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New gel and stretching combo aims to ease nerve pain in knee arthritis

NCT ID NCT07598474

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

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

40 to 60 years

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • The University of Faisalabad

    RECRUITING

    Faisalābad, Punjab Province, 3800, Pakistan

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