Effect of Dry Needling on Gluteus Medius Contraction in Greater Trochanteric Pain Syndrome: a Pilot RCT Protocol

Not Applicable

Not yet recruiting

• Conditions: Greater Trocantheric Pain Syndrome

• Registration Number: NCT06584500
• Lead Sponsor: University of Alcala

Brief Summary

Grater trochanteric pain syndrome is a hip related pathology that causes lateral hip pain and lack of strength in abductor muscles such as the gluteus medius, which hinders functional activities and daily life, such as standing, walking, sleeping on the affected side... Lack of strength and eccentric control of the gluteus medius may be related to the apparition of myofascial trigger points that are susceptible to treatment with dry needling.

In this study, two groups of patients with greater trochanteric pain syndrome will be treated with dry needling, some of them with real dry needling, and others with sham dry needling. Ultrasound will be used to assess whether real dry needling in the pelvitrochanteric musculature improves the potential contraction of the gluteus medius, in relation to a baseline measurement and to sham dry needling.

This study is a randomised clinical trial protocol, pilot study, so there will be no previous references for the sample of both study groups. 3 dry needling interventions will be performed in 3 consecutive weeks, leaving 1 week between each intervention. Data will be collected for the variables to be investigated (potential contraction, pain, function, strength...) before the first intervention, after each intervention, 1 month after the last intervention and at 3 months.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-02
• Last Update Submitted: 2024-09-02
• Study First Posted: 2024-09-04
• Last Update Posted: 2024-09-04
• Study Start: 2024-10-15
• Primary Completion: 2025-09-08
• Study Completion: 2025-11-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Lateral hip pain lasting more than 3 months.
• Greater trochanteric pain syndrome compatible with changes on MRI.
• Clinical examination correlation: one of the following tests must be positive: FADER test, FABER test, hip adduction (ADD) test in side-lying position (DL), isometric contraction test in the ADD position, or single-leg stance test for 30 seconds.
• Pain/sensitization upon palpation of the trochanter.

Exclusion Criteria

• Radicular pain due to lumbar pathology.
• Osteoarthritis.
• Pelvic pathology that could refer pain to the hip.
• Needle phobia.
• Hip injection performed less than 6 months ago.
• Dry needling performed less than 1 month ago.
• Surgery or pathology of the lower limb that prevents single-leg support.
• Systemic diseases that could interfere with the pathological process.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Potential Contraction with M-Mode	From enrollment to the end of treatment at 4 months	The primary variable in this study will measure the potential contraction of the gluteus medius. This variable will be assessed using a Sonoscape E2 ultrasound machine with a 5 cm linear probe and the highest scanning speed. The probe will be positioned at the midpoint of the line connecting the anterior and posterior superior iliac spines. In longitudinal scanning, M-mode will be placed cranially to the hip joint capsule. Thickness will be measured from the inner surface of the fascial borders, with the unit of measurement in millimeters (mm). The contraction potential will be the difference between the thickness of the gluteus medius at rest and the thickness at 80% of the maximum voluntary isometric contraction.

Secondary Outcome Measures

Name	Time	Method
WOMAC hip scale	From enrollment to the end of treatment at 4 months	This is a scale validated in Spanish to measure disability. Barratt et al. recommend the use of condition-specific outcome measures, such as the VISA-G, which is not validated in Spanish. The WOMAC scale has been used to measure disability in patients with Greater Trochanteric Pain Syndrome (GTPS) who speak Spanish.
Hip Abduction Strength	From enrollment to the end of treatment at 4 months	This will be defined as the amount of force measured by a manual dynamometer during a maximum voluntary isometric contraction. Strength is measured in kilograms (kg) using an Activforce 2 Dynamometer ACTVDIN® model. Participants will lie supine, with the test leg in an anatomical position at 0º hip rotation, and the opposite leg slightly flexed. The dynamometer will be positioned 5 cm proximal to the lateral malleolus, held externally by the examiner, who will stand on the same side as the tested leg. The contraction will be maintained for five seconds, and three measurements will be taken to obtain an average value. If compensatory movements are detected during a measurement, it will not be recorded, and another measurement will be taken.
Pain	From enrollment to the end of treatment at 4 months	Participants will indicate their pain intensity on a 100 mm horizontal line, with \"no pain\"; at the far left (score 0) and \"worst imaginable pain\"; at the far right (score 10), in relation to the most intense pain episode experienced during daily activities. The Visual Analogue Scale (VAS) has been shown to effectively detect changes in pain, with a minimum clinically significant difference established at 13 mm.
Passive Hip Range of Motion	From enrollment to the end of treatment at 4 months	It will be measured using an 18 cm plastic universal goniometer (Sammons Preston-Rolyan®). The following movements will be measured: flexion, extension, internal rotation, external rotation, and abduction until the end range without pain. Each movement will be measured three times, and the average value will be used in the analysis.