Gastrocnemius Myofascial Release in Females With Knee Osteoarthritis

NCT07507175 | Recruiting

• 1 other identifier: P.T.REC/012/006221
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Myofascial release; Physical function; gastrocnemius

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Physical function (40 m fast-paced walk test )

  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)

  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 )

  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)

  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)

  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.

Study Arms (2)

GASTROCNEMIUS MYOFASCIAL RELEASE

EXPERIMENTAL

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

sham GASTROCNEMIUS MYOFASCIAL RELEASE

SHAM COMPARATOR

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

Interventions

GASTROCNEMIUS MYOFASCIAL RELEASE PROCEDURE

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

Also known as: Gastrocnemius MFR

GASTROCNEMIUS MYOFASCIAL RELEASE

sham Gastrocnemius MYOFASCIAL RELEASE PROCEDURE

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

Also known as: Placebo Gastrocnemius Myofascial Release

sham GASTROCNEMIUS MYOFASCIAL RELEASE

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Giza Governorate, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Hend Hammam Soliman, Bachelor's Degree

CONTACT

+201008380834; hendhammam18@live.com

Afaf Omar Tahoon

CONTACT

+201119870393; afaf_tahoon@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student, Faculty of Physical Therapy, Cairo University

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: April 2, 2026
• Study Start: January 3, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)