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Sponsored by: |
Helsinki University |
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Information provided by: | Helsinki University |
ClinicalTrials.gov Identifier: | NCT00428870 |
Shoulder impingement syndrome is common and number of operations done per year is growing. The aim of this study is to compare the value of arthroscopic subacromial decompression (acromioplasty group) vs. diagnostic arthroscopy (control group) vs. supervised exercise therapy (conservative group) on subjects with chronic subacromial impingement syndrome. The results of treatment are measured at 3 months, 6 months, 12 months and 24 months. Main outcome measures are Pain at rest and activity (VASs), functional assessment of the shoulder with Constant score and Simple Shoulder test (SST), global assessment of change , quality of life assessment (SF-36 and 15D) and costs.
Condition | Intervention | Phase |
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Subacromial Impingement Syndrome |
Procedure: Arthroscopy or arthroscopic acromioplasty |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Arthroscopic Decompression Versus Diagnostic Arthroscopy Without Subacromial Decompression Versus Supervised Exercise Therapy in Treatment of Subacromial Impingement Syndrome. A Blinded Randomized Controlled Trail. |
Estimated Enrollment: | 210 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | December 2009 |
Ages Eligible for Study: | 35 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
In the first phase orthopaedists select consecutive female or male patients who are admitted to the hospital policlinic of Helsinki University Hospital, (either Töölö Hospital or Jorvi Hospital) or District Hospital of Tampere (Hatanpää Hospital) and fulfil the following inclusion criteria:
Exclusion Criteria:
Contact: Mika Paavola, MD, PhD | +358-50-4272481 | mika.paavola@hus.fi |
Finland, HUS | |
Helsinki University Hospital, Töölö Hospital | Recruiting |
Helsinki, HUS, Finland, FIN-00029 | |
Contact: Jarkko Pajarinen, MD, PhD +358-50-4271930 jarkko.pajarinen@hus.fi |
Principal Investigator: | Mika Paavola, MD, PhD | 1.1.2003 |
Study Chair: | Teppo Jarvinen, MD, PhD | 1.1.2004 |
Study Chair: | Antti Malmivaara, MD, PhD | 1.8.2004 |
Study Chair: | Pekka Paavolainen, Professor | 1.1.2003 |
Study Chair: | Timo Järvelä, MD, PhD | 1.1.2004 |
Study Chair: | Simo Taimela, MD, PhD | 1.6.2004 |
Study Chair: | Harri Sintonen, Professor | 1.8.2004 |
Study Director: | Markku Järvinen, Professor | 1.1.2004 |
Study ID Numbers: | R04200 |
Study First Received: | January 29, 2007 |
Last Updated: | January 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00428870 |
Health Authority: | Finland: Helsinki University Hospital; Finland: Tampere University Hospital |
Shoulder impingement concervative acromioplasty arthroscopy |
Musculoskeletal Diseases Joint Diseases Shoulder Impingement Syndrome |
Pathologic Processes Disease Syndrome |