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

NCT05977985 | Unknown Phase 4

• 1 other identifier: 2023630-12612
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Shoulder pain

  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.

  1 week, 4 weeks and 12 weeks post injection

Secondary Outcomes (2)

• Shoulder range of motion

  4 weeks and 12 weeks post injection

• Shoulder function

  4 weeks and 12 weeks post injection

Other Outcomes (1)

• Adverse events

  from time to injection up till 1 week post injection

Study Arms (2)

Dextrose 5%

EXPERIMENTAL

Rotator interval hydro-dissection with dextrose 5% solution

Drug: Rotator interval hydro-dissection with dextrose 5%

Corticosteroid

ACTIVE COMPARATOR

Rotator interval hydro-dissection with corticosteroid solution

Drug: Rotator interval hydro-dissection with corticosteroid solution

Interventions

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

Dextrose 5%

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

Corticosteroid

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Central Study Contacts

Richard Teo

CONTACT

richardskteo@ummc.edu.my

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 7, 2023
• Study Start: August 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: August 7, 2023

Record last verified: 2023-07