Corticosteroid Injection Versus Tendon Dry Needling for Subacromial Impingement Syndrome

NCT05882786 | Unknown

• 1 other identifier: ImpDn1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Shoulder Pain; Shoulder Impingement Syndrome; Shoulder Impingement; Subacromial Impingement Syndrome; Subacromial Impingement

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

The corticosteroid (Triamcinolone Acetonide) injection group

ACTIVE COMPARATOR

Participants in this group will receive a single subacromial injection of 40mg triamcinolone acetonide.

Procedure: Corticosteroid injection

Tendon dry needling group

ACTIVE COMPARATOR

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

Interventions

Corticosteroid injection PROCEDURE

Subacromial injection of 40mg triamcinolone acetonide.

The corticosteroid (Triamcinolone Acetonide) injection group

Dry Needling PROCEDURE

Dry needling treatment to the supraspinatus, infraspinatus, and subscapularis muscles tendons.

Tendon dry needling group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uskudar State Hospital: lead

MeSH Terms

Conditions

Shoulder Pain; Shoulder Impingement Syndrome

Interventions

Adrenal Cortex Hormones; Dry Needling

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Mustafa H Temel, M.D.

  Uskudar State Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa H Temel, M.D.

CONTACT

+905342714872; mhuseyintemel@gmail.com

Fatih Bağcıer, M.D.

CONTACT

05442429042; bagcier_42@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: May 31, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 1 month.
• Access Criteria: Individual participant data will be shared upon reasonable request by the corresponding author.