Pregabalin delivered through the skin with ultrasound and calf stretching for knee osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with severe knee OA and neuropathic pain will receive pregabalin-encapsulated hydrogel delivered via phonophoresis, combined with Gastrocnemius Muscle Energy Technique, or a control of aqua gel phonophoresis. The trial examines whether the transdermal pregabalin delivery plus post-isometric relaxation improves neuropathic knee pain and function more than ultrasound with placebo-like gel. Eligible adults aged 40–70 with unilateral or the more affected knee will undergo 16 sessions over four weeks. Outcomes focus on pain related to neuropathic features and walking ability, with safety monitoring for device- and drug-related effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• The University of Faisalabad
  Faisalābad, Punjab Province, Pakistan Recruiting

Study contacts

• Study coordinator: Dr. Muhammad Muneeb Jafar, Doctor of Physical Therapy
• Email: muneebjafar.DPT@tuf.edu.pk
• Phone: +92 312 7000616

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.