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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2024-02-01

Brief Summary

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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

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Detailed Description

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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

Conditions

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Adhesive Capsulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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low volume hydrodilatation

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

Group Type EXPERIMENTAL

steroid

Intervention Type DRUG

triamcinolone 40mg 4cc

Xylocaine 2 % Injectable Solution

Intervention Type DRUG

xylocaine 2% 4cc

Normal saline 2cc

Intervention Type DRUG

normal saline 2cc

high volume hydrodilatation

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

Group Type ACTIVE_COMPARATOR

steroid

Intervention Type DRUG

triamcinolone 40mg 4cc

Xylocaine 2 % Injectable Solution

Intervention Type DRUG

xylocaine 2% 4cc

normal saline 12cc

Intervention Type DRUG

normal saline 12cc

Interventions

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steroid

triamcinolone 40mg 4cc

Intervention Type DRUG

Xylocaine 2 % Injectable Solution

xylocaine 2% 4cc

Intervention Type DRUG

Normal saline 2cc

normal saline 2cc

Intervention Type DRUG

normal saline 12cc

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No