Chuncheon Sacred Heart Hospital
Chuncheon, Gangwondo, 700-204, South Korea
NCT Number: NCT06493656
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.
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Notify Me35 year–80 year
All sexes
Interventional
Not applicable
Chuncheon, Gangwondo, 700-204, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Two or more of the following criteria within the shoulder's range of motion:
Exclusion criteria
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.
Time frame: Change from the baseline to 7 weeks
Patient-reported shoulder satisfaction score, 0-100, higher scores mean a better outcome.
Time frame: Change from the baseline to 6 months
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
Patient-reported 0-10 scale of pain, 0: no pain, 10: very severe pain
Time frame: Change from the baseline to 6 months
Patient-reported and healthcare provider-assessed shoulder satisfaction score, 0-100, higher scores mean a better outcome.
Chuncheon Sacred Heart Hospital
Other
The Efficacy of Single-shot Capsule-preserving Hydrodilatation With Corticosteroids in Treating Adhesive Capsulitis of the Shoulder: A Randomized Controlled Trial Versus Isolated Corticosteroid Injection
Acronym: CSvsCSHD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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