CClinicalTrials.gg
RecruitingNCT07507175MFR/KNEE OAUpdated Apr 2, 2026

Gastrocnemius Myofascial Release in Females With Knee Osteoarthritis

An interventional study of GASTROCNEMIUS MYOFASCIAL RELEASE and sham Gastrocnemius MYOFASCIAL RELEASE in Knee Osteoarthritis, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to female participants aged 45 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
45 Years to 55 Years
Sex
Female
01

Study 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.
02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • Knee Osteoarthritis
  • Myofascial release
  • Physical function
  • gastrocnemius
03

In context

Osteoarthritis, Knee

3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's planned enrollment of 30 is below the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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 .
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureGASTROCNEMIUS 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

    Also known as: Gastrocnemius MFR

  • Proceduresham 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

    Also known as: Placebo Gastrocnemius Myofascial Release

06

What researchers measure

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.

    Time frame: 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

  1. 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.

    Time frame: 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.

  2. 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.

    Time frame: 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.

  3. 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.

    Time frame: 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.

  4. 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

    Time frame: 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.

  5. 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).

    Time frame: 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.

07

Study locations

1 of 1 sites recruiting
  • Faculty of Physical Therapy, Cairo University
    Giza, Giza Governorate 12613, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07507175
Lead sponsor
Cairo University
Responsible party
Hend Mahmoud Hammam Fathi Soliman (Master's Student, Faculty of Physical Therapy, Cairo University, Cairo University) — Principal investigator
First posted
Apr 2, 2026
Start date
Jan 3, 2026
Primary completion
Jul 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Apr 2, 2026

Study contacts

Hend Hammam Soliman, Bachelor's Degree
Contact
hendhammam18@live.com
+201008380834
Afaf Omar Tahoon
Contact
afaf_tahoon@cu.edu.eg
+201119870393

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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