Steroid Injection for Adhesive Capsulitis

NCT ID: NCT04364425

Last Updated: 2020-05-14

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-04

Study Completion Date

2021-09-30

Brief Summary

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This study was conducted to compare the efficacy of hydrodilatation with low dose steroid with high dose steroid for treating adhesive capsulitis.

Detailed Description

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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 (hydrodilatation with low dose steroid ) and group 2 (hydrodilatation with high dose steroid). 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, Constant shoulder score, 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 dose steroid

patient received ultrasound-guided 40mg triamcinolone + 4cc xylocaine + 12cc NS

Group Type EXPERIMENTAL

Triamcinolone Acetonide

Intervention Type DRUG

ultrasound guided steroid injection using 1ml of 10mg or 4ml of 40mg triamcinolone acetonide

lidocaine hydrochloride

Intervention Type DRUG

Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)

Normal saline

Intervention Type DRUG

Ultrasound guided injection using 15ml or 12 ml of normal saline

high dose steroid

patient received ultrasound-guided 10mg triamcinolone + 4cc xylocaine + 15cc NS

Group Type ACTIVE_COMPARATOR

Triamcinolone Acetonide

Intervention Type DRUG

ultrasound guided steroid injection using 1ml of 10mg or 4ml of 40mg triamcinolone acetonide

lidocaine hydrochloride

Intervention Type DRUG

Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)

Normal saline

Intervention Type DRUG

Ultrasound guided injection using 15ml or 12 ml of normal saline

Interventions

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Triamcinolone Acetonide

ultrasound guided steroid injection using 1ml of 10mg or 4ml of 40mg triamcinolone acetonide

Intervention Type DRUG

lidocaine hydrochloride

Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)

Intervention Type DRUG

Normal saline

Ultrasound guided injection using 15ml or 12 ml of normal saline

Intervention Type DRUG

Other Intervention Names

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triamcinolone acetonide 10mg/ml (Shincort, YSP, Taiwan) lidocaine hydrochloride (Xylocaine)

Eligibility Criteria

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Inclusion Criteria

1. clinical diagnosis of adhesive capsulitis
2. a duration of complaints more than 3 months
3. a reduction in passive range of motion in at least 2 of the following: forward flexion, abduction, or external rotation of the affected shoulder of more than 30 degree compared with the other side.

Exclusion Criteria

1. prior manipulation of the affected shoulder under anesthesia;
2. other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions, osteoarthritis, damage to the glenohumeral cartilage,osteoporosis, or malignancies in the shoulder region);
3. neurologic deficits affecting shoulder function in normal daily activities;
4. shoulder pain caused by cervical radiculopathy
5. a history of drug allergy to hyaluronic acid;
6. pregnancy or lactation;
7. received injection into the affected shoulder during the preceding 3 months
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taipei veteran general hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Jia chi Wang

Role: CONTACT

0919527693

Facility Contacts

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Jia chi Wang

Role: primary

References

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Wang JC, Hsu PC, Wang KA, Wu WT, Chang KV. Comparative Effectiveness of Corticosteroid Dosages for Ultrasound-Guided Glenohumeral Joint Hydrodilatation in Adhesive Capsulitis: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2023 May;104(5):745-752. doi: 10.1016/j.apmr.2022.11.007. Epub 2022 Dec 12.

Reference Type DERIVED
PMID: 36521580 (View on PubMed)

Other Identifiers

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2019-07-005C

Identifier Type: -

Identifier Source: org_study_id

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