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

NCT06584500 | Not Yet Recruiting

• 1 other identifier: CEIM/2024/4/103
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Greater Trocantheric Pain Syndrome

Keywords

greater trochanteric pain syndrome, potential contraction, dry needling, gluteus medius.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• WOMAC hip scale

  From enrollment to the end of treatment at 4 months

• Hip Abduction Strength

  From enrollment to the end of treatment at 4 months

• Pain

  From enrollment to the end of treatment at 4 months

• Passive Hip Range of Motion

  From enrollment to the end of treatment at 4 months

Study Arms (2)

E Group

EXPERIMENTAL

Experimental group which receives real dry needling

Other: Dry needling

C Group

SHAM COMPARATOR

Control group which receives sham dry needling

Other: Sham Dry Needling

Interventions

Dry needling OTHER

Dry 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.

E Group

Sham Dry Needling OTHER

The 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

C Group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Universidad de Alcalá

Alcalá de Henares, Madrid, Spain

Location

Related Publications (14)

• Brennan KL, Allen BC, Maldonado YM. Dry Needling Versus Cortisone Injection in the Treatment of Greater Trochanteric Pain Syndrome: A Noninferiority Randomized Clinical Trial. J Orthop Sports Phys Ther. 2017 Apr;47(4):232-239. doi: 10.2519/jospt.2017.6994. Epub 2017 Mar 3.

  PMID: 28257614 BACKGROUND

• Ceballos-Laita L, Jimenez-Del-Barrio S, Marin-Zurdo J, Moreno-Calvo A, Marin-Bone J, Albarova-Corral MI, Estebanez-de-Miguel E. Effectiveness of Dry Needling Therapy on Pain, Hip Muscle Strength, and Physical Function in Patients With Hip Osteoarthritis: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 May;102(5):959-966. doi: 10.1016/j.apmr.2021.01.077. Epub 2021 Feb 7.

  PMID: 33567336 BACKGROUND

• Fernandez-de-Las-Penas C, Nijs J. Trigger point dry needling for the treatment of myofascial pain syndrome: current perspectives within a pain neuroscience paradigm. J Pain Res. 2019 Jun 18;12:1899-1911. doi: 10.2147/JPR.S154728. eCollection 2019.

  PMID: 31354339 BACKGROUND

• French HP, Woodley SJ, Fearon A, O'Connor L, Grimaldi A. Physiotherapy management of greater trochanteric pain syndrome (GTPS): an international survey of current physiotherapy practice. Physiotherapy. 2020 Dec;109:111-120. doi: 10.1016/j.physio.2019.05.002. Epub 2019 Jun 2.

  PMID: 31493863 BACKGROUND

• Dieterich AV, Pickard CM, Strauss GR, Deshon LE, Gibson W, McKay J. Muscle thickness measurements to estimate gluteus medius and minimus activity levels. Man Ther. 2014 Oct;19(5):453-60. doi: 10.1016/j.math.2014.04.014. Epub 2014 May 10.

  PMID: 24880207 BACKGROUND

• Schneider E, Moore ES, Stanborough R, Slaven E. Effects of Trigger Point Dry Needling on Strength Measurements and Activation Levels of the Gluteus Medius: A Quasi-Experimental Randomized Control Study. Int J Sports Phys Ther. 2022 Dec 1;17(7):1404-1416. doi: 10.26603/001c.55536. eCollection 2022.

  PMID: 36518833 BACKGROUND

• Fearon AM, Scarvell JM, Neeman T, Cook JL, Cormick W, Smith PN. Greater trochanteric pain syndrome: defining the clinical syndrome. Br J Sports Med. 2013 Jul;47(10):649-53. doi: 10.1136/bjsports-2012-091565. Epub 2012 Sep 14.

  PMID: 22983121 BACKGROUND

• Grimaldi A, Mellor R, Hodges P, Bennell K, Wajswelner H, Vicenzino B. Gluteal Tendinopathy: A Review of Mechanisms, Assessment and Management. Sports Med. 2015 Aug;45(8):1107-19. doi: 10.1007/s40279-015-0336-5.

  PMID: 25969366 BACKGROUND

• Hilligsoe M, Rathleff MS, Olesen JL. Ultrasound Definitions and Findings in Greater Trochanteric Pain Syndrome: A Systematic Review. Ultrasound Med Biol. 2020 Jul;46(7):1584-1598. doi: 10.1016/j.ultrasmedbio.2020.03.008. Epub 2020 May 5.

  PMID: 32381380 BACKGROUND

• Plinsinga ML, Ross MH, Coombes BK, Vicenzino B. Physical findings differ between individuals with greater trochanteric pain syndrome and healthy controls: A systematic review with meta-analysis. Musculoskelet Sci Pract. 2019 Oct;43:83-90. doi: 10.1016/j.msksp.2019.07.009. Epub 2019 Jul 25.

  PMID: 31369906 BACKGROUND

• Segal NA, Felson DT, Torner JC, Zhu Y, Curtis JR, Niu J, Nevitt MC; Multicenter Osteoarthritis Study Group. Greater trochanteric pain syndrome: epidemiology and associated factors. Arch Phys Med Rehabil. 2007 Aug;88(8):988-92. doi: 10.1016/j.apmr.2007.04.014.

  PMID: 17678660 BACKGROUND

• Lespasio MJ. Lateral Hip Pain: Relation to Greater Trochanteric Pain Syndrome. Perm J. 2022 Jun 29;26(2):83-88. doi: 10.7812/TPP/21.110. Epub 2022 Jun 15.

  PMID: 35933677 BACKGROUND

• (1) Fredericson M, Lin CY, Chew K. Greater Trochanteric Pain Syndrome. Essentials of Physical Medicine and Rehabilitation 2021 -02-27:346.

  BACKGROUND

• Grimaldi A, Mellor R, Nicolson P, Hodges P, Bennell K, Vicenzino B. Utility of clinical tests to diagnose MRI-confirmed gluteal tendinopathy in patients presenting with lateral hip pain. Br J Sports Med. 2017 Mar;51(6):519-524. doi: 10.1136/bjsports-2016-096175. Epub 2016 Sep 15.

  PMID: 27633027 BACKGROUND

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Central Study Contacts

María Teresa María Teresa Suárez del Villar Estéfano, Phisiotherapy

CONTACT

(+34) 697641648; teresasuarez96@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: María Teresa Suárez del Villar Estéfano

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 4, 2024
• Study Start: October 15, 2024
• Primary Completion: September 8, 2025
• Study Completion: November 8, 2025
• Last Updated: September 4, 2024

Record last verified: 2024-08

Locations

ES (1)