Workers Compensation Board: Rotator Cuff Tear Management

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University of Manitoba.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
University of Alberta
Information provided by (Responsible Party):
Dr. Peter MacDonald, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01498198
First received: December 19, 2011
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

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:

  1. 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?
  2. Are there subject, tear or work-related characteristics that affect which patient management approach will be most effective and efficient?

Condition Intervention
Rotator Cuff Tear
Procedure: Rotator Cuff Repair Surgery
Other: Non Operative Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Demographics [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The Western Ontario Rotator Cuff Index (WORC)[9] 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 144
Study Start Date: January 2012
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is over 18 years of age
  • Patient has an active WCB Claim
  • Patient has a high-grade (>50%) partial-thickness or small (<1cm) full-thickness tear of the supraspinatus and/or infraspinatus, as confirmed by appropriate diagnostic imaging (MRI, Arthrogram, Ultrasound)

Exclusion Criteria:

  • Patient has a full-thickness tear of the subscapularis and/or teres minor
  • Patient has a low-grade (<50%) partial-thickness tear of the supraspinatus/infraspinatus
  • Patient has a moderate to large (>1cm) full-thickness tear of the supraspinatus/infraspinatus
  • Patient has undergone previous RC surgery to the affected shoulder
  • Patient has major joint trauma, infection, or avascular necrosis
  • Patient has chronic dislocation, inflammation, or degenerative glenohumeral arthropathy
  • Patient has evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging)
  • Patient has a psychiatric illness, cognitive impairment, or other health condition (i.e. visual impairment) which precludes informed consent or renders the patient unable to complete study questionnaires
  • Patient has a major medical illness where life expectancy is less than 2 years
  • Patient does not speak/read/understand English
  • Patient has no fixed address or means of contact
  • Patient unwilling to complete necessary follow-ups
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498198

Contacts
Contact: Jeff Leiter, PhD 204-927-2665 jleiter@panamclinic.com
Contact: Alexandra J Gilhen, BSc 204-925-1558 agilhen@panamclinic.com

Locations
Canada, Manitoba
Pan Am Clinic Not yet recruiting
Winnipeg, Manitoba, Canada, R3M 3E4
Contact: Jeff Leiter, PhD    204-927-2665    jleiter@panamclinic.com   
Contact: Alexandra J Gilhen, BSc    204-925-1558    agilhen@panamclinic.com   
Sponsors and Collaborators
University of Manitoba
University of Alberta
Investigators
Principal Investigator: Peter B MacDonald, MD FRCSC University of Manitoba Faculty of Medicine
  More Information

No publications provided

Responsible Party: Dr. Peter MacDonald, Pan Am Clinic Medical Director and University of Manitoba Faculty of Medicine Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT01498198     History of Changes
Other Study ID Numbers: B2011:117
Study First Received: December 19, 2011
Last Updated: December 22, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
Rotator Cuff
WCB

ClinicalTrials.gov processed this record on August 20, 2014