Acupuncture Therapy in Patients With Subacromial Impingement Syndrome

Not Applicable

Not yet recruiting

• Conditions: Acupuncture; Subacromial Impingement Syndrome

• Registration Number: NCT05794633
• Lead Sponsor: Fatih Sultan Mehmet Training and Research Hospital

Brief Summary

Shoulder pain is highly prevalent within general population, and shoulder impingement syndrome (SIS) is a common cause of shoulder pain. A small number of clinical and methodologically diverse trials have been published recently which show little evidence to support or refute the use of acupuncture for shoulder pain. Some researchers concluded, there is a need for further well-designed clinical trials. Our aim in this study is to investigate the effect of acupuncture treatment on pain, range of motion, functionality and quality of life in patients diagnosed with Subacromial Impingement Syndrome as a result of clinical and radiological tests.

Detailed Description

A randomized, prospective, double-blinded, placebo-controlled trial will be conducted. Patients diagnosed with shoulder impingement syndrome will be divided into two groups (acupuncture and placebo acupuncture) The evaluation will be performed at treatment initiation and at the end of the treatment and 1 month after treatment initiation.All patients will be evaluated by the same physiatrist who are blinded to the randomization process and treatment protocols.Primary outcome is pain which will be evaulated with visual analogue scale (VAS) for rest, activity, and sleep-disturbing. Secondary outcomes are shoulder range of motion in all groups will be evaluated with goniometer, shoulder function which will be evaulated with the Shoulder Pain and Disability Index (SPADI) and The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) and quality of life in all groups will be evaluated with The Western Ontario Rotator Cuff Index (WORC).

Study Timeline

• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-30
• Study First Posted: 2023-04-03
• Status Verified: 2023-09
• Study Start: 2023-09-12
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-14
• Primary Completion: 2023-11-20
• Study Completion: 2024-01-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Clinical diagnosis of Subacromial impingement syndrome
• Age range from 20-65 years
• Pain VAS ≥ 4
• Shoulder impingement symptoms lasting at least 6 weeks

Exclusion Criteria

• Presence of other shoulder pathologies
• Previous applications of physiotherapy and injection of hyaluronic acid and/or corticosteroid during the preceding 3 months;
• Presence of cervical pain or other conditions such as fibromyalgia confusing the clinical picture
• Presence of malignancy, blood disorder, neurologic, motor, and/or sensory deficit in the upper extremity;
• Pregnancy,
• Local anesthetic allergy
• Previous acupuncture treatment
• History of deformities, fractures, or surgery of the shoulder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain intensity	2 months	All groups will be evaluated for shoulder pain with visual analogue scale (VAS) for rest, activity, and sleep-disturbing.
Shoulder Pain and Disability Index	2 months	All groups will be evaluated for shoulder function with the Shoulder Pain and Disability Index (SPADI). SPADI:The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. To answer the questions, patients place a mark on a 10cm visual analogue scale for each question. Higher results indicate worse function.
The Disabilities of the Arm, Shoulder and Hand Score	2 months	All groups will be evaluated for shoulder function with The Disabilities of the Arm, Shoulder and Hand Score (QuickDash). The QuickDASH only contains 11 items. It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity/function level. Higher results indicate worse function.

Secondary Outcome Measures

Name	Time	Method
Quality of life index	2 months	Quality of life: All groups will be evaluated for quality of life with The Western Ontario Rotator Cuff Index (WORC). Each item in WORC has a possible score from 0-100 (100mm VAS). Scores can be computed for individual subscales and summated for a total score, which can range from 0-2100, with a higher score representing lower quality of life.
Shoulder range of motion	2 months	All groups will be evaluated for shoulder range of motion with goniometer.