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

NCT ID: NCT06583707

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-23
• Study Completion Date: 2025-03-31

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

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.

Conditions

Tendinopathy; Rotator Cuff

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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

Group Type: ACTIVE_COMPARATOR

Dry needling with and without ultrasound guidance

Intervention Type: 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.

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

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

Group Type: SHAM_COMPARATOR

Dry needling with and without ultrasound guidance

Intervention Type: 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 real dry needling on the infraspinatus muscle + exercise

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

Group Type: ACTIVE_COMPARATOR

Dry needling with and without ultrasound guidance

Intervention Type: 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

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

Group Type: SHAM_COMPARATOR

Dry needling with and without ultrasound guidance

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alcala

OTHER

Sponsor Role: lead

Responsible Party

Enrique Coca

Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enrique Coca, Student

Role: PRINCIPAL_INVESTIGATOR

University of Alcala

Locations

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

Alcalá de Henares, Madrid, Spain

Countries

Spain

Central Contacts

Enrique Coca, Student

Role: CONTACT

enrique.coca@edu.uah.es

+34671136617

Facility Contacts

Enrique Coca, Student

Role: primary

enrique.coca@edu.uah.es

+34671136617

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Other Identifiers

Dry Needling Infraspinatus

Identifier Type: -

Identifier Source: org_study_id