Subacromial Impingement - The Need of Arthroscopic Subacromial Decompression After Eccentric Physical Therapy Exercises
| Tracking Information | |||||
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| First Received Date ICMJE | December 22, 2009 | ||||
| Last Updated Date | June 16, 2011 | ||||
| Start Date ICMJE | January 2008 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
Constant-Murley shoulder assessment [ Time Frame: Baseline and then after three months of exercises ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01037673 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Health Related Quality of Life [ Time Frame: Baseline and after three months of exercises and long term after 12 months ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Subacromial Impingement - The Need of Arthroscopic Subacromial Decompression After Eccentric Physical Therapy Exercises | ||||
| Official Title ICMJE | Does the Need of Arthroscopic Subacromial Decompression Change After Eccentric Physical Therapy Exercises in Patients With Subacromial Pain? - A Randomized Clinical Trial | ||||
| Brief Summary | Objective: A randomized clinical trial in order to evaluate the efficacy of structured eccentric exercises tutored by a physical therapist (PT) for patients with subacromial impingement. Hypothesis: H1 The exercises has a satisfactory effect and the need of an arthroscopic subacromial decompression can be reconsidered. H0 No difference between the two exercises (experimental and active control) and the patients still need surgery Further the study objective is to evaluate predictors for a positive or negative treatment response after three months of rehabilitation as well as after 12 months. Method: Patients referred to the orthopedic unit for an arthroscopic subacromial decompression, are offered a three month rehabilitation program during the waiting time for surgery which is approximately 4-6 months. All patients must have tried conservative treatments for at least 6 months in primary care with unsatisfactory results. The patients will be randomized to either the structured eccentric exercises tutored by a physical therapist or control exercises with general movements for the neck and shoulders. All patients has an equal number of sessions with the PT to offer similar attention. After three months the following key-question has to be answered: due to your current experience of your shoulder problems do you still need this surgical intervention? A blinded orthopedic surgeon evaluates the following outcomes at baseline and after three and twelve months. Primary outcomes: Constant-Murley shoulder assessment, Disabilities of the Arm Shoulder and Hans and different aspects of pain. Secondary outcomes; EQ-5D, sick-leave and return to work. All patients are evaluated with a diagnostic ultrasound in order to reveal the condition of the rotator cuff. Also long-term results in those who go thorough with the surgery and those who decline will be assessed after 12 months. Importance of the study results: Since there is no consensus about which intervention that should be preferred for patients with subacromial impingement the results of the current study is warranted. If this exercise program is successful it can be implemented into clinical practice. Further, clinical characteristics of patients that really need an arthroscopic subacromial decompression can be identified. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Subacromial Impingement Syndrome | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Holmgren T, Björnsson Hallgren H, Öberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. BMJ. 2012 Feb 20;344:e787. doi: 10.1136/bmj.e787. | ||||
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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 | Completed | ||||
| Enrollment ICMJE | 102 | ||||
| Completion Date | June 2011 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Three of these five must be positive:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 30 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Sweden | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01037673 | ||||
| Other Study ID Numbers ICMJE | 88201401 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Kajsa Johansson, Senior lecturer, Linköping University | ||||
| Study Sponsor ICMJE | Linkoeping University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Linkoeping University | ||||
| Verification Date | December 2009 | ||||
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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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