Gastrocnemius Myofascial Release in Females With Knee Osteoarthritis

Official title

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

Overview

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.

Interventions

• 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 . T
• 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, superfi

Primary outcome measures

• 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.]

Secondary outcome measures (5)

• 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.]

Eligibility criteria

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 .

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Faculty of Physical Therapy, Cairo University — Giza

Identifiers

NCT: NCT07507175 · P.T.REC/012/006221

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗