Capsular and Intra-articular Corticosteroid Injection for Frozen Shoulder
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Oslo University Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Oslo University Hospital
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00840229
First received: February 8, 2009
Last updated: June 24, 2011
Last verified: June 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 8, 2009 | ||||||||
| Last Updated Date | June 24, 2011 | ||||||||
| Start Date ICMJE | February 2009 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Pain reduction [ Time Frame: 2-3 years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00840229 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Function (ROM, SPADI, Constant score) Life quality [ Time Frame: 2-3 years ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Capsular and Intra-articular Corticosteroid Injection for Frozen Shoulder | ||||||||
| Official Title ICMJE | Capsular and Intra-articular Corticosteroid Injection for Adhesive Capsulitis (Frozen Shoulder): a Randomised, Double Blind, Placebo Controlled Trial | ||||||||
| 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 Secondary outcome measures: improvement of function (SPADI, Constant score, 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 |
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| Detailed Description | 3 groups, 50 patients in each, follow-up visits after 3, 6, 12 and 26 weeks. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Adhesive Capsulitis | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 150 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 25 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Norway | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00840229 | ||||||||
| Other Study ID Numbers ICMJE | S-08546, REK, Interne tjenester, IT-avdelingen, Rikshospitalet HF | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Tore A. Prestgaard, MD, Vestfold Hospital Trust, Clinic Physical Medicine and Rehabilitaion | ||||||||
| Study Sponsor ICMJE | Oslo University Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Oslo University Hospital | ||||||||
| Verification Date | June 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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