Adhesive Capsulitis of Shoulder
Conditions
Brief summary
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.
Interventions
DRUGRotator interval hydro-dissection with dextrose 5%
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
DRUGRotator interval hydro-dissection with corticosteroid solution
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
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder pain | 1 week, 4 weeks and 12 weeks post injection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder range of motion | 4 weeks and 12 weeks post injection | Shoulder range of motion in flexion, abduction, external rotation, internal rotation |
| Shoulder function | 4 weeks and 12 weeks post injection | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | from time to injection up till 1 week post injection | Adverse events during or after injection |
Contacts
Primary ContactRichard Teo
Outcome results
None listed