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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
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.
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.
1mL of Triamcinolone 40mg/1mL solution was included in the injection/hydrodilatation regimen.
4mL of 1% Lidocaine solution was included in the injection/hydrodilatation regimen.
15mL of 1% Lidocaine solution was included in the hydrodilatation regimen.
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwondo, South Korea
Visual analog scale (VAS) for pain
Patient-reported 0-10 scale of pain, 0: no pain, 10: very severe pain
Time frame: Change from the baseline to 6 months
Range of motion (ROM)
ROM in degrees, forward elevation (0-150), external rotation (0-90), and internal rotation (0-90)
Time frame: Change from the baseline to 6 months
American Shoulder and Elbow Surgeons (ASES) shoulder score
Patient-reported shoulder satisfaction score, 0-100, higher scores mean a better outcome.
Time frame: Change from the baseline to 6 months
Constant-Murley score
Patient-reported and healthcare provider-assessed shoulder satisfaction score, 0-100, higher scores mean a better outcome.
Time frame: Change from the baseline to 6 months
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