Early Mobilization Following Arthroscopic Rotator Cuff Repair

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Shoulder & Upper Extremity Research Group of Edmonton
Sponsor:
Information provided by (Responsible Party):
Shoulder & Upper Extremity Research Group of Edmonton
ClinicalTrials.gov Identifier:
NCT01333527
First received: April 8, 2011
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

Shoulder rotator cuff (RC) tears are a significant cause of pain and disability. Surgery is done to reconnect the torn RC tendon(s) to the bone. The goals of RC surgery are to decrease pain, and to increase range of motion (ROM) and strength. This is done arthroscopically; through a small incision in the patient's shoulder. After surgery, patients are usually placed in a sling for up to 6 weeks to protect the repaired shoulder tendons. During this time, ROM exercises are only done by using the un-operated arm for assistance. Voluntary or active shoulder movement is usually not permitted to allow the repaired tendons to heal. Unfortunately, some patients develop shoulder stiffness while wearing the sling, which can delay rehabilitation. Any delays in rehabilitation may result in reduced shoulder function, a slower return-to-work or daily activities, and may also impact the health care system, through increased use and cost of rehabilitation.

This study's purpose is to determine if patients can safely stop wearing their sling as early as pain and comfort allow following RC surgery. A total of 200 patients (100 per group) will be randomly assigned to one of two study groups:

Patients in Group A (accelerated rehab) will wear their sling for comfort only following surgery. Self-assisted ROM exercises are allowed at any time. This means that patients may stop wearing their sling if pain and comfort allow, and start active movement for activities of daily living only.

Patients in Group B (standard rehab) will wear their sling for 6 weeks. Like in group A, self-assisted ROM exercises are allowed at any time, but active movement will not be allowed until 6 weeks after surgery. Patients in both groups will be given the same self-assisted ROM exercises after surgery.

Patients who agree to participate in the study will see their surgeon and the study physical therapist/research coordinator on 6 occasions (pre-surgery, 2 weeks, 6 weeks, 3, 6, 12 months post-surgery). Each visit will take about 30 minutes and will include a ROM assessment, strength assessment (as appropriate) and disease-specific quality of life questionnaires. Patients will also undergo an Ultrasound exam to verify that their RC repair is intact at 12-months. Differences in ROM, strength, questionnaire scores, RC integrity, and adverse events will be examined between the two groups. Differences will also be examined according to RC tear size and patient characteristics.


Condition Intervention Phase
Rotator Cuff Tear
Procedure: No Sling
Procedure: Sling
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Mobilization Following Arthroscopic Rotator Cuff Repair: a Randomized Controlled Trial

Further study details as provided by Shoulder & Upper Extremity Research Group of Edmonton:

Primary Outcome Measures:
  • WORC Questionnaire [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Strength [ Time Frame: Baseline, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • ASES [ Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months ] [ Designated as safety issue: No ]
    Quality of life's questionnaires

  • Adverse Events [ Time Frame: 2 weeks, 6 weeks, 3 months, 6months ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months ] [ Designated as safety issue: No ]
    quality of life's questionnaire

  • Range of Motion (ROM) [ Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A (early ROM)
Group A (early ROM) will use the sling for comfort only
Procedure: No Sling
Early range of motion
Active Comparator: Group B (usual care)
Group B (usual care) will be immobilized in a sling for 6 weeks.
Procedure: Sling
Patients will use the sling for 6 weeks, as per usual care

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is over 18 years of age
  2. Patient has attempted non-operative treatment (i.e. physical therapy consisting of progressive ROM, strengthening, and postural exercises)
  3. Patient has a full-thickness tear of the supraspinatus and/or infraspinatus, as confirmed by appropriate diagnostic imaging (MRI, Arthrogram, Ultrasound)

Exclusion Criteria:

  1. Patient has a full-thickness tear of the subscapularis and/or teres minor
  2. Patient has undergone previous RC surgery to the affected shoulder
  3. Patient has major joint trauma, infection, or avascular necrosis
  4. Patient has chronic dislocation, inflammation, or degenerative glenohumeral arthropathy
  5. Patient has evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging)
  6. 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
  7. Patient has a major medical illness where life expectancy is less than 2 years
  8. Patient does not speak/read/understand English
  9. Patient has no fixed address or means of contact
  10. Surgeon or patient has decided to cancel surgery
  11. Surgeon concludes that an arthroscopic repair is not appropriate at time of surgery (based on RC tear characteristics or concomitant shoulder pathology)
  12. 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: NCT01333527

Contacts
Contact: Anelise Silveira 780-407-6992 anelise.silveira@albertahealthservices.ca
Contact: Fiona Styles-Tripp 780-735-7067 Fiona.StylesTripp@albertahealthservices.ca

Locations
Canada, Alberta
Glen Sather Sports Medicine clinic Recruiting
Edmonton, Alberta, Canada, T6G 2H9
Contact: Megan Sergenson    1-780-492-4752      
Sponsors and Collaborators
Shoulder & Upper Extremity Research Group of Edmonton
Investigators
Principal Investigator: David Sheps, MD,MSc,FRCSC University of Alberta
  More Information

No publications provided

Responsible Party: Shoulder & Upper Extremity Research Group of Edmonton
ClinicalTrials.gov Identifier: NCT01333527     History of Changes
Other Study ID Numbers: RES0005824
Study First Received: April 8, 2011
Last Updated: January 15, 2013
Health Authority: Canada: Health Research Ethics Board

ClinicalTrials.gov processed this record on October 23, 2014