Clinical trial NCT05794633: Acupuncture Therapy in Patients With Subacromial Impingement Syndrome
Official title: Effectiveness of Acupuncture Therapy in Patients With Subacromial Impingement Syndrome, Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acupuncture
Subacromial Impingement Syndrome
Lead sponsor: Fatih Sultan Mehmet Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo-controlled trial
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity
timeFrame: 2 months
measure: Shoulder Pain and Disability Index
timeFrame: 2 months
measure: The Disabilities of the Arm, Shoulder and Hand Score
timeFrame: 2 months
Secondary outcomes:
measure: Shoulder range of motion
timeFrame: 2 months
measure: Quality of life index
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Fatih Sultan Mehmet Traning and Research Hospital
name: Duygu Silte Karamanlioglu
role: PRINCIPAL_INVESTIGATOR
affiliation: Fatih Sultan Mehmet Traning and Research Hospital
name: Meryem Yilmaz Kaysin
role: STUDY_CHAIR
affiliation: Fatih Sultan Mehmet Traning and Research Hospital
name: Feyza Akan Begoglu
role: STUDY_CHAIR
affiliation: Fatih Sultan Mehmet Traning and Research Hospital
name: Pinar Akpinar
role: STUDY_CHAIR
affiliation: Fatih Sultan Mehmet Traning and Research Hospital
name: Feyza Unlu Ozkan
role: STUDY_CHAIR
affiliation: Fatih Sultan Mehmet Traning and Research Hospital
name: Ilknur Aktas
role: STUDY_CHAIR
References: