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Early Mobilization Following Mini-Open Rotator Cuff Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741272
Recruitment Status : Completed
First Posted : December 4, 2012
Results First Posted : March 17, 2015
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Shoulder & Upper Extremity Research Group of Edmonton

Brief Summary:

The primary objective of this study is to determine if early active range of motion after mini-open rotator cuff repair in adults results in improved shoulder range of motion at 6 weeks and 3 months after surgery. The secondary objective of this study is to determine if early mobilization improves disease-specific quality of life and promotes earlier return to work/function.

Hypothesis: Adults undergoing mini-open rotator cuff repair will have faster recovery of range of motion, improved disease specific quality of life and earlier return to work/function if allowed to begin early active range of motion compared to subjects who are immobilized in a sling for 6 weeks.


Condition or disease Intervention/treatment Phase
Full Thickness Rotator Cuff Tears Procedure: Sling Procedure: No sling Phase 4

Detailed Description:

The rotator cuff is a group of four muscles around the shoulder. They function to provide both shoulder mobility and power as well as stability. Rotator cuff tears can be a significant cause of pain and disability for the patient. Surgical repair is done to reconnect the torn tendon(s) to the bone and has been shown to be an effective treatment in the presence of full-thickness tears. The goals of Rotator Cuff (RC)surgery are to decrease pain, increase range of motion(ROM) and strength. This is done with a small incision called a mini-open. Standard care following this surgical repair is to be placed in a sling for 6 weeks to protect the repaired shoulder tendons. During this time ROM exercises are done using the non-operated arm for assistance. No active or voluntary movement is allowed during the first 6 weeks. Unfortunately, some of these patients develop shoulder stiffness which slows their recovery and return to work or daily activities and may result in increased use and cost of rehabilitation services.

The purpose of this study is to determine if following a RC repair, patients can safely stop wearing their sling and begin active ROM for activities of daily living as early as pain and comfort allow. A total of 190 patients have been recruited to this study (95/group) were randomly assigned to one of two study groups. Patients in Group A (sling for 6 weeks) will wear their sling for 6 weeks. Self-assisted ROM exercises are allowed at any time, but active movement will not be allowed until 6 weeks after surgery. Patients in Group B (Sling as needed) will be allowed to remove their sling as early as pain and comfort allow. Self-assisted ROM exercises are allowed at any time as are active ROM for activities of daily living. Patients who agree to participate will be seen by their surgeon and the research coordinator for a baseline assessment before surgery and again at 2 & 6 weeks, 3, 6, 12 and 24 months after surgery. Each visit will include a ROM assessment and disease specific quality of life questionnaires. Patients will also undergo an Ultrasound exam at a minimum of 2 years after surgery to verify the integrity of their RC repair. Differences in ROM, questionnaire scores, RC integrity and adverse events will be examined between the two groups.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Mobilization Following Mini-Open Rotator Cuff Repair: A Randomized Clinical Trial
Study Start Date : September 2003
Actual Primary Completion Date : January 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Active Comparator: Group A (Usual Care)
Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling
Procedure: Sling
Patients will use a sling for 6 weeks as per usual care. No active ROM allowed.

Experimental: Group B (Early ROM)
Will use the sling for comfort only. Intervention: Procedure: No sling
Procedure: No sling
Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living.




Primary Outcome Measures :
  1. Change in Range of Motion (ROM)From Baseline to 24 Months [ Time Frame: Baseline, 6 weeks, 3, 6, 12, 24 months ]

    Two-way repeated-measures analysis of variance (ANOVA) compared shoulder ROM between groups over time. Standing: Active flexion, scaption, abduction, extension, internal rotation (vertebral level).

    Supine Lying: Active and passive flexion, abduction, external rotation (arm at side), external rotation (arm at 90 degrees abduction), internal rotation (arm at side), internal rotation (arm at 90 degrees abduction),and horizontal adduction.



Secondary Outcome Measures :
  1. Pain Questionnaire [ Time Frame: Baseline, 2 weeks, 6 weeks, 3, 6, 12, 24 months ]
    Shoulder pain was assessed using a visual analogue scale (VAS) where zero equals no pain and 10 is the worst possible pain at rest and with activity. Two-way repeated-measures analysis of variance (ANOVA) compared pain between groups over time.

  2. WORC Questionnaire [ Time Frame: Baseline, 6, 12, 24 months ]
    Health related quality of life was measured using the Western Ontario Rotator Cuff Index (WORC). It is a 21-item disease specific questionnaire representing five quality of life domains (physical symptoms, sports and recreation, work, lifestyle and emotions). Each response is marked on a 100mm line in a VAS format with a maximum raw score of 2100, where zero represents the best and 2100 the worst score. This score is transformed to a 0-100 format, with 100 representing full shoulder function.

  3. Abduction Strength Using the Power Component of the Constant Score [ Time Frame: Baseline, 24 months ]
    The Constant Score is the most widely used shoulder evaluation questionnaire in Europe and is a shoulder specific instrument. The score is a combination of an objective physical examination (65 points) and a subjective patient self evaluation (35 points). The physical examination component includes a range of motion assessment (forward elevation, lateral elevation, internal rotation, and external rotation) worth a total of 40 points (maximum of 10 points for each motion). The remaining 25 points are attributed to the strength assessment, where patients are awarded one point for each pound of pull that the patient can resist in abduction. Therefore the total possible score on the Constant score is 100 points (best possible score = 100. In this case only the power component was used therefore the best score is 25.

  4. Complications [ Time Frame: 2 & 6 weeks, 3, 6, 12, 24 months ]
    Incidence of any surgical or medical complications will be prospectively documented.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Clinical:

  • males and females over 18 years of age
  • failed non-operative management defined as persistent pain and/or disability following 3 months of conservative medical treatment including analgesic/anti-inflammatory medications, intra-articular corticosteroids, activity modification and physical therapy.

Radiological:

  • confirmed full-thickness rotator cuff tear on arthrogram or MRI

Surgical:

  • full-thickness tear of the rotator cuff confirmed through arthroscopy
  • rotator cuff repairable using mini-open approach

Exclusion Criteria:

  • previous shoulder surgery
  • previous fracture of scapula or humerus
  • history of charcot joint or inflammatory arthropathy
  • cervical radiculopathy
  • active joint or systemic infection
  • neurological disorder
  • significant paralysis of the rotator cuff, deltoid or shoulder girdle musculature
  • major medical illness (life expectancy less than 2 years or unacceptably high operative risk)
  • unable to speak or read English
  • immunosuppressive therapy or chronic steroids (eg. prednisone)
  • patient unwilling to be followed for 2 years
  • psychiatric illness that precludes informed consent

Information from the National Library of Medicine

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): NCT01741272


Locations
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Canada, Alberta
Grey Nuns Community Hospital
Edmonton, Alberta, Canada, T6L 5X8
Sponsors and Collaborators
Shoulder & Upper Extremity Research Group of Edmonton
Investigators
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Principal Investigator: Robert Balyk, MD, FRCSC University of Alberta
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Responsible Party: Shoulder & Upper Extremity Research Group of Edmonton
ClinicalTrials.gov Identifier: NCT01741272    
Other Study ID Numbers: Pro00001096
First Posted: December 4, 2012    Key Record Dates
Results First Posted: March 17, 2015
Last Update Posted: March 17, 2015
Last Verified: March 2015
Keywords provided by Shoulder & Upper Extremity Research Group of Edmonton:
rotator cuff tear
arthroscopically assisted
health related quality of life(HRQL)
functional outcome
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries