Rotator Interval and Intra-articular Corticosteroid Injection for Frozen Shoulder

November 24, 2013 updated by: Tore Prestegaard, Oslo University Hospital

Rotator Interval and Intra-articular Corticosteroid Injection for Adhesive Capsulitis (Frozen Shoulder): a Randomised, Double Blind, Placebo Controlled Trial

The purpose of this study is to compare ultrasound guided capsular corticosteroid injection into the rotator interval/anterior capsule and the GH joint with ultrasound guided corticosteroid injection into the GH joint only. Both methods will be compared with placebo injections.

Primary outcome measure: pain reduction at week 6 Secondary outcome measures: improvement of function (SPADI, Life quality, ROM).

0-hypothesis: no difference between the methods.

The investigators want to find out if the clinical effect of the combined capsular and intra-articular injections are better than placebo and better that intra-articular injections

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

3 groups, 50 patients in each, follow-up visits after 3, 6, 12 and 26 weeks.

Study Type

Interventional

Enrollment (Actual)

122

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

  • Norway
      • Stavern, Norway, 3294
        • Vestfold Hospitalt Trust, Clinic Physical Medicine and Rehabilitation

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

21 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pain and stiffness in one shoulder 1 - 6 months
  • Restriction of passive ROM; >= 30 degrees in two or more planes compared to other shoulder

Exclusion Criteria:

  • Systemic inflammatory disease
  • Corticosteroid treatment last 3 months
  • Poorly controlled Diabetes mellitus
  • Pregnancy
  • Contraindications/allergy to corticosteroids and/or Lidocaine
  • Severe infections
  • Osteoarthritis of the shoulder
  • Fractures of the shoulder
  • Rotator cuff pathology causing pain or disability
  • Fibromyalgia
  • Not able to understand Norwegian

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 capsular & intra-articular
corticosteroid injection (Triamcinolone) in capsule/rotator interval and intra-articular
Drug: Triamcinolone hexacetonide
20 mg
Drug: Triamcinolone hexacetonide
1 ml (20 mg) + 6 ml Lidocaine 10 mg/ml
Active Comparator: 2 intra-articular
corticosteroid injection (Triamcinolone) intra-articular placebo injection (Lidocaine) in capsule
Drug: Triamcinolone hexacetonide
20 mg
Drug: Triamcinolone hexacetonide
1 ml (20 mg) + 6 ml Lidocaine 10 mg/ml
Placebo Comparator: 3 placebo
placebo injections (Lidocaine) in capsule and intra-articular
Drug: Triamcinolone hexacetonide
20 mg
Drug: Triamcinolone hexacetonide
1 ml (20 mg) + 6 ml Lidocaine 10 mg/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain reduction
Time Frame: 2-3 years
2-3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Function (ROM, SPADI), Life quality
Time Frame: 2-3 years
2-3 years

Collaborators and Investigators

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

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Tore A Prestgaard, MD, The Hospital of Vestfold

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

February 8, 2009

First Submitted That Met QC Criteria

February 9, 2009

First Posted (Estimate)

February 10, 2009

Study Record Updates

Last Update Posted (Estimate)

November 26, 2013

Last Update Submitted That Met QC Criteria

November 24, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-08546
  • REK (Other Identifier: Regional Etisk Komite)
  • Interne tjenester (Other Identifier)
  • IT-avdelingen (Other Identifier: 2008/5000)
  • Rikshospitalet HF (Other Identifier)

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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