Isolated Glenohumeral Corticosteroid Injection Versus Concomitant Capsule Preserving Hydrodilatation
- Conditions
- Adhesive CapsulitisAdhesive Capsulitis of Shoulder
- Interventions
- Procedure: Ultrasound-guided glenohumeral space concomitant hydrodilatation with corticosteroid injectionProcedure: Ultrasound-guided glenohumeral space isolated corticosteroid injectionDrug: 4mL of Lidocaine 1% Solution Injectable SolutionDrug: 15mL of Normal Saline
- Registration Number
- NCT06493656
- Lead Sponsor
- Chuncheon Sacred Heart Hospital
- Brief Summary
This clinical trial investigates whether concomitant capsule-preserving hydrodilatation (CSHD) is more effective than isolated glenohumeral corticosteroid injection (CS) in treating shoulder adhesive capsulitis. The main questions it aims to answer are
* Is CSHD inferior to CS in immediate pain relief as the solution is diluted?
* Is CSHD superior to CS in improving the range of motion as the contracted capsule is dilated?
Group CS will receive an ultrasound-guided glenohumeral corticosteroid injection only, with a solution of 5 mL.
Group CSHD will receive an ultrasound-guided glenohumeral corticosteroid with hydrodilatation, with a solution of 20 mL.
Clinical scores and range of motion will be compared between the groups up to six months post-injection.
- Detailed Description
A single-centre, double-blinded, prospective randomised controlled trial involving patients diagnosed with adhesive capsulitis of the shoulder (AC).
Patients were randomly allocated to either corticosteroid injection with hydrodilatation (group CSHD) or corticosteroid injection only (group CS).
For the CS group, a solution of 1 mL triamcinolone (40mg) and 4 mL 1% lidocaine, 5 mL in total, was injected intraarticularly through the posterior approach using ultrasound guidance.
The CSHD group received an injection of 20 mL with 15 mL of normal saline added to the abovementioned 5 mL solution. The dilatation of the joint capsule was confirmed by the increase in distance between the capsule and the humeral head.
Patients underwent the following assessments just before the injection, and at post-injection three weeks, seven weeks, three months, and six months.
Range of motion in forward elevation, external rotation, and internal rotation Clinical scores include the pain visual analogue scale (pVAS), the American Shoulder and Elbow Surgeons score, and the Constant-Murley score.
Subjective patient satisfaction was recorded on a scale from 0 to 100, with 100 being the most satisfied.
The recorded data were compared within each group before and after the injection, and also between the groups.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Two or more of the following criteria within the shoulder's range of motion:
- Abduction and forward elevation below 100˚
- External rotation at the side below 30˚
- Internal rotation at 90˚ of abduction below 30˚
- History of shoulder surgery, trauma, nerve injury
- Concomitant rotator cuff/biceps lesions in ultrasound or MRI
- Glenohumeral arthritis in simple X-ray
- Calcific tendinosis in simple X-ray
- Underlying conditions: cancer, mental illness, hormonal imbalance
- Diabetes with HbA1c levels exceeding 7.0%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Concomitant hydrodilatation with corticosteroid injection Ultrasound-guided glenohumeral space concomitant hydrodilatation with corticosteroid injection Ultrasound-guided posterior approach of glenohumeral space hydrodilatation for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, and 15 mL normal saline Concomitant hydrodilatation with corticosteroid injection 15mL of Normal Saline Ultrasound-guided posterior approach of glenohumeral space hydrodilatation for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, and 15 mL normal saline Isolated corticosteroid injection 1mL of Triamcinolone (40mg/1mL) Injectable Solution Ultrasound-guided posterior approach of glenohumeral space injection for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine. Isolated corticosteroid injection 4mL of Lidocaine 1% Solution Injectable Solution Ultrasound-guided posterior approach of glenohumeral space injection for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine. Isolated corticosteroid injection Ultrasound-guided glenohumeral space isolated corticosteroid injection Ultrasound-guided posterior approach of glenohumeral space injection for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine. Concomitant hydrodilatation with corticosteroid injection 1mL of Triamcinolone (40mg/1mL) Injectable Solution Ultrasound-guided posterior approach of glenohumeral space hydrodilatation for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, and 15 mL normal saline Concomitant hydrodilatation with corticosteroid injection 4mL of Lidocaine 1% Solution Injectable Solution Ultrasound-guided posterior approach of glenohumeral space hydrodilatation for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, and 15 mL normal saline
- Primary Outcome Measures
Name Time Method Visual analog scale (VAS) for pain Change from the baseline to 6 months Patient-reported 0-10 scale of pain, 0: no pain, 10: very severe pain
- Secondary Outcome Measures
Name Time Method American Shoulder and Elbow Surgeons (ASES) shoulder score Change from the baseline to 6 months Patient-reported shoulder satisfaction score, 0-100, higher scores mean a better outcome.
Constant-Murley score Change from the baseline to 6 months Patient-reported and healthcare provider-assessed shoulder satisfaction score, 0-100, higher scores mean a better outcome.
Range of motion (ROM) Change from the baseline to 6 months ROM in degrees, forward elevation (0-150), external rotation (0-90), and internal rotation (0-90)
Trial Locations
- Locations (1)
Chuncheon Sacred Heart Hospital
🇰🇷Chuncheon, Gangwondo, Korea, Republic of