Corticosteroid Injection Versus Tendon Dry Needling for Subacromial Impingement Syndrome

Comparing the Efficacy of Corticosteroid Injection and Tendon Dry Needling for Subacromial Impingement Syndrome: A Randomized Clinical Trial

This randomized clinical trial aims to compare the efficacy of corticosteroid injection and tendon dry needling for the treatment of subacromial impingement syndrome.

Study Overview

• Status: Not yet recruiting
• Conditions: Subacromial Impingement Syndrome; Shoulder Impingement Syndrome; Shoulder Pain; Subacromial Impingement; Shoulder Impingement
• Intervention / Treatment: Procedure: Corticosteroid injection; Procedure: Dry Needling

Detailed Description

This randomized clinical trial will compare the efficacy of corticosteroid injection and tendon dry needling for the treatment of subacromial impingement syndrome.Participants will be randomized to receive either a corticosteroid injection or tendon dry needling treatment. The corticosteroid injection group will receive a single subacromial injection of 40mg triamcinolone acetonide under ultrasound guidance. The tendon dry needling group will receive a total of 3 sessions of dry needling treatment to the supraspinatus, infraspinatus, and subscapularis muscle tendons. Patients will be assessed before treatment, after treatment, after three weeks and after three months with visual analog scale, Shoulder Pain and Disability Index (SPADI) and shoulder range of motion measurements.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mustafa H Temel, M.D.; Phone Number: +905342714872; Email: mhuseyintemel@gmail.com
• Study Contact Backup: Name: Fatih Bağcıer, M.D.; Phone Number: 05442429042; Email: bagcier_42@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients aged 18-65 years old
• Diagnosis of subacromial impingement syndrome, confirmed by clinical examination and imaging (such as X-ray or MRI)
• Moderate to severe shoulder pain, with a score of at least 4 on a 0-10 visual analog scale (VAS) for pain
• Willingness to comply with the study protocol and attend all study visits and assessments
• Ability to provide informed consent to participate in the study.

Exclusion Criteria:

• Contraindications to corticosteroid injection or dry needling, such as local infection, bleeding disorders, or allergy to the injectate or needle
• Previous shoulder surgery on the affected shoulder
• Other active shoulder conditions, such as rotator cuff tear or adhesive capsulitis, that may confound the study results
• Systemic conditions, such as rheumatoid arthritis or osteoarthritis, that may affect the shoulder joint and its function
• History of shoulder dislocation or instability
• Pregnancy or breastfeeding
• Current use of systemic corticosteroids or immunosuppressive drugs
• Injection to shoulder area in the past six months.
• Inability to complete the study assessments or follow the study protocol, such as due to cognitive impairment or language barrier.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: The corticosteroid (Triamcinolone Acetonide) injection group; Participants in this group will receive a single subacromial injection of 40mg triamcinolone acetonide.	Procedure: Corticosteroid injection; Subacromial injection of 40mg triamcinolone acetonide.
Active Comparator: Tendon dry needling group; Participants in this group will receive a total of 3 sessions of dry needling treatment to the supraspinatus, infraspinatus, and subscapularis muscle tendons.	Procedure: Dry Needling; Dry needling treatment to the supraspinatus, infraspinatus, and subscapularis muscles tendons.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analog Scale for Pain	A Visual Analog Scale (VAS) for pain is a commonly used tool to measure the intensity of pain experienced by a patient. It typically consists of a horizontal or vertical line, typically 10 centimeters long, with endpoints labeled as "no pain" and "worst possible pain." The patient is asked to mark on the line the point that best represents the intensity of their pain, with the distance from the "no pain" end of the line to the patient's mark representing the pain score.	First day, after three weeks, after three months
Change in The Shoulder Pain and Disability Index (SPADI)	The Shoulder Pain and Disability Index (SPADI) is a validated patient-reported outcome measure that is commonly used to assess pain and functional disability related to shoulder disorders. The SPADI consists of 13 items that assess pain and disability in two domains: 1) pain and 2) disability. The pain domain consists of five items that assess the intensity and frequency of shoulder pain, while the disability domain consists of eight items that assess the impact of shoulder pain on daily activities such as sleeping, dressing, and carrying objects.	First day, after three weeks, after three months
Change in Range Of Motion (ROM) Measurements	ROM of the shoulder joint is typically assessed using a goniometer, a device that measures joint angles. The goniometer is used to measure the degree of movement in different directions, including flexion, extension, abduction, adduction, internal rotation, and external rotation. The measurements obtained from the goniometer can then be used to determine the improvement or deterioration in ROM over time, which can be an indicator of treatment efficacy.	First day, after three weeks, after three months

Collaborators and Investigators

• Sponsor: Uskudar State Hospital
• Investigators: Principal Investigator: Mustafa H Temel, M.D., Üsküdar State Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: May 7, 2023
• First Submitted That Met QC Criteria: May 20, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 20, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Arthralgia; Syndrome; Rotator Cuff Injuries; Shoulder Impingement Syndrome; Shoulder Pain
• Other Study ID Numbers: ImpDn1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be shared upon reasonable request by the corresponding author.
• IPD Sharing Time Frame: 1 month.
• IPD Sharing Access Criteria: Individual participant data will be shared upon reasonable request by the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No