Clinical trial NCT01333527: Early Mobilization Following Arthroscopic Rotator Cuff Repair
Official title: Early Mobilization Following Arthroscopic Rotator Cuff Repair: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2011-04-12
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Western Ontario Rotator Cuff Index (WORC)
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
measure: Range of Motion (ROM)
timeFrame: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Secondary outcomes:
measure: Strength
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: The Short Form (36) Health Survey
timeFrame: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
measure: Adverse Events
timeFrame: 2 weeks, 6 weeks, 3 months, 6months
measure: Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
timeFrame: baseline, 6 weeks, 3, 6, 12, 24 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Glen Sather Sports Medicine clinic
state: Alberta
Study officials:
affiliation: University of Alberta
name: David Sheps, MD,MSc,FRCSC
role: PRINCIPAL_INVESTIGATOR
References: