Adhesive Capsulitis, Adhesive Capsulitis of Shoulder
Conditions
Keywords
Glenohumeral injection, Hydrodilatation, Corticosteroid injection
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.
Interventions
PROCEDUREUltrasound-guided glenohumeral space isolated corticosteroid injection
Using a 21-gauge spinal needle, the predefined steroid solution was injected under ultrasound guidance using 5- to 13-MHz linear probe into the glenohumeral space through the posterior approach.
PROCEDUREUltrasound-guided glenohumeral space concomitant hydrodilatation with corticosteroid injection
Using a 21-gauge spinal needle, the predefined steroid solution with additional 15 mL of normal saline was injected under ultrasound guidance using 5- to 13-MHz linear probe into the glenohumeral space through the posterior approach.
DRUG1mL of Triamcinolone (40mg/1mL) Injectable Solution
1mL of Triamcinolone 40mg/1mL solution was included in the injection/hydrodilatation regimen.
DRUG4mL of Lidocaine 1% Solution Injectable Solution
4mL of 1% Lidocaine solution was included in the injection/hydrodilatation regimen.
DRUG15mL of Normal Saline
15mL of 1% Lidocaine solution was included in the hydrodilatation regimen.
Sponsors
Chuncheon Sacred Heart Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
A final number of 50 patients were enrolled in the trial and randomly assigned to either the isolated corticosteroid injection group (Group CS) or the concomitant hydrodilatation group (Group CSHD). Double-blinded randomization was performed by an independent nurse using a computer-generated random sequence. A musculoskeletal radiologist, blinded to group allocation, performed the diagnostic ultrasound and MRI interpretations. A blinded orthopaedic nurse carried out the physical examination and clinical scoring.
Intervention model description
Study group underwent ultrasound-guided posterior approach of glenohumeral space injection for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 7 mL normal saline. Control group underwent ultrasound-guided posterior approach of glenohumeral space HYDRODILATATION for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 15 mL normal saline.
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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˚
Exclusion criteria
* 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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons (ASES) shoulder score | Change from the baseline to 7 weeks | Patient-reported shoulder satisfaction score, 0-100, higher scores mean a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORJung Taek Hwang, MD, PhD
Chuncheon Sacred Heart Hospital
Outcome results
None listed