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New treatment option for Knee Osteoarthritis
Official title Pregabalin Phonophoresis and MET for Knee Osteoarthritis
ClinicalTrials.gov ID: NCT07598474
What this study is testing
What is Pregabalin-Encapsulated Hydrogel Phonophoresis?
Pregabalin-Encapsulated Hydrogel Phonophoresis is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for knee osteoarthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 60
You may be able to join if
- 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).
You likely can't join if
- 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).
See the full eligibility 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).
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Faisalābad, Punjab Province, Pakistan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Faisalābad, Punjab Province, Pakistan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.