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Pregabalin Phonophoresis and MET for Knee Osteoarthritis

ConditionKnee Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-60
SponsorUniversity of Faisalabad

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pregabalin-Encapsulated Hydrogel Phonophoresis

    Combination product

    Pregabalin (5% w/w) incorporated into a water-soluble, ultrasound-conductive gel base. Delivered via therapeutic ultrasound (Sonopuls 490, Enraf-Nonius) with parameters: continuous mode, frequency 1 MHz, intensity 1 W/cm², treatment duration 5 minutes, sound head moved in slow circular motion (2-3 cm/sec) over medial, lateral, and posterior knee regions. Approximately 0.5 mL of gel per cm² per session. Administered 4 sessions/week for 4 weeks (total 16 sessions). Prepared under sterile conditions, stored at 4°C, used within 14 days.

  • Gastrocnemius Muscle Energy Technique (Post-Isometric Relaxation)

    Other intervention

    Manual therapy technique performed with participant supine, legs extended. Therapist stabilizes distal femur and holds plantar foot. Participant performs plantarflexion isometric contraction against therapist resistance at \~25% maximum effort for 7-10 seconds (no joint movement). After relaxation, therapist passively dorsiflexes ankle to first point of tissue resistance (mild stretch, never pain) and holds for 10 seconds. Cycle repeated 4-5 times per session. Preceded by 10-minute hot pack application. Performed 4 sessions/week for 4 weeks (total 16 sessions).

  • Aqua Gel Phonophoresis

    Device

    Standard ultrasound conductive gel containing water, carbomer, propylene glycol, methylparaben, propylparaben (no active pharmaceutical ingredient). Delivered via therapeutic ultrasound (Sonopuls 490, Enraf-Nonius) with parameters: continuous mode, frequency 1 MHz, intensity 1 W/cm², treatment duration 5 minutes, sound head moved in slow circular motion (2-3 cm/sec) over medial, lateral, and posterior knee regions. Administered 4 sessions/week for 4 weeks (total 16 sessions).

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: Group A: Pregabalin Phonophoresis + Gastrocnemius METExperimental treatment 2 interventions
Group B: Group B: Aqua Gel Phonophoresis + Gastrocnemius METActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in Neuropathic Pain Component

Douleur Neuropathique 4 (DN-4) questionnaire. A validated 4-question (7-item) screening tool for neuropathic pain. Questions 1-2: patient interview regarding pain characteristics (burning, painful cold, electric shocks, tingling, pins and needles, numbness, itching). Questions 3-4: physical examination (hypoesthesia to touch, hypoesthesia to pinprick, brushing-evoked pain). Each item scored 0 (no) or 1 (yes). Total score range 0-10. A score ≥4 indicates presence of neuropathic pain component. Higher scores indicate greater neuropathic pain. Minimal clinically important difference for DN-4 in osteoarthritis: 2 points.

Time frame
Baseline (week 0, pre-intervention) and Week 4 (post-intervention, after 16 sessions)

Secondary outcomes

1

Change in Pain Intensity

Numeric Pain Rating Scale (NPRS). An 11-point scale from 0 to 10 where 0 = "no pain" and 10 = "worst pain imaginable." Participants rate their average knee pain over the past 24 hours. Administered verbally by outcome assessor. Minimal clinically important difference for knee osteoarthritis: 2 points.

Time frame
Baseline (week 0, pre-intervention) and Week 4 (post-intervention, after 16 sessions)
2

Change in Functional Mobility and Stiffness

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). A standardized, validated, disease-specific questionnaire for hip and knee osteoarthritis. Three subscales: Pain (5 items, score 0-20), Stiffness (2 items, score 0-8), Physical Function (17 items, score 0-68). Total score range 0-96. Higher scores indicate worse pain, stiffness, and functional limitation. Administered by self-report (paper form) with assistance if needed. Minimal clinically important difference for total WOMAC in knee osteoarthritis: 12-15 points.

Time frame
Baseline (week 0, pre-intervention) and Week 4 (post-intervention, after 16 sessions)

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

The University of FaisalabadRecruiting3800, Faisalābad, Punjab ProvincePakistanPakistan

Sponsors and contacts

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University of Faisalabad

Lead sponsor

Source ClinicalTrials.gov
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