NCT05794633

Acupuncture Therapy in Patients With Subacromial Impingement Syndrome

Effectiveness of Acupuncture Therapy in Patients With Subacromial Impingement Syndrome, Randomized Placebo-controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Fatih Sultan Mehmet Training and Research Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Acupuncture
• Subacromial Impingement Syndrome

Interventions

Type	Name	Description
OTHER	Acupuncture	The patients will be recieved two days a week for 8 sessions with sterile 25\*40 mm needles.Selected points are as local points, 2 painful points (ahshi point) in the shoulder region, Large intestine 4, 15, Gallbladder 21, Triple warmer 5, 14 Small intestine 9; as distant points Gallbladder 34 and Stomach 38. Patients will recieve also exercise treatment for 8 weeks and coldpack for 4 weeks
OTHER	Placebo acupuncture	The patients will be recieved two days a week for 8 sessions with placebo needle. Selected points are Large intestine 15 Triple warmer 14 gallbladder 21 and small intestine 9. We will use the placebo needle (blunt needle, tip obtuse, when acupuncture the feeling is similar to acupuncture needles into the skin, but it retracts instead of piercing the skin) to conduct acupuncture treatment. The retention time will be the same as those in the acupuncture group. The specialist will give the subjects verbal cues before and during the acupuncture manipulation, which further reduces the subjects' doubts about the authenticity of acupuncture in the this group. To ensure the implementation of the blinding method, all patients will be treated independently and avoid contacting with each other. Patients will recieve also exercise treatment for 8 weeks and coldpack for 4 weeks

Timeline

• Start date: 2023-09-12
• Primary completion: 2023-11-20
• Completion: 2024-01-20
• First posted: 2023-04-03
• Last updated: 2023-09-14