Therapeutic Exercises for Pain and Disability in Knee Osteoarthritis

NCT07128875 | Not Yet Recruiting

• 1 other identifier: RIPHAH-REC Naimat ullah 01018
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of structured therapeutic exercises in reducing pain and disability among older adults diagnosed with knee osteoarthritis. The intervention will involve a supervised physical therapy program targeting muscle strength, joint mobility, and functional capacity. Participants will undergo 6 weeks of therapy, and improvements in pain and physical function will be measured using validated scales.

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis, Knee Pain, Therapeutic Exercise

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  Pain intensity will be assessed using the Visual Analog Scale (VAS), which ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent worse outcomes.

  6 Months

Secondary Outcomes (1)

• Change in Physical Disability

  6months

Study Arms (2)

Exercise + TENS + Hot Pack

EXPERIMENTAL

Participants in this group will receive a structured therapeutic exercise program designed to improve physical function and reduce pain in patients with knee osteoarthritis. The session includes: Warm-Up (10 min): Light walking or stationary cycling Range of Motion (ROM) Exercises: Heel slides, seated knee flexion/extension Strengthening Exercises: Quadriceps sets Straight leg raises Mini squats (within pain-free range) Seated knee extensions using resistance bands Stretching Exercises: Hamstring stretch Calf stretch Quadriceps stretch Cool Down (5-10 min): Breathing and relaxation techniques Modalities: Hot Pack: 15 minutes (applied pre- and post-exercise) TENS: 10 minutes (applied pre- and post-exercise using dual-channel portable TENS unit - \[Brand/Model, if available\])

Other: Exercise + TENS + Hot Pack

Exercise Only (Control)

ACTIVE COMPARATOR

Participants in the control group will follow the same structured therapeutic exercise program as the experimental group. However, TENS will be replaced with a sham procedure that mimics device placement without electrical stimulation. Warm-Up (10 min): Light walking or stationary cycling Range of Motion (ROM) Exercises: Heel slides, seated knee flexion/extension Strengthening Exercises: Quadriceps sets Straight leg raises Mini squats (within pain-free range) Seated knee extensions using resistance bands Stretching Exercises: Hamstring stretch Calf stretch Quadriceps stretch Cool Down (5-10 min): Breathing and relaxation techniques Modalities: Hot Pack: 15 minutes (if applicable) Sham TENS: Electrodes applied without current

Other: Exercise

Interventions

Exercise + TENS + Hot Pack OTHER

Therapeutic Exercises with Hot Pack and TENS This intervention focuses on improving physical function and reducing pain through structured therapeutic exercises for knee OA patients. The program includes Warm-Up (10 min): Light walking or stationary cycling. 2. Range of Motion (ROM) Exercises: Heel slides, seated knee flexion/extension. 3. Strengthening Exercises: Quadriceps sets Straight leg raises Mini squats (pain-free range) Seated knee extensions with resistance band 4. Stretching Exercises: Hamstring stretch Calf stretch Quadriceps stretch 5. Cool Down (5-10 min): Breathing and relaxation. 6. Hot Pack (15 min) + TENS (10 min): Applied pre and post exercises for pain relief and muscle relaxation.

Exercise + TENS + Hot Pack

Exercise OTHER

Warm-Up (10 min): Light walking or stationary cycling. 2. Range of Motion (ROM) Exercises: Heel slides, seated knee flexion/extension. 3. Strengthening Exercises: Quadriceps sets Straight leg raises Mini squats (pain-free range) Seated knee extensions with resistance band 4. Stretching Exercises: Hamstring stretch Calf stretch Quadriceps stretch 5.

Exercise Only (Control)

Eligibility Criteria

• Age: 35 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with knee OA
• Aged 50-75 years
• Experiencing pain or functional limitation
• Able to attend supervised sessions
• Provided informed consent

You may not qualify if:

• Severe cardiovascular or neurological conditions
• Acute injury or fracture in lower limb
• Uncontrolled hypertension or diabetes

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah international University Malakand Campus

Malakand, Kpk, 23060, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Exercise; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Dr Nadeem Ahmad, MS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr.Nadeem Ahmad, MS

CONTACT

03451915105; n.ahmad@riphah.edu.pk

Dr.Nadeem Ahmad, MS

CONTACT

03028367237; drnadeem765@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: A triple-blind protocol was implemented. Participants with knee osteoarthritis, treating therapists, and outcome assessors were blinded to group assignments. Sham procedures were used in the control group to mimic the active treatment without therapeutic effect. Blinding integrity was periodically assessed through questionnaires evaluating participants' and assessors' guesses regarding group allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group A Therapeutic Group

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 19, 2025
• Study Start: August 17, 2025
• Primary Completion (Estimated): July 17, 2026
• Study Completion (Estimated): July 17, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)