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

University of Malaya

Status and phase: Not yet enrolling; Phase 4

Conditions: Adhesive Capsulitis of Shoulder

Treatments: Drug: Rotator interval hydro-dissection with dextrose 5%; Drug: Rotator interval hydro-dissection with corticosteroid solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05977985

2023630-12612

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Dextrose 5%

Experimental group

Description:

Rotator interval hydro-dissection with dextrose 5% solution

Treatment:

Drug: Rotator interval hydro-dissection with dextrose 5%

Corticosteroid

Active Comparator group

Description:

Rotator interval hydro-dissection with corticosteroid solution

Treatment:

Drug: Rotator interval hydro-dissection with corticosteroid solution