Acupuncture Therapy in Patients With Subacromial Impingement Syndrome

Fatih Sultan Mehmet Training and Research Hospital

Status: Not yet enrolling

Conditions: Acupuncture; Subacromial Impingement Syndrome

Treatments: Other: Placebo acupuncture; Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05794633

KAEK-2012-70

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Acupuncture Group

Experimental group

Description:

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

Treatment:

Other: Acupuncture

Placebo Acupuncture Group

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo acupuncture