Steroid Injection for Adhesive Capsulitis

May 13, 2020 updated by: Taipei Veterans General Hospital, Taiwan

Comparing Low Dose and High Dose Steroid Injection for Adhesive Capsulitis

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: low dose steroid
patient received ultrasound-guided 40mg triamcinolone + 4cc xylocaine + 12cc NS
Drug: Triamcinolone Acetonide
ultrasound guided steroid injection using 1ml of 10mg or 4ml of 40mg triamcinolone acetonide
Other Names:
  • triamcinolone acetonide 10mg/ml (Shincort, YSP, Taiwan)
Drug: lidocaine hydrochloride
Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)
Other Names:
  • lidocaine hydrochloride (Xylocaine)
Drug: Normal saline
Ultrasound guided injection using 15ml or 12 ml of normal saline
ACTIVE_COMPARATOR: high dose steroid
patient received ultrasound-guided 10mg triamcinolone + 4cc xylocaine + 15cc NS
Drug: Triamcinolone Acetonide
ultrasound guided steroid injection using 1ml of 10mg or 4ml of 40mg triamcinolone acetonide
Other Names:
  • triamcinolone acetonide 10mg/ml (Shincort, YSP, Taiwan)
Drug: lidocaine hydrochloride
Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)
Other Names:
  • lidocaine hydrochloride (Xylocaine)
Drug: Normal saline
Ultrasound guided injection using 15ml or 12 ml of normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in pain intensity
Time Frame: 0, 6, 12 wks.
pain intensity was measured by visual analog scale (0-10)
0, 6, 12 wks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Shoulder Pain And disability index
Time Frame: 0, 6, 12 wks.
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.
0, 6, 12 wks.
change in glenohumeral joint range of motion
Time Frame: 0, 6, 12 wks.
Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position.
0, 6, 12 wks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 4, 2020

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

September 1, 2021

Study Registration Dates

First Submitted

April 20, 2020

First Submitted That Met QC Criteria

April 26, 2020

First Posted (ACTUAL)

April 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 14, 2020

Last Update Submitted That Met QC Criteria

May 13, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-07-005C

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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