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

September 2, 2024 updated by: Teresa Suárez del Villar Estéfano, University of Alcala

Analysis of the Effect of Dry Needling on the Pelvitrochanteric Musculature on the Potential Contraction of the Gluteus Medius in Patients with Greater Trochanteric Pain Syndrome: Protocol for a Randomized Clinical Trial. Pilot Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: María Teresa María Teresa Suárez del Villar Estéfano, Phisiotherapy
  • Phone Number: (+34) 697641648
  • Email: teresasuarez96@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Potential Contraction with M-Mode
Time Frame: 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.
From enrollment to the end of treatment at 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC hip scale
Time Frame: 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.
From enrollment to the end of treatment at 4 months
Hip Abduction Strength
Time Frame: 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.
From enrollment to the end of treatment at 4 months
Pain
Time Frame: 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.
From enrollment to the end of treatment at 4 months
Passive Hip Range of Motion
Time Frame: 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.
From enrollment to the end of treatment at 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alcala

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 15, 2024

Primary Completion (Estimated)

September 8, 2025

Study Completion (Estimated)

November 8, 2025

Study Registration Dates

First Submitted

September 2, 2024

First Submitted That Met QC Criteria

September 2, 2024

First Posted (Actual)

September 4, 2024

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

September 2, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIM/2024/4/103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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