Workers Compensation Board: Rotator Cuff Tear Management
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|ClinicalTrials.gov Identifier: NCT01498198|
Recruitment Status : Unknown
Verified December 2011 by Dr. Peter MacDonald, University of Manitoba.
Recruitment status was: Not yet recruiting
First Posted : December 23, 2011
Last Update Posted : December 23, 2011
The overall goal of this proposed randomized study is to determine if surgery at the time of diagnosis or rehabilitation +/- surgery (i.e. surgery only when rehabilitation fails) results in shorter times to claim closure. The study will examine how often non-operative management is successful in resolving symptoms and allowing subjects to return to work without surgery. The investigators will also examine if there are subject, tear or work-related characteristics that affect the outcome of rehabilitation or expedited surgery and predict whether patients should be referred to operative or non-operative management at time of assessment. At study completion, the investigators expect to be able to definitively state the best management for subjects with these less serious RC tears.
The specific research questions to be addressed are as follows:
- In WCB subjects with high grade partial thickness (>50%) or small full thickness (≤ 1 cm.) rotator cuff tears, how does non-operative management (i.e. rehabilitation) or expedited surgery affect time to claim closure?
- Are there subject, tear or work-related characteristics that affect which patient management approach will be most effective and efficient?
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tear||Procedure: Rotator Cuff Repair Surgery Other: Non Operative Treatment||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Study of Non-Operative Management Versus Expedited Surgery Among WCB Patients With Small Rotator Cuff Tears: Affect Upon Time to Claim Closure in 2 Prairie Provinces|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||January 2014|
Experimental: Expedited Surgery
Participants will have surgery within 3 months
Procedure: Rotator Cuff Repair Surgery
Participants will have surgery within 3 months. They will be followed up at 6 weeks, 12 weeks, 6 months and 12 months pos operatively.
Experimental: Non Operative Management
Participants will undergo non operative care for as long as they are improving, and will return to the surgeon when no progression is reached.
Other: Non Operative Treatment
Participants will undergo a 6 week assessment, and if they are improving they will continue undergoing non operative care up until 12 months. If at any assessment point (6 weeks, 12 weeks, 6 months, 12 months) they are deemed to not be making any more progression, they will be referred back to the surgeon.
- Time to return to final work status [ Time Frame: Participations followed for duration of the study, up to 1 year, until they fully return to work ]To answer our primary research question, time to return to work (in days) will be calculated. This will be defined as the interval from the date of orthopedic consultation/screening to final return to work status. We will also determine the time to any return to work status.
- Demographics [ Time Frame: 1 year ]A complete list of demographic information will be recorded. These include the patient's contact information, age, gender, height, weight, handedness, smoking status, date of injury, injury mechanism, occupation, employment status, type of work performed, and any recreational sports (type/frequency) competing in. Patients will also be asked about the particulars of any previous physical therapy regimen (where, start/stop dates, how many sessions attended), as well as any other non-operative treatments (cortisone, massage therapy, chiropractic, acupuncture).
- Range of Motion [ Time Frame: 1 year ]Range of motion (ROM) assessments will be conducted by the study physical therapist and will performed for shoulder flexion, abduction, external rotation (neutral abduction, 90° elbow flexion), external rotation (90° abduction, 90° elbow flexion), and internal rotation (90° abduction, 90° elbow flexion). Active and passive ROM will be measured for both the operative and unaffected shoulder. ROM values will be expressed as raw values, as well as percentage of ROM compared to the unaffected shoulder.
- WORC Questionnaire [ Time Frame: 1 year ]The Western Ontario Rotator Cuff Index (WORC) is a five-part (physical symptoms, sports/recreation, work, lifestyle, emotions), 21-item, disease-specific questionnaire which assesses quality of life among patients with RC pathology. This index has been shown to be valid, reliable and responsive in the rotator cuff patient population.
- Orebro Questionnaire [ Time Frame: 1 year ]The Orebro Musculoskeletal Pain Questionnaire (OMPQ) is a validated instrument that examines subject's ability to manage their pain during daily life. It is predictive of the subject's ability to return to work following injury and will be used at the initial assessment.
- Strength [ Time Frame: 1 year ]Strength assessments will also be conducted by the study physical therapist at the baseline, 6-month, and 12-month intervals. Isometric shoulder flexion, abduction, external rotation and internal rotation will be measured with the patient's arm in neutral (neutral abduction, 90° elbow flexion). Strength will be measured using a dynamometer. Peak values will be recorded during each contraction, to be held for 3 seconds each. Strength values will be expressed as raw values, as well as percentage of strength compared to the unaffected shoulder.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01498198
|Contact: Jeff Leiter, PhDemail@example.com|
|Contact: Alexandra J Gilhen, BScfirstname.lastname@example.org|
|Pan Am Clinic||Not yet recruiting|
|Winnipeg, Manitoba, Canada, R3M 3E4|
|Contact: Jeff Leiter, PhD 204-927-2665 email@example.com|
|Contact: Alexandra J Gilhen, BSc 204-925-1558 firstname.lastname@example.org|
|Principal Investigator:||Peter B MacDonald, MD FRCSC||University of Manitoba Faculty of Medicine|