits (except for their stable NSAIDs therapy)
Exclusion Criteria:
1. Pregnant or lactating
2. Other significant knee pathologies of target knee from medical history or radiographic method(s)
3. Severe malalignment \> 10 degree in the target knee (either varus or valgus) measured using standardized knee x-ray at screening or based on previous medical records
4. Severe inflammatory arthritis or other joint disease with warm, red, and swollen knee in the target knee
5. History of knee surgery or significant knee trauma of target knee in the past 12 months
6. Received intraarticular injection in the targeted knee joint within the past 6 months
7. Knee surgery or intraarticular injection in the target knee planned in the next 8 months
8. Allergy to rescue pain medication (paracetamol)
9. Unstable/ poorly controlled coagulopathy\[CH1.1\]\[LC1.2\]
10. Severe anxiety, depression or psychiatric disorder based on self -reported medical history
11. Chronic pain conditions other than knee OA (e.g. cancer, fibromyalgia, pain due to hip OA, etc.) which may interfere with the outcomes of the study, at the discretion of the investigator
12. History of or current substance abuse, self-reported
13. Significant systemic medical comorbidities, e.g. uncontrolled diabetes or hypertension, immunocompromised, cancer, severe cardiovascular disease, neuropathic pain/disorder, etc.
14. ModifiedPainDETECT Questionnaire (mPDQ) \>18
15. Current use of any non-opioids centrally acting analgesics including gabapentin, pregabalin, duloxetine, tricyclic antidepressants (e.g. amitriptyline) for pain management within 12 weeks prior to screening.
16. Started taking oral or injectable GLP-1 products in the past 6 months as new regimen. Current use of a GLP-1 product is permitted if the participant has been on the product for \> 6 months and plans to continue the product at its current stable dose for the duration of the trial.
17. Started taking another concomitant medication within the past 12 weeks or changed dose of a concomitant medication within the past 12 weeks which could, in the opinion of the Principal Investigator or delegate, impact the participant's safety on the trial or the reliability of the outcome assessments.
18. Participate in another clinical trial and received study intervention currently or in the past 3 months
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 29 May 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.