Gastrocnemius Myofascial Release in Females With Knee Osteoarthritis (MFR/KNEE OA)

Effect of Gastrocnemius Myofascial Release on Pain and Physical Function Outcomes in Females With Knee Osteoarthritis

The goal of this clinical trial is to determine whether gastrocnemius myofascial release is effective in reducing pain and improving physical function in females with knee osteoarthritis.

The main question this study aims to answer are:

• Does adding gastrocnemius MFR to conventional physical therapy treatment influence pain, physical function, foot posture, and knee disability compared to conventional physical therapy treatment and sham MFR in knee osteoarthritis?
• Participants receive gastrocnemius myofascial release treatment or sham gastrocnemius myofascial release treatment for 3 times weekly for 4 weeks for both groups.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: GASTROCNEMIUS MYOFASCIAL RELEASE; Procedure: sham Gastrocnemius MYOFASCIAL RELEASE

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hend Hammam Soliman, Bachelor's Degree; Phone Number: +201008380834; Email: hendhammam18@live.com
• Study Contact Backup: Name: Afaf Omar Tahoon; Phone Number: +201119870393; Email: afaf_tahoon@cu.edu.eg

Study Locations

• Egypt
  • Giza Governorate
    • Giza, Giza Governorate, Egypt, 12613
      • Recruiting
      • Faculty of physical therapy, Cairo University
      • Contact: Afaf Omar Tahoon; Phone Number: +201119870393; Email: afaf_tahoon@cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients' ages ranged between 45 and 55 years .
• BMI ≤35
• Patients with a diagnosis of primary KOA according to the American College of Rheumatology classification at the screening visit .
• Onset of symptomatic knee osteoarthritis of ≥3 months
• Patients with grade II and III OA of the Kellgren and Lawrence system for classification of osteoarthritis .
• At least one active trigger point in GM
• If both knees were diagnosed as OA, the most affected one was selected.
• Current pain intensity on the Visual Analogue Scale (VAS) ≥4/10.
• Subjects have sufficient cognition that enables them to understand the requirements of the study, comply with the study procedures, and visit schedule.
• Diagnostic Criteria of KOA

A diagnosis of knee osteoarthritis was made when knee pain is present, plus Osteophytes on radiographs, plus at least 1 of the following 3:

• Age > 50 years
• Morning stiffness < 30 minutes
• Crepitus on active motion

Exclusion Criteria:

• Patients with any previous knee surgeries or lower limb fractures.
• Chronic inflammatory diseases such as rheumatoid arthritis.
• Signs of moderately significant knee synovitis include a warm and swollen (red) knee
• History and/or physical examination findings compatible with knee internal derangement (e.g, positive Thessaly test).
• Pregnancy
• Patients who had undergone arthroscopy or treatment with intra-articular hyaluronic acid during the previous 6 months .
• Use of NSAIDs one week before the screening visit .
• Orthopedic diseases, or congenital musculoskeletal deformities, or neurological disorders that may affect or interfere with the therapeutic effect.
• Participated in other intervention studies (strength training program or physiotherapy treatment for knee osteoarthritis) in the current period and the past 6 months .
• Habitual use of psychotropic or narcotic analgesics for ≥1 week within 8 weeks prior to screening .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GASTROCNEMIUS MYOFASCIAL RELEASE; GM MFR and TrP pressure release with a combination of manual physical therapy (knee mobilization), supervised exercise (riding a stationary bike, muscle strengthening exercises for the hip and knee, and self-stretching of lower limb muscles), and TENS	Procedure: GASTROCNEMIUS MYOFASCIAL RELEASE; Gastrocnemius MFR Procedures : Technique 1: With the elbow flexed to 90◦ and take up a contact in the Tendo Achilles. Establish a line of tension in a superior direction.; Technique 2: with the index and middle fingers of each hand to take up a contact on the tendons of the GM at the epicondyles of the femur. Establish a line of tension in an inferior direction.; Technique 3: With the index, middle and ring fingers of each hand to get into the medial and lateral aspects of the calcaneus . The release begins proximally.; (5 minutes× 1 repetition) for the three technique; Gastrocnemius TrP pressure release is repeated for 90 seconds (usually 3 repetitions).; Anterior glide & Posterior glide (grade IV); Riding a stationary bike for 5 minutes; Quadriceps set exercise; Terminal knee extension; Step-up exercises for 30 seconds; Lateral Step-up for 30 seconds.; Self-stretching of Hamstring, Rectus femoris ,and Calf muscles.; TENS for 20 minutes; Other Names: Gastrocnemius MFR
Sham Comparator: sham GASTROCNEMIUS MYOFASCIAL RELEASE; sham GM MFR with a combination of manual physical therapy (knee mobilization), supervised exercise (riding a stationary bike, muscle strengthening exercises for the hip and knee, and self-stretching of lower limb muscles), and TENS	Procedure: sham Gastrocnemius MYOFASCIAL RELEASE; Patient position: Prone, with feet off the end of the table to allow for adequate dorsiflexion. Therapist's position:, facing toward the feet while standing at the patient's side, at around mid-thigh level for techniques. Technique: one hand is positioned at the attachments of the GM at the epicondyles of the femur, and the other at the Achilles tendon without applying significant pressure or tissue deformation. Mimic the hand movements of real myofascial release (e.g., slow stroking, superficial gliding) but avoid: Deep pressure, Skin stretch, and Muscle compression.; Anterior glide & Posterior glide (grade IV); Riding a stationary bike for 5 minutes; Quadriceps set exercise; Terminal knee extension; Step-up exercises for 30 seconds; Lateral Step-up for 30 seconds.; Self-stretching of Hamstring, Rectus femoris ,and Calf muscles.; TENS for 20 minutes; Other Names: Placebo Gastrocnemius Myofascial Release

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain during rest and single leg squat (Visual analogue scale)	Participants are instructed to draw a vertical mark on the line indicating their pain level during rest and single leg squat -single leg squat: The Participants stand on the limb being evaluated, with the other leg lifted off the ground so that the hip is flexed to approximately 45 degrees and the knee to approximately 90 degrees. The Participants' shoulders is forward flexed to 90 degrees with the elbows in full extension and the hands clasp together in front. The Participants are forward flexed to squat down until feeling pain and discomfort and return to the start position.	pain is measured at baseline at the first session and reassessed at the end of the second week, and at the end of four weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical function (40 m fast-paced walk test )	- 40MFPW : The participants walk as quickly and safely as possible on a 10-m walkway, turn around a cone placed 2 m beyond each end of the walkway, and return for a total distance of 40 m.	Physical function is measured at baseline at the first session and reassessed at the end of the second week, and at the end of four weeks.
Physical function (the 30-s chair-stand test)	- 30sCST : The participants stand up completely from a sitting position from an unarmed and straight-backed chair ; and then completely back down until they are completely on the seat. The maximum number of chair-stand repetitions completed in 30 seconds is recorded.	Physical function is measured at baseline at the first session and reassessed at the end of the second week, and at the end of four weeks.
Physical function (a stair-climb test )	- 9-s SCT: The participants ascend and descend nine stairs as quickly as possible but in a safe manner. The time for the participants to complete the ascending and descending tasks is recorded.	Physical function is measured at baseline at the first session and reassessed at the end of the second week, and at the end of four weeks.
Foot posture (foot posture index 6)	FPI-6 is considered a quick, easy, inexpensive, and multi-segmental clinical quantification tool, which can assess the posture of the foot. FPI-6 score consisted of six items: (1) Talar head palpation, (2) curves above and below the lateral malleolus, (3) Talonavicular joint bulging (4) Calcaneal frontal plane position, (5) Medial longitudinal arch height and congruence (6) Forefoot abduction or adduction. the participant are in a standing, relaxed stance position, arms by the side, and looking straight ahead. Then, take several steps in place before settling into a comfortable stance position. The assessor needs to be able to move around the patient during the assessment and to have uninterrupted access to the posterior aspect of the leg and foot. Approximately two minutes for the assessment to be conducted. the total score ranging from -12 to +12.; Pronated postures are given a positive value; Supinated features are given a negative value; neutral foot score around zero	Foot posture is measured at baseline at the first session and reassessed at the end of the second week, and at the end of four weeks.
Knee Disability (Arabic version of Algofunctional index of lequense)	The Lequesne Algofunctional Index is a 10-question interview format questionnaire that was designed as a single unit. These 10 parameters are divided into three sections to assess 'pain or discomfort' (L1), 'maximum distance walked' (L2), and 'activities of daily living' (L3). The Lequesne index directly aggregates symptoms and function, which results in a single global index score ranging from 0 (no pain, no disability) to 24 (maximum pain, stiffness, and disability).	Knee Disability is measured at baseline at the first session and reassessed at the end of the second week, and at the end of four weeks.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Knee Osteoarthritis; Physical function; Myofascial release; gastrocnemius
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: P.T.REC/012/006221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No