Rotator Interval and Intra-articular Corticosteroid Injection for Frozen Shoulder
5 other identifiers
interventional
122
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 8, 2009
CompletedFirst Posted
Study publicly available on registry
February 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedNovember 26, 2013
November 1, 2013
3.3 years
February 8, 2009
November 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain reduction
2-3 years
Secondary Outcomes (1)
Function (ROM, SPADI), Life quality
2-3 years
Study Arms (3)
1 capsular & intra-articular
EXPERIMENTALcorticosteroid injection (Triamcinolone) in capsule/rotator interval and intra-articular
2 intra-articular
ACTIVE COMPARATORcorticosteroid injection (Triamcinolone) intra-articular placebo injection (Lidocaine) in capsule
3 placebo
PLACEBO COMPARATORplacebo injections (Lidocaine) in capsule and intra-articular
Interventions
Eligibility Criteria
You may qualify if:
- Pain and stiffness in one shoulder 1 - 6 months
- Restriction of passive ROM; \>= 30 degrees in two or more planes compared to other shoulder
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vestfold Hospitalt Trust, Clinic Physical Medicine and Rehabilitation
Stavern, 3294, Norway
Related Publications (1)
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.
PMID: 25919473DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tore A Prestgaard, MD
The Hospital of Vestfold
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, consultant physician
Study Record Dates
First Submitted
February 8, 2009
First Posted
February 10, 2009
Study Start
February 1, 2009
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
November 26, 2013
Record last verified: 2013-11