Treatment Study of Frozen Shoulder: Corticosteroid Injection in Joint Versus Wait and See Policy (FSS)

May 26, 2015 updated by: Satya Pal Sharma

Outcome in Shoulder Capsulitis (Frozen Shoulder) Between Corticosteroid and Corticosteroid With Distension Compared to Wait and See Policy, a Randomised Controlled Trial

This is a study on the treatment of frozen shoulder with injection of cortisone into the shoulder joint. The purpose of the study is to evaluate whether injection with stretching of the shoulder capsule or plain injection is more effective than no specific treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Shoulder capsulitis or frozen shoulder is a painful condition causing limitations of shoulder movements. Its incidence is about 2%, comprising mostly women. There is a need for more controlled trials on frozen shoulder preferably in general practice, without using technical guiding instruments for injections as MRI or computer tomography, because the condition is routinely treated in general practice. It was therefore important to conduct this study as similar as possible to current practice. The procedure should be simple, safe and less time consuming.

Patients will be allocated to the study groups by computerized block-randomization with three permutations per block. Group 1 consists of patients receiving Triamcinolone 20 mg intraarticular injection with Lidocaine 10mg/ml 3 ml and a total of 4 ml solution. Group 2 patients will receive intraarticular Triamcinolone 20 mg, 3 ml Lidocaine and the rest with physiological natrium chloride 9 mg/ml, comprising a total volume from 8 ml and upwards up to 20 ml. Group 3 will serve as a control group and patients in this group could receive any other treatment other than corticosteroid injections or per oral corticosteroid medication. The control group will remain without treatment with corticosteroids, in injection or tablet form till 61 days, which is also the last day of the outcome measurements. The time interval between the 1st and 2nd treatment will be 7 days, between the 2nd and 3rd treatment 10 days, and between the 3rd and 4th treatment 14 days. Patients will also receive a follow-up by mail 6 and 12 months after the inclusion, where pain and function (SPADI) is investigated.

The patients will be explained and instructed in filling out schema for SPADI, NPRS, pain figure, for sleep Bergen Insomnia Scale (BIS), EPQ-N to measure neuroticism, and Subjective Health Complaints (SHC).

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

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
    • Hordaland
      • Ulset, Hordaland, Norway, NO-5115
        • Rolland legesenter

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who on clinical examination show reduced shoulder movements with pain where commonly lateral rotation is most restricted, medial rotation least restricted and abduction is somewhat restricted, somewhere in between the two other movements, is called a capsular pattern of movement confirming shoulder capsulitis
  • Had had the condition for at least 2 months
  • Reduction of movement is at least 30% of normal in two of the three passive movements
  • Are ready to undergo treatment as set up before hand (agree to participate in one of the three groups)
  • Agree not to undergo other treatment simultaneously directed at the stiff shoulder other than in the control group
  • Patient has voluntarily given his/her written consent for participation
  • Has not already received intraarticular corticosteroid injection prior to entry in the study less than 4 weeks earlier

Exclusion Criteria:

  • Diabetes, as in some diabetic patients, steroids can disturb the regulation of their blood sugar levels.
  • One of the two shoulder movements are normal, either passive abduction or passive lateral rotation
  • Have some systemic disease where use of corticosteroids is either contraindicated or affect the coexisting disorder
  • Patients with asthma using steroid inhalations or steroids orally
  • There are other coexisting disorders in the arm or patient has a painful neck that can disturb pain and functional assessment of the shoulder
  • Pregnant and breast feeding mothers
  • Patients under 18 years of age
  • Patients who do not understand Norwegian
  • Patients who have reduced intellectual capacity for consent-giving

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Steroid injection Without distension
Group 1 consists of patients receiving Triamcinolone acetonide 20 mg intraarticular injection with Lidocaine 10mg/ml 3 ml and a total of 4 ml solution.
Drug: Triamcinolone Acetonide
Triamcinolone 20 mg intraarticular injection with Lidocaine 10mg/ml 3 ml and variable amount of saline of 4 ml solution on day 1, day 7, day 17 and day 31st.
Other Names:
  • Kenacort-T H02A B08
Drug: Triamcinolone Acetonide
Patients in group 2 will receive intraarticular Triamcinolone 20 mg, 3 ml Lidocaine and physiological natrium chloride 9 mg/ml, comprising a total volume from 8 ml and upwards up to 20 ml
Other Names:
  • Kenacort-T H02A B08
Active Comparator: Steroid with distension
Patients in group 2 will receive intraarticular Triamcinolone Acetonide 20 mg, 3 ml Lidocaine and physiological natrium chloride 9 mg/ml, comprising a total volume from 8 ml and upwards up to 20 ml
Drug: Triamcinolone Acetonide
Triamcinolone 20 mg intraarticular injection with Lidocaine 10mg/ml 3 ml and variable amount of saline of 4 ml solution on day 1, day 7, day 17 and day 31st.
Other Names:
  • Kenacort-T H02A B08
Drug: Triamcinolone Acetonide
Patients in group 2 will receive intraarticular Triamcinolone 20 mg, 3 ml Lidocaine and physiological natrium chloride 9 mg/ml, comprising a total volume from 8 ml and upwards up to 20 ml
Other Names:
  • Kenacort-T H02A B08
No Intervention: Control
Group 3 will serve as control group and patients in this group could receive any other treatment other than corticosteroid injections or per oral corticosteroid medication. The control group will remain without treatment with corticosteroids, in injection or tablet form till 61 days, which is also the last day of the outcome measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder pain and disability index (SPADI)
Time Frame: 8 weeks
The primary outcome measure is Shoulder Pain and Disability Index (SPADI). According to a previous study, the SPADI score of ≥10 indicate clinically important improvement (or worsening) of shoulder function (Williams et al. 1995). A total of 3 measurements will be taken for all participants: baseline measurement on day 1, 2nd measurement on the 31st day and last measurement the 61st day. All end point effect measurements (primary, secondary & tertiary) are targeted at 61 days.In addition pain and function (SPADI) will be evaluated at 6 months and 12 months.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A 10-point Numerical Pain Rating Scale (NPRS)
Time Frame: 8 weeks
A total of 3 measurements will be taken for all participants: baseline measurement on day 1, 2nd measurement on the 31st day and last measurement the 61st day. All end point effect measurements (primary, secondary & tertiary) are targeted at 61 days.
8 weeks

Collaborators and Investigators

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

Sponsor

Satya Pal Sharma

Collaborators

Norwegian Medical Association

Investigators

  • Study Chair: Anders Barheim, MD PhD, University of Bergen

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, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

March 27, 2012

First Submitted That Met QC Criteria

April 2, 2012

First Posted (Estimate)

April 4, 2012

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSS-2010-SKB
  • 2008-004385-49 (EudraCT Number)

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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