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

• ClinicalTrials.gov Identifier: NCT05977985
• Recruitment Status: Not yet recruiting
• First Posted: August 7, 2023
• Last Update Posted: August 7, 2023
• Sponsor: University of Malaya
• Information provided by (Responsible Party): University of Malaya

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Adhesive Capsulitis of Shoulder	Drug: Rotator interval hydro-dissection with dextrose 5%; Drug: Rotator interval hydro-dissection with corticosteroid solution	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effects of Rotator Interval Hydro-dissection in Primary Adhesive Capsulitis. A Two-arm Double-blind Randomised Controlled Trial
• Estimated Study Start Date: August 1, 2023
• Estimated Primary Completion Date: July 1, 2024
• Estimated Study Completion Date: July 1, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dextrose 5%; Rotator interval hydro-dissection with dextrose 5% solution	Drug: 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
Active Comparator: Corticosteroid; Rotator interval hydro-dissection with corticosteroid solution	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

Outcome Measures

Primary Outcome Measures :

1. Shoulder pain [ Time Frame: 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 :

1. Shoulder range of motion [ Time Frame: 4 weeks and 12 weeks post injection ]
   Shoulder range of motion in flexion, abduction, external rotation, internal rotation
2. Shoulder function [ Time Frame: 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 Outcome Measures:

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

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Richard Teo; richardskteo@ummc.edu.my

Sponsors and Collaborators

University of Malaya

More Information

• Responsible Party: University of Malaya
• ClinicalTrials.gov Identifier: NCT05977985
• Other Study ID Numbers: 2023630-12612
• First Posted: August 7, 2023
• Last Update Posted: August 7, 2023
• Last Verified: July 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Bursitis; Joint Diseases; Musculoskeletal Diseases