Clinical Trials Logo

Clinical Trial Summary

Subacromial Impingement Syndrome (SIS) is a pathology resulting from mechanical repetitive compression and inflammation of the supraspinatus tendon, subacromial bursa and biceps tendon under the acromion and the coracoacromial ligament. It is the most common cause of shoulder pain, with an incidence of 44-65%. Restriction of the range of motion, along with the pain in the anterior region of the shoulder, is the main reason for disability and decreased quality of life in patients with SIS. Physical exercises to improve the range of motion, strengthening, and flexibility is the main part of treatment. The subacromial-subdeltoid bursa corticosteroid injection is shown to decrease pain during the exercise program and increase participation in the treatment. This study aims to compare the effectiveness of a supervised exercise program and home-based exercise program after subacromial-subdeltoid bursa corticosteroid injection in patients with SIS.


Clinical Trial Description

Subacromial Impingement Syndrome (SIS) is a pathology resulting from mechanical repetitive compression and inflammation of the supraspinatus tendon, subacromial bursa and biceps tendon under the acromion and the coracoacromial ligament. It was first described in 1972 by Neer. Neer described SIS as a progressive syndrome with three stages, beginning with chronic bursitis and proceeding to partial and complete tears of the supraspinatus tendon, which may extend to rupture of other parts of the rotator cuff and may also involve the long biceps tendon. SIS is one of the most common causes of shoulder pain and disability reasons in both primary and secondary care. It is characterized by functional impairment of shoulder resulted from the progressive limitation of both active and passive glenohumeral movements. Restriction of the range of motion (ROM) along with the pain in the anterior region of the shoulder that gets worse with arm elevation or overhead activities is the main reason for decreased quality of life in patients with SIS. Therapeutic exercise programs are commonly used treatment methods in relieving pain and improving ROM and muscle elasticity. It was shown that such programs are more effective in reducing pain and improving functional loss than placebo in both short- and long-term. However, the optimal exercise regimen with the variety, frequency, and intensity exercises is still unclear. It is also controversial if a supervised exercise program is superior to a prescribed home-based exercise program. An efficient exercise program should target all structures affected by subacromial impingement. Therefore, both supervised and home-based exercise programs must involve rotator cuff and scapular stabilizing muscle strengthening, stretching and active-assistive range of motion exercises and proprioceptive neuromuscular facilitation exercises. Corticosteroid injection into the subacromial-subdeltoid bursa is shown to increase participation, decrease pain during the exercise program, and found to be effective for symptomatic impingement. The analgesic effect provides significant improvement of functions mainly in the short-term. Therefore, some physicians prefer corticosteroid injections alone in the treatment of SIS. However, it was found that the combination of corticosteroid injection and exercise program is significantly superior to corticosteroid injections alone. Ultrasound-guided subacromial-subdeltoid bursa injections are shown to have better outcome results than blind injections for both pain and overall shoulder function. This study aims to compare the effectiveness of supervised exercise and home-based exercise programs after ultrasound-guided subacromial-subdeltoid bursa corticosteroid injection in patients with SIS.

Patients diagnosed with SIS will be included and randomized into two groups. Both groups will receive subacromial-subdeltoid bursa 1 ml (7 mg/ml) betamethasone and 4 ml of 0.5% bupivacaine injection. The injection will be performed ultrasound-guided while the patient is in a sitting position with the lateral approach. The first group will perform their exercises under the supervision of the physiotherapist in the hospital. The second group will be taken to the home-based exercise program in a brochure format. Thus, both groups will receive the same exercises every day.

The pain will be assessed with the Visual Analogue Scale (VAS), active and passive ROM will be measured with a goniometer before injection, immediately, first hour, third week, and third month after the injection. The quality of life will be evaluated by Short Form 36, and disability will be questioned by Shoulder Pain and Disability Index before injection and third week and third month after injection. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04186624
Study type Interventional
Source Marmara University
Contact
Status Completed
Phase N/A
Start date December 5, 2019
Completion date August 1, 2020

See also
  Status Clinical Trial Phase
Terminated NCT03913702 - Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement Phase 2
Completed NCT05071469 - Comparison of Two Different Treatment Methods N/A
Active, not recruiting NCT04660682 - A Comparison of the Long Term Effects of the Traditional and Modified Posterior Shoulder Stretching Exercise in Subacromial Impingement Syndrome N/A
Completed NCT03186287 - Effectiveness of Eccentric and Concentric Strength Training in Patients With Subacromial Impingement Syndrome N/A
Completed NCT04915430 - Training in Subacromial Impingement Syndrome N/A
Recruiting NCT01691157 - Exercise in the Physiotherapy Management of Shoulder Impingement N/A
Completed NCT01753271 - Subacute Effects of Spinal Mobilization to Treat Subacromial Impingement N/A
Withdrawn NCT01449448 - Subacromial Injection With Corticosteroid Versus Nonsteroidal Anti-inflammatory Drugs (NSAID) in Shoulder Impingement Syndrome N/A
Not yet recruiting NCT05794633 - Acupuncture Therapy in Patients With Subacromial Impingement Syndrome N/A
Active, not recruiting NCT06324487 - A New Application in Subacromial Impingement Syndrome N/A
Not yet recruiting NCT06023914 - Analysis of the Effect of Neuromuscular Electro-stimulation on the Performance of Isometric Rotator Cuff Strength. Phase 2/Phase 3
Recruiting NCT04644042 - The Effect of Arthroscopic Subacromial Decompression in Patients Who Are Non-responders to Non-operative Treatment. N/A
Completed NCT04594408 - Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery Phase 4
Completed NCT05549674 - Copenhagen Cohort of Patients With Shoulder Pain
Completed NCT03888586 - Comparison of Dry Needling and Deep Friction Massage in Patients With Subacromial Pain Syndrome N/A
Completed NCT03303001 - Comparison Between Subacromial Infiltrations N/A
Recruiting NCT03658707 - Validity and Reliability of the Turkish Version of the Functional Shoulder Score
Recruiting NCT02374125 - Teres Major Muscle and Subacromial Impingement Syndrome N/A
Active, not recruiting NCT03326466 - Muscle Function, Central Nervous System Sensitization, and Pain Profiling in Patients With Subacromial Pain (SAP-CNSS).
Completed NCT04169880 - Effects of High Intensity Laser Therapy (HILT) in Patients With Subacromial Impingement Syndrome N/A