Corticosteroid Injection Versus Tendon Dry Needling for Subacromial Impingement Syndrome

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05882786
• Other study ID #: ImpDn1
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: May 2023
• Source: Uskudar State Hospital
• Contact: Mustafa H Temel, M.D.
• Phone: +905342714872
• Email: mhuseyintemel[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Shoulder Impingement
• Shoulder Impingement Syndrome
• Shoulder Pain
• Subacromial Impingement
• Subacromial Impingement Syndrome
• Syndrome

Intervention

Procedure:
• Corticosteroid injection
Subacromial injection of 40mg triamcinolone acetonide.
• Dry Needling
Dry needling treatment to the supraspinatus, infraspinatus, and subscapularis muscles tendons.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Uskudar State Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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