Clinical trial NCT05977985: The Effects of Rotator Interval Hydro-dissection in Primary Adhesive Capsulitis.
Official title: The Effects of Rotator Interval Hydro-dissection in Primary Adhesive Capsulitis. A Two-arm Double-blind Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Adhesive Capsulitis of Shoulder
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Shoulder pain
timeFrame: 1 week, 4 weeks and 12 weeks post injection
Secondary outcomes:
measure: Shoulder range of motion
timeFrame: 4 weeks and 12 weeks post injection
measure: Shoulder function
timeFrame: 4 weeks and 12 weeks post injection
Other outcomes:
measure: Adverse events
timeFrame: from time to injection up till 1 week post injection
Locations:
Study officials:
References: