New gel and stretching combo aims to ease nerve pain in knee arthritis
NCT ID NCT07598474
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a gel containing pregabalin, applied through the skin using ultrasound (phonophoresis), combined with calf muscle stretching, can reduce nerve pain and improve walking in people with grade III knee osteoarthritis. The trial includes 35 adults aged 40-70 who have both knee osteoarthritis and nerve pain. Participants will receive either the active treatment or a placebo gel with ultrasound, and changes in pain and mobility will be measured over four weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pregabalin-Encapsulated Hydrogel Phonophoresis
- What this could lead to
- If it works, this could offer a new, non-drug way to reduce nerve pain and improve mobility in advanced knee osteoarthritis without the side effects of oral medication.
- What could go wrong
- This is a small, early-stage study with only 35 participants. The treatment may not work better than standard care, and results may not apply to everyone with knee osteoarthritis.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Diagnosed Grade III knee osteoarthritis confirmed by Kellgren-Lawrence grading scale (radiograph within past 12 months or newly obtained). 2. Neuropathic pain component confirmed by DN-4 questionnaire (score ≥4). 3. Age between 40 and 70 years inclusive. 4. Both male and female participants. 5. Unilateral or bilateral knee involvement (if bilateral, the more symptomatic knee selected for assessment and treatment). 6. Willing and able to provide written informed consent. 7. Available to attend 4 sessions per week for 4 consecutive weeks (total 16 sessions). 8. Able to understand and follow verbal instructions (for MET). Exclusion Criteria: 1. Diabetic neuropathy (diagnosed or DN-4 score attributable to diabetes rather than knee OA). 2. Active skin lesions, wounds, infections, or dermatitis on the knee or calf. 3. Metal implants (including knee replacement), pacemaker, or other electronic implant (contraindications for ultrasound). 4. Received intra-articular knee injection (corticosteroid or hyaluronic acid) within the last 3 months. 5. Grade I, II, or IV knee osteoarthritis (Kellgren-Lawrence). 6. Aseptic arthritis of knee (rheumatoid, psoriatic, gouty). 7. Any lower extremity deformity (genu varum \>15°, genu valgum \>15°, fixed flexion deformity \>15°). 8. Previous knee replacement surgery (partial or total). 9. Known allergy or hypersensitivity to pregabalin, gabapentin, or any gel components. 10. Pregnant or lactating women (ultrasound safety in pregnancy not established for non-obstetric use). 11. Concurrent participation in another interventional study. 12. Diagnosis of fibromyalgia, complex regional pain syndrome, or other centralized pain disorder that might confound neuropathic pain assessment. 13. Active malignancy or history of knee malignancy. 14. Deep vein thrombosis or thrombophlebitis in lower limb.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Faisalabad
RECRUITINGFaisalābad, Punjab Province, 3800, Pakistan
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