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

NCT ID: NCT06584500

Last Updated: 2024-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-15

Study Completion Date

2025-11-08

Brief Summary

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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

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Conditions

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Greater Trocantheric Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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E Group

Experimental group which receives real dry needling

Group Type EXPERIMENTAL

Dry needling

Intervention Type 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.

C Group

Control group which receives sham dry needling

Group Type SHAM_COMPARATOR

Sham Dry Needling

Intervention Type 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

Interventions

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Dry needling

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.

Intervention Type OTHER

Sham Dry Needling

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alcala

OTHER

Sponsor Role lead

Responsible Party

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Teresa Suárez del Villar Estéfano

María Teresa Suárez del Villar Estéfano

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad de Alcalá

Alcalá de Henares, Madrid, Spain

Site Status

Countries

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Spain

Central Contacts

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María Teresa María Teresa Suárez del Villar Estéfano, Phisiotherapy

Role: CONTACT

(+34) 697641648

Facility Contacts

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Universidad de Alcalá

Role: primary

91 885 4053 / 4044

References

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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.

Reference Type BACKGROUND
PMID: 28257614 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33567336 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31354339 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31493863 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24880207 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36518833 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22983121 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25969366 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32381380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31369906 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17678660 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35933677 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 27633027 (View on PubMed)

Other Identifiers

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CEIM/2024/4/103

Identifier Type: -

Identifier Source: org_study_id

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