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Pregabalin Phonophoresis and MET for Knee Osteoarthritis

NCT07598474 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-05-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

COMBINATION_PRODUCT

Pregabalin-Encapsulated Hydrogel Phonophoresis

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.

OTHER

Gastrocnemius Muscle Energy Technique (Post-Isometric Relaxation)

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).

DEVICE

Aqua Gel Phonophoresis

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).

Sponsors & Collaborators

  • University of Faisalabad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-07-19
Completion
2026-07-19

Countries

  • Pakistan

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07598474 on ClinicalTrials.gov