Real Dry Needling and Placebo Dry Needling Applied With and Without Ultrasound Guidance on the Infraspinatus Muscle (DN-INFR-RCT)

September 3, 2024 updated by: Enrique Coca, University of Alcala

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Madrid
      • Alcalá de Henares, Madrid, Spain, 28805
        • Campus Científico-Tecnológico UAH Av. de León, 3A
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

-

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Sham Comparator: 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.
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.
Active Comparator: 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
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.
Sham Comparator: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain (VAS)
Time Frame: Before starting the treatment, at the end of the treatment, and six months after completing the treatment
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

Outcome Measure
Measure Description
Time Frame
Shoulder functionality
Time Frame: Before starting the treatment, at the end of the treatment, and six months after completing the treatment
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
Time Frame: Before starting the treatment, at the end of the treatment, and six months after completing the treatment
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
Time Frame: Before starting the treatment, at the end of the treatment, and six months after completing the treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alcala

Investigators

  • Principal Investigator: Enrique Coca, Student, University of Alcalá

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 23, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

September 1, 2024

First Submitted That Met QC Criteria

September 3, 2024

First Posted (Actual)

September 4, 2024

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

September 3, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dry Needling Infraspinatus

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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