Real Dry Needling and Placebo Dry Needling Applied With and Without Ultrasound Guidance on the Infraspinatus Muscle

Official title

Effect of the Application of Real Dry Needling and Placebo Dry Needling Applied With and Without Ultrasound Guidance on the Infraspinatus Muscle in Shoulder Pain and Functionality in Patients Diagnosed With Rotator Cuff Tendinopathy

Overview

The infraspinatus muscle is one of the four muscles that form the rotator cuff. The dry needling technique involves inserting a sterile needle to stimulate a myofascial trigger point with the aim of reducing pain and increasing range of motion and quality of life. This technique can be performed using ultrasound guidance, which allows us to visualize the needle at all times, but it can also be done using anatomical landmarks. This study includes a self-directed exercise plan for rotator cuff tendinopathy. Variables such as strength, shoulder functionality level, grip strength, and active range of motion will be measured. As part of the intervention, two dry needling sessions will be performed, 14 days apart, along with two different exercise programs. Three measurements will be taken, and the intervention will last for 6 weeks. The sample will be divided into four equal groups: Group 1: ultrasound-guided real dry needling; Group 2: ultrasound-guided placebo dry needling; Group 3: non-ultrasound-guided real dry needling; and Group 4: non-ultrasound-guided placebo dry needling

Detailed description

Pathologies affecting the rotator cuff are the most common among shoulder patho-logies. The infraspinatus muscle is one of the four muscles that make up the rotator cuff. Dry needling is a technique used to reduce pain and increase the range of motion. The ul-trasound-guided technique involves using an ultrasound device to visualize the needle and guide it to the target tissue. Physical exercise helps improve tendon recovery. Objective: To evaluate the effect of real dry needling and placebo dry needling, whether ultrasound-guided or not, on pain (VAS), shoulder functionality (SPADI questionnaire), grip strength (Jamar dynamometer), and ac-tive range of motion (electronic goniometer). A total of 76 subjects diagnosed by a physician with rotator cuff tendinopathy based on imaging, aged between 18 and 60 years, and meeting the inclusion and exclusion criteria, were divided into 4 groups: Group 1 (real ultrasound-guided dry needling on the infraspinatus muscle + exercise), Group 2 (placebo ultrasound-guided dry needling on the infraspinatus muscle + exercise), Group 3 (real non-ultrasound-guided dry needling on the infraspinatus muscle + exercise), and Group 4 (placebo non-ultrasound-guided dry needling on the infraspinatus muscle + exercise). The dry needling technique will be applied twice: at the beginning and at 14 days. The intervention duration is 6 weeks.

Interventions

• Procedure Dry needling with and without ultrasound guidance
  The dry needling technique involves inserting a sterile needle to stimulate a myofascial trigger point with the aim of reducing pain and increasing range of motion and quality of life. This technique can be performed using ultrasound guidance, which allows us to visualize the needle at all times, but it can also be done using anatomical landmarks. In the placebo dry needling technique, the needle will remain stationary in the subcutaneous tissue.

Primary outcome measures

• Pain (VAS) [Time frame: Before starting the treatment, at the end of the treatment, and six months after completing the treatment]

Secondary outcome measures (3)

• Shoulder functionality [Time frame: Before starting the treatment, at the end of the treatment, and six months after completing the treatment]
• Grip strength [Time frame: Before starting the treatment, at the end of the treatment, and six months after completing the treatment]
• Active range of motion [Time frame: Before starting the treatment, at the end of the treatment, and six months after completing the treatment]

Eligibility criteria

Inclusion criteria

Patients aged between 18 and 60 years. Patients diagnosed with rotator cuff tendinopathy by a physician. The physician must have determined this diagnosis based on an imaging test: ultrasound or MRI. Presence of a taut band in the infraspinatus muscle with active trigger points that reproduce the patient\'s symptoms upon pressure.

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Exclusion criteria

High-level athletes, patients diagnosed with capsulitis, patients with a history of humeral or scapular fracture, patients with a complete or partial rotator cuff tear, patients diagnosed with cancer, and patients with any contraindications related to dry needling, patients who have previously undergone shoulder surgery, patients with a history of shoulder dislocation, patients diagnosed with fibromyalgia, patients taking medication for shoulder pain, and pregnant patients

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Campus Científico-Tecnológico UAH Av. de León, 3A — Alcalá de Henares

Publications

• Serpi F, Albano D, Rapisarda S, Chianca V, Sconfienza LM, Messina C. Shoulder ultrasound: current concepts and future perspectives. J Ultrason. 2021 Jun 7;21(85):e154-e161. doi: 10.15557/JoU.2021.0025. Epub 2021 Jun 18. PMID 34258041
• de-Queiroz JHM, de-Medeiros MB, de-Lima RN, Cerdeira DQ. Exercise for rotator cuff tendinopathy. Rev Bras Med Trab. 2023 Feb 3;20(3):498-504. doi: 10.47626/1679-4435-2022-698. eCollection 2022 Jul-Sep. PMID 36793454
• Cooper K, Alexander L, Brandie D, Brown VT, Greig L, Harrison I, MacLean C, Mitchell L, Morrissey D, Moss RA, Parkinson E, Pavlova AV, Shim J, Swinton PA. Exercise therapy for tendinopathy: a mixed-methods evidence synthesis exploring feasibility, acceptability and effectiveness. Health Technol Assess. 2023 Oct;27(24):1-389. doi: 10.3310/TFWS2748. PMID 37929629
• Tahran O, Yesilyaprak SS. Effects of Modified Posterior Shoulder Stretching Exercises on Shoulder Mobility, Pain, and Dysfunction in Patients With Subacromial Impingement Syndrome. Sports Health. 2020 Mar/Apr;12(2):139-148. doi: 10.1177/1941738119900532. Epub 2020 Feb 4. PMID 32017660
• Aboelnour NH, Kamel FH, Basha MA, Azab AR, Hewidy IM, Ezzat M, Kamel NM. Combined effect of graded Thera-Band and scapular stabilization exercises on shoulder adhesive capsulitis post-mastectomy. Support Care Cancer. 2023 Mar 16;31(4):215. doi: 10.1007/s00520-023-07641-6. PMID 36922413
• Beaudart C, Rolland Y, Cruz-Jentoft AJ, Bauer JM, Sieber C, Cooper C, Al-Daghri N, Araujo de Carvalho I, Bautmans I, Bernabei R, Bruyere O, Cesari M, Cherubini A, Dawson-Hughes B, Kanis JA, Kaufman JM, Landi F, Maggi S, McCloskey E, Petermans J, Rodriguez Manas L, Reginster JY, Roller-Wirnsberger R, Schaap LA, Uebelhart D, Rizzoli R, Fielding RA. Assessment of Muscle Function and Physical Performa PMID 30972475
• Wahba MM, Selim M, Hegazy MM, Elgohary R, Abdelsalam MS. Eccentric Versus Concentric Exercises in Patients With Rheumatoid Arthritis and Rotator Cuff Tendinopathy: A Randomized Comparative Study. Ann Rehabil Med. 2023 Feb;47(1):26-35. doi: 10.5535/arm.22150. Epub 2023 Feb 15. PMID 36792052
• Dupuis F, Barrett E, Dube MO, McCreesh KM, Lewis JS, Roy JS. Cryotherapy or gradual reloading exercises in acute presentations of rotator cuff tendinopathy: a randomised controlled trial. BMJ Open Sport Exerc Med. 2018 Dec 26;4(1):e000477. doi: 10.1136/bmjsem-2018-000477. eCollection 2018. PMID 30622733

Identifiers

NCT: NCT06583707 · Dry Needling Infraspinatus

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗