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Clinical Trials/NCT07710209
NCT07710209CompletedNot Applicable

Efficacy of Instrument-Assisted Soft Tissue Mobilization as an Adjunct to Therapeutic Exercises in Individuals With Knee Osteoarthritis: A Parallel-Group Randomized Controlled Trial

Foundation of Medical Research and Laboratories, Pakistan1 site in 1 country50 target enrollmentStarted: February 1, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Numeric Pain Rating Scale (NPRS)

Study Overview

Brief Summary

To determine the efficacy of IASTM as an adjunct to therapeutic exercises on pain, range of motion, and functional performance in individuals with knee OA.

Detailed Description

Background: Knee osteoarthritis (OA) is a leading cause of chronic pain and functional limitation, particularly in older adults, and is associated with soft tissue restrictions, quadriceps weakness, and reduced joint mobility. Therapeutic exercise remains a cornerstone of conservative management, but persistent myofascial restrictions may limit its full benefit. Instrument-Assisted Soft Tissue Mobilization (IASTM) has been proposed as an adjunct technique to address fascial adhesions, improve tissue extensibility, and enhance the outcomes of exercise-based rehabilitation. However, evidence regarding its added value when combined with conventional therapeutic exercise in knee OA remains limited.

Objective

To determine the efficacy of IASTM as an adjunct to therapeutic exercises on pain, range of motion, and functional performance in individuals with knee OA.

Methodology: A parallel-group randomized controlled trial was conducted on 50 participants diagnosed with knee OA (Kellgren-Lawrence grade II-III), randomly allocated into two equal groups (n=25 each) using a computer-generated random sequence with allocation concealment. Group A received IASTM combined with a standardized therapeutic exercise protocol, while Group B received the therapeutic exercise protocol alone. Treatment was administered three times per week for 6 weeks. Outcome measures included the Numeric Pain Rating Scale (NPRS), Knee range of motion (goniometry), and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for functional status, assessed at baseline and post-intervention (6 weeks). Data were analyzed using paired and independent sample t-tests, with significance set at p<0.05.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
40 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Osteoarthritis, both gender, Age between 40-60 years. -

Exclusion Criteria

  • Not meeting the inclusion criteria, underwent recent surgery of lower limb.

Outcomes

Primary Outcomes

Numeric Pain Rating Scale (NPRS)

Time Frame: 6 weeks

The value were taken at base line and after 6 weeks of intervention

Knee range of motion (goniometry)

Time Frame: 6 weeks

The value were taken at base line and after 6 weeks of intervention

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Time Frame: 6 weeks

The value were taken at base line and after 6 weeks of intervention

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Foundation of Medical Research and Laboratories, Pakistan
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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