Clinical trial NCT04186624: Effectiveness of Supervised Exercise Program in Subacromial Impingement Syndrome
Official title: Effectiveness of Supervised Exercise Program After Subacromial- Subdeltoid Bursitis Injection in Subacromial Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Impingement Syndrome
Keywords: Subacromial Impingement Syndrome
Subacromial-subdeltoid bursa corticosteroid injection
Exercise Therapy
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This randomized controlled study is designed to have two groups with a single arm.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Symptoms lasting longer than 3 months
2. Aged between 20-60 years
3. The diagnosis is made by the clinician and detected by MRI

Exclusion Criteria:

1. History of physical therapy or injection in the last 3 months
2. Shoulder fracture history
3. Presence of Type III (hooked) acromion
4. Complete rupture of the rotator cuff muscles
5. Presence of instability problem in shoulder
6. History of shoulder surgery
7. History of inflammatory rheumatoid disease
8. Uncontrolled diabetes mellitus
9. Allergy to steroids or local anesthetics (drug hypersensitivity)
10. Known contraindications for interventional procedures (infection at the injection site, coagulopathy, etc.)

Primary outcomes:
measure: Pain and tightness sensation
timeFrame: before treatment (T0)
measure: Pain and tightness sensation
timeFrame: 1st hour after injection (T1)
measure: Pain and tightness sensation
timeFrame: 3rd week of treatment (T2)
measure: Pain and tightness sensation
timeFrame: 3rd month of treatment (T3)
Secondary outcomes:
measure: Pain and Disability - SPADI
timeFrame: before treatment (T0)
measure: Pain and Disability - SPADI
timeFrame: 3rd week of treatment (T1)
measure: Pain and Disability - SPADI
timeFrame: 3rd month of treatment (T2)
measure: Quality of life- Short Form-36
timeFrame: before treatment (T0)
measure: Quality of life- Short Form-36
timeFrame: 3rd week of treatment (T1)
measure: Quality of life- Short Form-36
timeFrame: 3rd month of treatment (T2)
measure: Shoulder range of motion (ROM) will be evaluated with a goniometer
timeFrame: before treatment (T0)
measure: Shoulder range of motion (ROM) will be evaluated with a goniometer
timeFrame: 1st hour after injection (T1)
measure: Shoulder range of motion (ROM) will be evaluated with a goniometer
timeFrame: 3rd week of treatment (T2)
measure: Shoulder range of motion (ROM) will be evaluated with a goniometer
timeFrame: 3rd month of treatment (T3)
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Marmara University
name: İlker Yağcı, Prof
role: STUDY_CHAIR
affiliation: Marmara University
name: Ebru Kaplan, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pieters L, Lewis J, Kuppens K, Jochems J, Bruijstens T, Joossens L, Struyf F. An Update of Systematic Reviews Examining the Effectiveness of Conservative Physical Therapy Interventions for Subacromial Shoulder Pain. J Orthop Sports Phys Ther. 2020 Mar;50(3):131-141. doi: 10.2519/jospt.2020.8498. Epub 2019 Nov 15.
citation: Granviken F, Vasseljen O. Home exercises and supervised exercises are similarly effective for people with subacromial impingement: a randomised trial. J Physiother. 2015 Jul;61(3):135-41. doi: 10.1016/j.jphys.2015.05.014. Epub 2015 Jun 18.
citation: Steuri R, Sattelmayer M, Elsig S, Kolly C, Tal A, Taeymans J, Hilfiker R. Effectiveness of conservative interventions including exercise, manual therapy and medical management in adults with shoulder impingement: a systematic review and meta-analysis of RCTs. Br J Sports Med. 2017 Sep;51(18):1340-1347. doi: 10.1136/bjsports-2016-096515. Epub 2017 Jun 19.
citation: Burger M, Africa C, Droomer K, Norman A, Pheiffe C, Gericke A, Samsodien A, Miszewski N. Effect of corticosteroid injections versus physiotherapy on pain, shoulder range of motion and shoulder function in patients with subacromial impingement syndrome: A systematic review and meta-analysis. S Afr J Physiother. 2016 Sep 27;72(1):318. doi: 10.4102/sajp.v72i1.318. eCollection 2016.
citation: Kromer TO, de Bie RA, Bastiaenen CH. Effectiveness of physiotherapy and costs in patients with clinical signs of shoulder impingement syndrome: One-year follow-up of a randomized controlled trial. J Rehabil Med. 2014 Nov;46(10):1029-36. doi: 10.2340/16501977-1867.