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

Phase 4

Not yet recruiting

• Conditions: Adhesive Capsulitis of Shoulder
• Interventions: Drug: Rotator interval hydro-dissection with corticosteroid solution; Drug: Rotator interval hydro-dissection with dextrose 5%

• Registration Number: NCT05977985
• Lead Sponsor: University of Malaya

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-19
• Study Start: 2023-08-01
• Study First Submitted QC: 2023-08-02
• Last Update Submitted: 2023-08-02
• Study First Posted: 2023-08-07
• Last Update Posted: 2023-08-07
• Primary Completion: 2024-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corticosteroid	Rotator interval hydro-dissection with corticosteroid solution	Rotator interval hydro-dissection with corticosteroid solution
Dextrose 5%	Rotator interval hydro-dissection with dextrose 5%	Rotator interval hydro-dissection with dextrose 5% solution

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.