Real Dry Needling and Placebo Dry Needling Applied With and Without Ultrasound Guidance on the Infraspinatus Muscle
NCT Number: NCT06583707
Acronym: DN-INFR-RCT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tendinopathy|Rotator Cuff
Interventions: PROCEDURE: Dry needling with and without ultrasound guidance
Sponsor: University of Alcala
Sex: ALL
Age: ADULT
Enrollment: 76
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-23
Completion Date: 2025-03
Locations: Campus Científico-Tecnológico UAH Av. de León, 3A, Alcalá de Henares, Madrid, 28805, Spain

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

Primary Outcome Measures: 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 Outcome Measures: Shoulder functionality, To assess the shoulder functionality level, the Shoulder Pain and Disability Index (SPADI) questionnaire will be used. An 8-item block of questions, which addresses the disability the person feels when performing various activities, will be used to evaluate shoulder functionality. The patient will need to respond to the questions by assigning a number between 0 and 10, where 0 indicates no difficulty performing the activity and 10 represents the maximum possible difficulty in performing the activity., Before starting the treatment, at the end of the treatment, and six months after completing the treatment|Grip strength, To assess the grip strength variable, grip strength will be measured through an isotonic contraction using a Jamar dynamometer. Three measurements will be taken with the affected arm, asking for a contraction of 3 to 5 seconds. The highest score of the three measurements will be the final result of the test. A well-calibrated hand dynamometer must be used for this test. Kilograms (kg) will be used as the unit of measurement., Before starting the treatment, at the end of the treatment, and six months after completing the treatment|Active range of motion, The variable of active range of motion in the affected upper limb will be measured for flexion, abduction, internal rotation, and external rotation using a highly reliable electronic goniometer. Three measurements of each movement will be taken, and the final value will be obtained by averaging the three measurements., Before starting the treatment, at the end of the treatment, and six months after completing the treatment