Knee OsteoarthritisMFR/KNEE OANCT07507175
Gastrocnemius Myofascial Release in Females With Knee Osteoarthritis
A study testing GASTROCNEMIUS MYOFASCIAL RELEASE in people with Knee Osteoarthritis, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- GASTROCNEMIUS MYOFASCIAL RELEASE
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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 .
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- 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 .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Cairo University
Giza, Giza Governorate, 12613
Afaf Omar Tahoon, +201119870393, afaf_tahoon@cu.edu.eg
About this study
Official title: 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- GASTROCNEMIUS MYOFASCIAL RELEASE, sham Gastrocnemius MYOFASCIAL RELEASE
- Keywords
- Knee Osteoarthritis, Myofascial release, Physical function, gastrocnemius
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GASTROCNEMIUS MYOFASCIAL RELEASEProcedure or surgery
Also called Gastrocnemius MFR
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
sham Gastrocnemius MYOFASCIAL RELEASEProcedure or surgery
Also called Placebo 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: sham Gastrocnemius MYOFASCIAL RELEASE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 )
- 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start3 Jan 2026
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Mahmoud Hammam Fathi Soliman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507175
- Sponsor's protocol ID
- P.T.REC/012/006221
- Acronym
- MFR/KNEE OA
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gastrocnemius Myofascial Release on Pain and Physical Function Outcomes in Females With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07507175
- Acronym / sponsor ID
- MFR/KNEE OA / P.T.REC/012/006221
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Myofascial release, Physical function, gastrocnemius
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jan 2026 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GASTROCNEMIUS MYOFASCIAL RELEASE | Experimental | Procedure: GASTROCNEMIUS MYOFASCIAL RELEASEGM 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 |
| sham GASTROCNEMIUS MYOFASCIAL RELEASE | Sham comparator | Procedure: sham Gastrocnemius MYOFASCIAL RELEASEsham 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 |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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 .
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GASTROCNEMIUS MYOFASCIAL RELEASEAlso: Gastrocnemius MFRGastrocnemius 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 | Procedure or surgery | GASTROCNEMIUS MYOFASCIAL RELEASE |
| sham Gastrocnemius MYOFASCIAL RELEASEAlso: Placebo Gastrocnemius Myofascial ReleasePatient 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 | Procedure or surgery | sham GASTROCNEMIUS MYOFASCIAL RELEASE |
Primary outcome
Pain during rest and single leg squat (Visual analogue scale)
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.
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.
5 secondary outcomes
Physical function (40 m fast-paced walk test )
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.
Physical function (the 30-s chair-stand test)
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.
Physical function (a stair-climb test )
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.
Foot posture (foot posture index 6)
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.
Knee Disability (Arabic version of Algofunctional index of lequense)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GASTROCNEMIUS MYOFASCIAL RELEASE in people with Knee Osteoarthritis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hend Hammam Soliman, Bachelor's Degree (+201008380834, hendhammam18@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during rest and single leg squat (Visual analogue scale) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.