Pregabalin Phonophoresis and MET for Knee Osteoarthritis
Recruiting · NCT07598474 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Faisalabad
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Knee osteoarthritis (OA) is a common condition causing pain, stiffness, and difficulty walking. Many patients with advanced (Grade III) knee OA also experience neuropathic pain - burning, tingling, or electric shock sensations - which is harder to treat with standard physiotherapy. Oral pregabalin works for neuropathic pain but causes side effects like dizziness and drowsiness. This study tests whether delivering pregabalin through the skin using ultrasound (phonophoresis), combined with calf muscle stretching (Muscle Energy Technique), can reduce nerve pain and improve walking better than ultrasound alone.
Who can take part
Inclusion criteria
- Diagnosed Grade III knee osteoarthritis confirmed by Kellgren-Lawrence grading scale (radiograph within past 12 months or newly obtained).
- Neuropathic pain component confirmed by DN-4 questionnaire (score ≥4).
- Age between 40 and 70 years inclusive.
- Both male and female participants.
- Unilateral or bilateral knee involvement (if bilateral, the more symptomatic knee selected for assessment and treatment).
- Willing and able to provide written informed consent.
- Available to attend 4 sessions per week for 4 consecutive weeks (total 16 sessions).
- Able to understand and follow verbal instructions (for MET).
Exclusion criteria
- Diabetic neuropathy (diagnosed or DN-4 score attributable to diabetes rather than knee OA).
- Active skin lesions, wounds, infections, or dermatitis on the knee or calf.
- Metal implants (including knee replacement), pacemaker, or other electronic implant (contraindications for ultrasound).
- Received intra-articular knee injection (corticosteroid or hyaluronic acid) within the last 3 months.
- Grade I, II, or IV knee osteoarthritis (Kellgren-Lawrence).
- Aseptic arthritis of knee (rheumatoid, psoriatic, gouty).
- Any lower extremity deformity (genu varum \>15°, genu valgum \>15°, fixed flexion deformity \>15°).
- Previous knee replacement surgery (partial or total).
- Known allergy or hypersensitivity to pregabalin, gabapentin, or any gel components.
- Pregnant or lactating women (ultrasound safety in pregnancy not established for non-obstetric use).
- Concurrent participation in another interventional study.
- Diagnosis of fibromyalgia, complex regional pain syndrome, or other centralized pain disorder that might confound neuropathic pain assessment.
- Active malignancy or history of knee malignancy.
- Deep vein thrombosis or thrombophlebitis in lower limb.
Where it is running
1 location listed.
- The University of Faisalabad - Faisalābad, Punjab Province, Pakistan