A Randomised Controlled Trial Comparing the Efficacy of Ultrasound-guided Hydrodilatation With Intra-articular Corticosteroid Injection in the Treatment of Adhesive Capsulitis.

NCT06987929 | Completed

• 1 other identifier: 2022/2474
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesive Capsulitis, Shoulder

Keywords

Adhesive capsulitis, corticosteroid, hydrodilatation, interventional studies, intra-articular agents, pain assessment and management, ultrasonography

Outcome Measures

Primary Outcomes (4)

• Shoulder Pain and Disability Index (SPADI)

  SPADI: self-reported questionnaire by patient on pain and disability.

  6 weeks

• QuickDASH score

  self-reported questionnaire by patient on upper extremity disability

  6 weeks

• Pain score

  self-reported by patient using visual analogue scale (VAS).

  6 weeks

• Active and passive range of motions (ROM):

  measured by investigators blinded to the treatments.

  6 weeks

Study Arms (2)

Conventional Group

OTHER

Procedure: Intra-articular steroid injection (IAI)

Hydrodilation

ACTIVE COMPARATOR

Procedure: Hydrodilatation injection

Interventions

Hydrodilatation injection PROCEDURE

During the procedure, the patient lie supine on an examination couch, with the affected arm in the modified Crass position. All injections were done under image guidance using a Philips EPIQ ultrasound machine with an L18-12 MHz linear array transducer, performed consecutively by 2 rheumatologists or 1 pain medicine anaesthetist, all trained in MSK US. Aseptic technique was used. The transducer was placed at the short axis of the supraspinatus tendon, and the rotator cuff interval and coracohumeral ligament (CHL) were identified. Local anaesthetic (1% lignocaine) was injected subcutaneously to the skin. The therapeutic medication consisted of a mixture of 40 mg triamcinolone (10 mg/ml concentration) and 5ml 1% lignocaine, which was diluted with sterile normal saline into a total of 20mls suspension. The injection was administered using a 22-G 2-inch needle (Stimuplex A) introduced below the CHL adjacent to the long head of biceps tendon, in the in-plane view under US guidance.

Hydrodilation

Intra-articular steroid injection (IAI) PROCEDURE

Intra-articular corticosteroid injection was performed as a control group. The posterior shoulder approach was used. The patient was positioned in the lateral decubitus or semi-prone position with the affected shoulder at the uppermost position, elbow semi-flexed and the ipsilateral arm resting on a pillow for comfort and stability. The ultrasound transducer is positioned over the long axis of the myotendinous junction of the infraspinatous tendon to view the contours of the posterior glenoid labrum and posterior portion of the humeral head. The injectate was administered using a 21-G hypodermic needle. 40 mg triamcinolone (10 mg/ml concentration) mixed with 1ml of 1% lignocaine was injected into the posterior glenohumeral joint, under ultrasound-guidance. Any adverse reaction that occurred during the procedure was recorded. Following the procedure, the patient was advised to avoid overuse of the injected joint for 24 hours as part of post-injection care.

Conventional Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Autoimmunity and Rheumatology Centre

Singapore, 169608, Singapore

Location

MeSH Terms

Conditions

Bursitis

Interventions

Steroids

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Dr Chew Li Ching

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-centre, prospective, open-label randomised controlled study (RCT)

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: December 12, 2022
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)