Rotator Interval and Intra-articular Corticosteroid Injection for Frozen Shoulder
Primary Purpose
Adhesive Capsulitis
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Triamcinolone hexacetonide
Triamcinolone hexacetonide
Sponsored by
About this trial
This is an interventional treatment trial for Adhesive Capsulitis focused on measuring adhesive capsulitis, corticosteroids, injection, pain
Eligibility Criteria
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
Sites / Locations
- Vestfold Hospitalt Trust, Clinic Physical Medicine and Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
1 capsular & intra-articular
2 intra-articular
3 placebo
Arm Description
corticosteroid injection (Triamcinolone) in capsule/rotator interval and intra-articular
corticosteroid injection (Triamcinolone) intra-articular placebo injection (Lidocaine) in capsule
placebo injections (Lidocaine) in capsule and intra-articular
Outcomes
Primary Outcome Measures
Pain reduction
Secondary Outcome Measures
Function (ROM, SPADI), Life quality
Full Information
NCT ID
NCT00840229
First Posted
February 8, 2009
Last Updated
November 24, 2013
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00840229
Brief Title
Rotator Interval and Intra-articular Corticosteroid Injection for Frozen Shoulder
Official Title
Rotator Interval and Intra-articular Corticosteroid Injection for Adhesive Capsulitis (Frozen Shoulder): a Randomised, Double Blind, Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
3 groups, 50 patients in each, follow-up visits after 3, 6, 12 and 26 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
adhesive capsulitis, corticosteroids, injection, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 capsular & intra-articular
Arm Type
Experimental
Arm Description
corticosteroid injection (Triamcinolone) in capsule/rotator interval and intra-articular
Arm Title
2 intra-articular
Arm Type
Active Comparator
Arm Description
corticosteroid injection (Triamcinolone) intra-articular placebo injection (Lidocaine) in capsule
Arm Title
3 placebo
Arm Type
Placebo Comparator
Arm Description
placebo injections (Lidocaine) in capsule and intra-articular
Intervention Type
Drug
Intervention Name(s)
Triamcinolone hexacetonide
Intervention Description
20 mg
Intervention Type
Drug
Intervention Name(s)
Triamcinolone hexacetonide
Intervention Description
1 ml (20 mg) + 6 ml Lidocaine 10 mg/ml
Primary Outcome Measure Information:
Title
Pain reduction
Time Frame
2-3 years
Secondary Outcome Measure Information:
Title
Function (ROM, SPADI), Life quality
Time Frame
2-3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tore A Prestgaard, MD
Organizational Affiliation
The Hospital of Vestfold
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vestfold Hospitalt Trust, Clinic Physical Medicine and Rehabilitation
City
Stavern
ZIP/Postal Code
3294
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
25919473
Citation
Prestgaard T, Wormgoor MEA, Haugen S, Harstad H, Mowinckel P, Brox JI. Ultrasound-guided intra-articular and rotator interval corticosteroid injections in adhesive capsulitis of the shoulder: a double-blind, sham-controlled randomized study. Pain. 2015 Sep;156(9):1683-1691. doi: 10.1097/j.pain.0000000000000209.
Results Reference
derived
Learn more about this trial
Rotator Interval and Intra-articular Corticosteroid Injection for Frozen Shoulder
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