Effect of Dry Needling on Gluteus Medius Contraction in Greater Trochanteric Pain Syndrome: a Pilot RCT Protocol
NCT Number: NCT06584500
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Greater Trocantheric Pain Syndrome
Sponsor: University of Alcala
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-15
Completion Date: 2025-11-08

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.

Primary Outcome Measures: Potential Contraction with M-Mode, 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., From enrollment to the end of treatment at 4 months
Secondary Outcome Measures: WOMAC hip scale, 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., From enrollment to the end of treatment at 4 months|Hip Abduction Strength, 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., From enrollment to the end of treatment at 4 months|Pain, Participants will indicate their pain intensity on a 100 mm horizontal line, with \&#34;no pain\&#34;; at the far left (score 0) and \&amp;#34;worst imaginable pain\&amp;#34;; 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., From enrollment to the end of treatment at 4 months|Passive Hip Range of Motion, 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., From enrollment to the end of treatment at 4 months