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

NCT05977985 — Phase 4, Unknown, 60 participants, University of Malaya

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

Registry	NCT05977985
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	60 (Estimated)
Sponsor	University of Malaya (Other)
Conditions	Adhesive Capsulitis of Shoulder
Interventions	Rotator interval hydro-dissection with dextrose 5%, Rotator interval hydro-dissection with corticosteroid solution (Drug)
Dates	start 2023-08-01 (estimated), primary completion 2024-07-01 (estimated), completion 2025-07-01 (estimated), first posted 2023-08-07, last updated 2023-08-07

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Dextrose 5%	Experimental	Drug: Rotator interval hydro-dissection with dextrose 5%	Rotator interval hydro-dissection with dextrose 5% solution
Corticosteroid	Active comparator	Drug: Rotator interval hydro-dissection with corticosteroid solution	Rotator interval hydro-dissection with corticosteroid solution

Rotator interval hydro-dissection with dextrose 5% (Drug): 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
Rotator interval hydro-dissection with corticosteroid solution (Drug): 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

+Outcome measures

Primary outcomes

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 outcomes

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 outcomes

Adverse events [from time to injection up till 1 week post injection]: Adverse events during or after injection

+Eligibility

Sex: All, ages: 35 Years to 65 Years, accepts healthy volunteers

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