- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01333527
Early Mobilization Following Arthroscopic Rotator Cuff Repair
Early Mobilization Following Arthroscopic Rotator Cuff Repair: a Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2H9
- Glen Sather Sports Medicine clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient is over 18 years of age
- Patient has attempted non-operative treatment (i.e. physical therapy consisting of progressive ROM, strengthening, and postural exercises)
- Patient has a 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 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
- Surgeon or patient has decided to cancel surgery
- Surgeon concludes that an arthroscopic repair is not appropriate at time of surgery (based on RC tear characteristics or concomitant shoulder pathology)
- Patient unwilling to complete necessary follow-ups
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A (early ROM)
Group A (early ROM) will use the sling for comfort only
|
Early range of motion
|
Active Comparator: Group B (usual care)
Group B (usual care) will be immobilized in a sling for 6 weeks.
|
Patients will use the sling for 6 weeks, as per usual care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Western Ontario Rotator Cuff Index (WORC)
Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
|
a 5-part (physical symptoms, sports/recreation, work, lifestyle, emotions) 21-item disease specific questionnaire.
Measured in percentage.
0% = worst, 100 % = best
|
Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
|
Range of Motion (ROM)
Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
|
Measured flexion, abduction, external rotation in 90 degrees abduction [ER(90)], internal rotation in 90 degrees abduction [IR(90)], horizontal adduction, scaption, degrees with a goniometer by the same tester throughout
|
baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Strength
Time Frame: Baseline, 6 months, 12 months, 24 months
|
strength was measured in pounds of force using a dynamometer (microFET3, Hoggan Health Industries, West Jordan, UT).
Isometric shoulder flexion, abduction, were measured with the arm in neutral abduction and elbow at 90 degrees flexion.
External and internal rotation were measured in 90 degrees of abduction.
Peak values were recorded during each contraction which was held for 3 seconds.
Values were expressed as raw values.
|
Baseline, 6 months, 12 months, 24 months
|
The Short Form (36) Health Survey
Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
|
The Short Form (36) Health Survey is a quality of life questionnaire that looks at eight scales: physical functioning, Role-physical, bodily pain, general health, vitality, social function, role-emotional, mental health.
Each scale ranges between 0 (completely disable) to 100 (completely able).
|
baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
|
Adverse Events
Time Frame: 2 weeks, 6 weeks, 3 months, 6months
|
The following complications were monitored throughout study:
The surgeon responsible for the patient used clinical judgment to make a decision regarding if the complication was related or not to the treatment being tested (use or not of sling). |
2 weeks, 6 weeks, 3 months, 6months
|
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Time Frame: baseline, 6 weeks, 3, 6, 12, 24 months
|
Shoulder pain at rest, with activity and at night were measured using a visual analogue scale of 0-10 (no pain to severe pain)
|
baseline, 6 weeks, 3, 6, 12, 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Sheps, MD,MSc,FRCSC, University of Alberta
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RES0005824
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rotator Cuff Tear
-
Bezmialem Vakif UniversityNot yet recruitingRotator Cuff Tears | Partial Tear of Rotator CuffTurkey
-
Keele UniversityUniversity Hospitals, Leicester; Liverpool University Hospitals NHS Foundation... and other collaboratorsWithdrawnTraumatic Rotator Cuff TearUnited Kingdom
-
Rush University Medical CenterSmith & Nephew, Inc.CompletedRotator Cuff Tear Repair Anchors
-
University of MichiganCompletedFull Thickness Rotator Cuff Tear
-
Johannes Kepler University of LinzCompletedFull Thickness Rotator Cuff TearAustria
-
Lawson Health Research InstituteCompleted
-
Orthofix Inc.TerminatedPEMF as Adjunctive Treatment Following Surgical Repair of Full Thickness Rotator Cuff Tears (RCStim)Full-thickness Rotator Cuff TearUnited States
-
InGeneron, Inc.CompletedRotator Cuff Tear - Partial ThicknessUnited States
-
Izmir Katip Celebi UniversityTerminatedPartial Thickness Rotator Cuff TearTurkey
-
BioMimetic TherapeuticsCompletedFull Thickness Rotator Cuff TearCanada
Clinical Trials on No Sling
-
Christiana Care Health ServicesTerminated
-
University of AlbertaCompleted
-
University Hospitals Cleveland Medical CenterRecruiting
-
American Medical SystemsCompletedUrinary Incontinence, StressCanada, United States
-
Federal University of São PauloCompletedFemale Stress Urinary IncontinenceBrazil
-
Istanbul Physical Medicine Rehabilitation Training...CompletedRehabilitation | HemiplegiaTurkey
-
Stanford UniversityWithdrawn
-
Orthopedic Institute, Sioux Falls, SDRecruitingRotator Cuff Tears | Osteo Arthritis ShouldersUnited States
-
Hospital Universitari Vall d'Hebron Research InstituteInstitut d'Investigació Biomèdica de Girona Dr. Josep Trueta; Hospital Universitari... and other collaboratorsCompletedFemale Stress Urinary IncontinenceSpain