Comparison of Different Volume of Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis

Taipei Veterans General Hospital

Status: Enrolling

Conditions: Adhesive Capsulitis

Treatments: Drug: Normal saline 2cc; Drug: Xylocaine 2 % Injectable Solution; Drug: steroid; Drug: normal saline 12cc

Study type: Interventional

Funder types: Other

Identifiers

NCT05818111

2022-12-001B

Details and patient eligibility

About

This study was conducted to compare the efficacy of low volume steroid hydrodilatation with high volume steroid hydrodilatation under ultrasonographic guidance for treating adhesive capsulitis

Full description

adhesive capsulitis is a common cause of shoulder pain, and the efficacy of most interventions is limited. This study was conducted to compare the efficacy of low volume steroid hydrodilatation with high volume steroid hydrodilatation under ultrasonographic guidance for treating adhesive capsulitis Design: a prospective, double-blinded, randomized, clinical trial

Patient and methods:

Patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 (10cc steroid hydrodilatation under ultrasonographic guidance ) and group 2 (20cc steroid hydrodilatation). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, Shoulder Pain And Disability Index

Enrollment: 86 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age 35-65 years (to prevent the inclusion of patients with secondary AC), 2) onset of shoulder stiffness since over a month, and 3) limitation in the passive range of motion (ROM) over 30° when compared with the contralateral side in at least two of these three movements: forward flexion, abduction, or external rotation.

Exclusion criteria

1. ultrasound findings of rotator cuff tears, 2) plain radiography findings of significant glenohumeral joint arthritis, 3) accompanying cervical radiculopathy, 4) systemic inflammatory joint disease, 5) intraarticular injection into the glenohumeral joint within the past 3 months, 6) history of surgery on the affected shoulders, 7) regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids, and 8) allergy to corticosteroid or lidocaine.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups

low volume hydrodilatation

Experimental group

Description:

patient received ultrasound-guided low volume steroid hydrodilatation (4cc shincort + 4cc 2% xylocaine +2cc normal saline)

Treatment:

Drug: Normal saline 2cc

Drug: steroid

Drug: Xylocaine 2 % Injectable Solution

high volume hydrodilatation

Active Comparator group

Description:

patient received ultrasound-guided high volume steroid hydrodilatation (4cc shincort + 4cc 2% xylocaine +12cc normal saline)

Treatment:

Drug: normal saline 12cc

Drug: steroid

Drug: Xylocaine 2 % Injectable Solution