Clinical trial NCT06987929: A Randomised Controlled Trial Comparing the Efficacy of Ultrasound-guided Hydrodilatation With Intra-articular Corticosteroid Injection in the Treatment of Adhesive Capsulitis.
Official title: A Randomised Controlled Trial Comparing the Efficacy of Ultrasound-guided Hydrodilatation With Intra-articular Corticosteroid Injection in the Treatment of Adhesive Capsulitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis, Shoulder
Keywords: Adhesive capsulitis, corticosteroid, hydrodilatation, interventional studies, intra-articular agents, pain assessment and management, ultrasonography
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-centre, prospective, open-label randomised controlled study (RCT)
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effectiveness of HD compared with intra-articular corticosteroid injection (IAI) in patients with adhesive capsulitis, with pain and function as the primary outcomes. We conducted a prospective, randomised controlled trial conducted in the Rheumatology department of a tertiary centre. Twenty patients with adhesive capsulitis were recruited and randomised equally to receive HD (n = 10), and IAI (n = 10). The primary outcome measures include Shoulder Pain and Disability Index (SPADI), QuickDASH questionnaire score, pain visual analogue scale (VAS) score, and range of motion (ROM) at 6-weeks post-intervention.

Detailed description: Adhesive capsulits is a common shoulder condition that causes significant pain and loss of joint mobility, thus affecting the quality of life. If left untreated, the symptoms can impair the person's function and persist for a longer duration. Both hydrodilatation and standard steroid injection into the glenohumeral joint are well recognised forms of treatment, but there is no consensus on the best treatment approach for adhesive capsulitis. Hydrodilatation involves injecting a larger volume of solution (with steroid and local anaesthetic mixed), into the space within the rotator cuff interval, leading to intra-articular distension of the joint capsule. The local anaesthetic used in the procedure provides immediate pain relief, while the long-term benefit comes from the resolution of the capsular stiffness and inflammation. This process stretches the capsule, resulting in adhesion breakdown and promoting the remodeling of the shoulder capsule, hence improving shoulder range of motion (ROM), especially in those with limited mobility due to the capsular tightening. This study aims to evaluate the effectiveness of HD compared with intra-articular corticosteroid injection (IAI) in patients with adhesive capsulitis, with pain and function as the primary outcomes. We conducted a prospective, randomised controlled trial conducted in the Rheumatology department of a tertiary centre. Twenty patients with adhesive capsulitis were recruited and randomised equally to receive HD (n = 10), and IAI (n = 10). The primary outcome measures include Shoulder Pain and Disability Index (SPADI), QuickDASH questionnaire score, pain visual analogue scale (VAS) score, and range of motion (ROM) at 6-weeks post-intervention.

Eligibility criteria: Inclusion Criteria:

1. adhesive capsulitis or frozen shoulder, diagnosed clinically, with or without imaging,
2. persistent symptoms of pain and restricted ROM for at least 3 months, despite conservative management with physiotherapy and/or analgesia

Exclusion Criteria:

1. previous surgery or shoulder implants of the affected shoulder,
2. history of recent trauma or fracture involving the affected shoulder,
3. age below 21 years,
4. pregnant women,
5. any evidence of ongoing active systemic inflammatory arthritis,
6. allergy to any of the injectates,
7. patients on anticoagulation (warfarin or direct oral anticoagulant),
8. received any joint injection in the past 6 months.

Primary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: 6 weeks
measure: QuickDASH score
timeFrame: 6 weeks
measure: Pain score
timeFrame: 6 weeks
measure: Active and passive range of motions (ROM):
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Autoimmunity and Rheumatology Centre
Study officials:
affiliation: Singapore General Hospital
name: Dr Chew Li Ching
role: PRINCIPAL_INVESTIGATOR
References: