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

NCT06583707 | Not Yet Recruiting

• 1 other identifier: Dry Needling Infraspinatus
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tendinopathy; Rotator Cuff

Keywords

Dry needling; Rotator cuff; Pain; Tendinopathy; ultrasound-guided; exercise

Outcome Measures

Primary Outcomes (1)

• Pain (VAS)

  To assess the pain variable, the Visual Analog Scale (VAS) will be used. This scale consists of a range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. The patient autonomously selects a number from this scale based on the level of pain they feel

  Before starting the treatment, at the end of the treatment, and six months after completing the treatment

Secondary Outcomes (3)

• Shoulder functionality

  Before starting the treatment, at the end of the treatment, and six months after completing the treatment

• Grip strength

  Before starting the treatment, at the end of the treatment, and six months after completing the treatment

• Active range of motion

  Before starting the treatment, at the end of the treatment, and six months after completing the treatment

Study Arms (4)

Real ultrasound-guided dry needling on the infraspinatus muscle + exercise

ACTIVE COMPARATOR

Patients who undergo ultrasound-guided real dry needling, using the ultrasound to visualize the needle, and who follow an exercise program.

Procedure: Dry needling with and without ultrasound guidance

Placebo ultrasound-guided dry needling on the infraspinatus muscle + exercise

SHAM COMPARATOR

Patients who will undergo ultrasound-guided placebo dry needling on the infraspinatus muscle and will follow an established exercise protocol.

Procedure: Dry needling with and without ultrasound guidance

Non-ultrasound-guided real dry needling on the infraspinatus muscle + exercise

ACTIVE COMPARATOR

Patients who will undergo non-ultrasound-guided dry needling on the infraspinatus muscle and will follow an established exercise protocol

Procedure: Dry needling with and without ultrasound guidance

Non-ultrasound-guided placebo dry needling on the infraspinatus muscle + exercise

SHAM COMPARATOR

Patients who will undergo non-ultrasound-guided placebo dry needling on the infraspinatus muscle and will follow an established exercise protocol

Procedure: Dry needling with and without ultrasound guidance

Interventions

Dry needling with and without ultrasound guidance PROCEDURE

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.

Non-ultrasound-guided placebo dry needling on the infraspinatus muscle + exercise; Non-ultrasound-guided real dry needling on the infraspinatus muscle + exercise; Placebo ultrasound-guided dry needling on the infraspinatus muscle + exercise; Real ultrasound-guided dry needling on the infraspinatus muscle + exercise

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Campus Científico-Tecnológico UAH Av. de León, 3A

Alcalá de Henares, Madrid, 28805, Spain

Location

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 Performance in Daily Clinical Practice : A position paper endorsed by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO). Calcif Tissue Int. 2019 Jul;105(1):1-14. doi: 10.1007/s00223-019-00545-w. Epub 2019 Apr 10.

  PMID: 30972475 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Kinsella R, Cowan SM, Watson L, Pizzari T. A comparison of isometric, isotonic concentric and isotonic eccentric exercises in the physiotherapy management of subacromial pain syndrome/rotator cuff tendinopathy: study protocol for a pilot randomised controlled trial. Pilot Feasibility Stud. 2017 Nov 14;3:45. doi: 10.1186/s40814-017-0190-3. eCollection 2017.

  PMID: 29163981 BACKGROUND

• Roch M, Morin M, Gaudreault N. Immediate Effect of Dry Needling on the Viscoelastic Properties of a Trigger Point on the Infraspinatus Muscle Measured with MyotonPRO. Physiother Can. 2022 Jun 17;74(3):232-239. doi: 10.3138/ptc-2020-0095. eCollection 2022 Aug.

  PMID: 37325218 BACKGROUND

MeSH Terms

Conditions

Tendinopathy; Pain; Motor Activity

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Enrique Coca, Student

  University of Alcala

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrique Coca, Student

CONTACT

+34671136617; enrique.coca@edu.uah.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Study Record Dates

• First Submitted: September 1, 2024
• First Posted: September 4, 2024
• Study Start: September 23, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)