The Effects of Rotator Interval Hydro-dissection in Primary Adhesive Capsulitis.

Study Overview
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Brief Summary
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Adhesive capsulitis (AC) is a significant cause of chronic shoulder pain and disability. Non-surgical option consisting of intraarticular corticosteroid (IA CS) injection with structured physiotherapy (PT) is the current standard of care. More recent randomized controlled trials have found that rotator interval (RI) hydro-dissection approach leads to better improvement in pain as compared to IA approach. Despite being non-inferior to surgical management, long-term outcome studies of patients treated with IA CS injection and PT have shown that patients only achieve satisfactory outcomes in 72.3% of patients after a mean symptom duration of 41.8 months. Furthermore, CS injections are associated with significant systemic and local adverse effects such as Cushing syndrome, osteopenia/ osteoporosis, infection, and hyperglycemia. In recent years, dextrose injection has emerged as an effective alternative to CS-based injections to treat chronic painful musculoskeletal conditions such as chronic low back pain, peripheral nerve entrapment and lateral epicondylitis. The investigators aim to study the effects of RI hydro-dissection with dextrose 5% (D5%) on pain relief, shoulder ROM and shoulder function in patients with primary AC.

Official Title
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The Effects of Rotator Interval Hydro-dissection in Primary Adhesive Capsulitis. A Two-arm Double-blind Randomised Controlled Trial

Conditions
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Adhesive Capsulitis of Shoulder

Intervention / Treatment
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* Drug: Rotator interval hydro-dissection with dextrose 5%
* Drug: Rotator interval hydro-dissection with corticosteroid solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with primary adhesive capsulitis aged 35 to 65 years of age duration of symptoms in between 3 to 18 months limitation in flexion, abduction, and external rotation greater than 30 degrees compared to normal limitation in internal rotation with hand to back shoulder test below L4 Exclusion Criteria: diagnosis of connective tissue disease or inflammatory arthritis history of surgery to the affected shoulder history of shoulder dislocation/ fracture neurological weakness of the affected upper limb ultrasound findings of rotator cuff or LHBT tendinopathy plain radiographs showing significant glenohumeral joint osteoarthritis (Kallgren-Lawrence grade 3 or 4) other sources of chronic pain bilateral adhesive capsulitis history of pain intervention to the shoulder joint in the past 3 months allergic reaction to local anesthetic agent

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dextrose 5%<br>Rotator interval hydro-dissection with dextrose 5% solution | Drug: Rotator interval hydro-dissection with dextrose 5%<br>* Single injection of 20ml dextrose 5% into the rotator interval around the long head biceps tendon under ultrasound guidance using a 11-14 Hz frequency linear probe<br>|
| Active Comparator: Corticosteroid<br>Rotator interval hydro-dissection with corticosteroid solution | Drug: Rotator interval hydro-dissection with corticosteroid solution<br>* Single injection of 20ml corticosteroid solution (1 ml triamcinolone 40 mg/ml + 19 ml saline 0.9%) into the rotator interval around the long head biceps tendon under ultrasound guidance using a 11-14 Hz frequency linear probe<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder pain | Shoulder pain based on Shoulder Pain and Disability Index (SPADI) pain scale. The SPADI pain scale ranges from 0 to 50, with higher score indicating greater level of pain. | 1 week, 4 weeks and 12 weeks post injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder range of motion | Shoulder range of motion in flexion, abduction, external rotation, internal rotation | 4 weeks and 12 weeks post injection | 
| Shoulder function | Shoulder function based on Shoulder Pain and Disability Index (SPADI) disability scale. The SPADI disability scale ranges from 0 to 80, with higher score indicating greater level of disability. | 4 weeks and 12 weeks post injection |