Universidad de Alcalá
Alcalá de Henares, Madrid, Spain
Not Yet Recruiting
NCT Number: NCT06584500
Effect of Dry Needling on Gluteus Medius Contraction in Greater Trochanteric Pain Syndrome: a Pilot RCT Protocol
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
20 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
dry needling
OtherDry needling will be performed on the pelvitrochanteric musculature, targeting those muscles where the patient reports mechanical hyperalgesia points upon palpation that reproduce familiar and recognizable pain. No more than 3 different muscles will be treated, and no more than 2 needles will be used per muscle to reduce irritability. The Gluteus Medius muscle will be needled in all patients, and the Gluteus Minimus, Tensor Fasciae Latae (TFL), Piriformis, and obturator muscles will also be examined.
Dry needling will be performed using monofilament needles of different sizes, 0.30mm x 7.5mm, 6mm, and 4mm (AGUPUNT, APS®), depending on the muscle being treated."
During the dry needling procedure, an attempt will be made to provoke a local twitch response (LTR). Once achieved, the needle will be manipulated with rapid in-and-out movements in different directions until 4 to 6 LTRs are obtained, or if the participant verbally requests the intervention to stop.
Sham dry needling
OtherThe intervention protocol for sham dry needlig will be just as to the real dry needling procedure, but instead of inserting the needle into the muscle, the needle is manipulated to touch the skin without penetrating it. This may involve the use of retractable needles or simply making contact with the skin
Primary outcomes
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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.
Secondary outcomes
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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.
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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.
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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.
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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.
Study contacts
Contact information is provided by the study sponsor or research team.
María Teresa María Teresa Suárez del Villar Estéfano, Phisiotherapy
CONTACT
(+34) 697641648
Sponsors and collaborators
Lead sponsor
University of Alcala
Other
Registry information
Official study title
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
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Sep 4, 2024
- Registry last updated
- Sep 4, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.