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

NCT ID: NCT05977985

Last Updated: 2023-08-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-07-01

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.

Conditions

Adhesive Capsulitis of Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dextrose 5%

Rotator interval hydro-dissection with dextrose 5% solution

Group Type: EXPERIMENTAL

Rotator interval hydro-dissection with dextrose 5%

Intervention Type: 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

Corticosteroid

Rotator interval hydro-dissection with corticosteroid solution

Group Type: ACTIVE_COMPARATOR

Rotator interval hydro-dissection with corticosteroid solution

Intervention Type: 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

Interventions

Rotator 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

Intervention Type: DRUG

Rotator 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Malaya

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Richard Teo

Role: CONTACT

richardskteo@ummc.edu.my

Other Identifiers

2023630-12612

Identifier Type: -

Identifier Source: org_study_id