Clinical trial NCT01819909: Effectiveness Study of Postoperative Rotator Cuff Repair Rehabilitation
Official title: Prospective Randomized Trial of Rotator Cuff Repair Postoperative Rehabilitation: Jackins' Exercises Versus Pulleys
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Full Thickness Rotator Cuff Tear
Keywords: Rotator cuff repair
Shoulder
Surgery
Rehabilitation
Pulleys
Jackins
Lead sponsor: Orthopedic Institute, Sioux Falls, SD
Sponsor class: OTHER
First posted: 2013-03-28
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are very few level 1 or level 2 evidence studies that examine postoperative rehabilitation of rotator cuff repair and shoulder arthroplasty. A systematic review of level 1 or level 2 evidence studies was performed (Baumgarten et al., Sports Health, 2009) that found only four studies that examined rotator cuff repair rehabilitation.

The current study was performed to determine if there is a significant difference in passive glenohumeral joint range of motion, active glenohumeral joint range of motion, scapular substitution, and subjects measured outcome scores (clinimetrics) in patients who undergo rotator cuff repair when treated postoperatively with pulley exercises compared to Jackins' exercises.

Null Hypothesis: There will be no significant difference in passive range of motion, active range of motion, scapular substitution, and subject measured outcomes scores in subjects who undergo rotator cuff repair when treated with pulley exercises compared to Jackins' exercises.

Detailed description: Scapulothoracic substitution for forward elevation is seen clinically when patients have shoulder pain. The patient uses the trapezius musculature to superiorly elevate the upper extremity instead of using the deltoid and the rotator cuff for upper extremity elevation. Scapulothoracic substitution does not occur in healthy shoulders. Excessive scapular movement can be due to an attempt to substitute for poorly functioning shoulder musculature or tightness of the capsular structures of the glenohumeral joint.

Pulleys have been used in postoperative shoulder rehabilitation to improve passive as well as active range of motion and develop strength. Jackins described a series of exercises that are used to improve active range of motion and develop strength without the use of pulleys. The use of pulleys in the post-operative care for patients who have had shoulder surgery is thought to contribute to excessive scapular motion. To date, there has not been any study that compares the use of pulleys and Jackins' exercises with respect to active range of motion, scapulothoracic substitution, and objective patient outcomes measures. Due to the lack of level 1 or 2 evidence postoperative rehabilitation studies, a prospective randomized study should be performed on patients that have underwent rotator cuff repair.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing post-operative rehabilitation for a rotator cuff repair

Exclusion Criteria:

* Patients who do not have permission from their treating surgeon to enroll in this study.

Patients who have undergone a previous rotator cuff repair on the non-operated side.

Patients who have undergone a previous rotator cuff repair on the ipsilateral shoulder.

Patients who have a history of adhesive capsulitis. Patients who are unwilling to participate in all aspects of the study. Patients who are cognitively impaired. Patients with known axillary or suprascapular neuropathy. Patients with a painful or dysfunctional contralateral shoulder.

Primary outcomes:
measure: Change in Western Ontario Rotator Cuff Index (WORC)
timeFrame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Secondary outcomes:
measure: Change in scapular substitution (centimeters)
timeFrame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
measure: Change in range of motion (degrees)
timeFrame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
measure: Change in strength (N)
timeFrame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
measure: Change in Simple Shoulder Test9
timeFrame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
measure: Change in American Shoulder and Elbow Surgeon (ASES) Shoulder Score
timeFrame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
measure: Change in Marx Shoulder Activity Score2
timeFrame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
measure: Change in Single Assessment Numeric Evaluation (SANE) rating
timeFrame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Orthopedic Institute
state: South Dakota
Study officials:
affiliation: Orthopedic Institute
name: Keith M Baumgarten, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baumgarten KM, Osborn R, Schweinle WE Jr, Zens MJ, Helsper EA. Are Pulley Exercises Initiated 6 Weeks After Rotator Cuff Repair a Safe and Effective Rehabilitative Treatment? A Randomized Controlled Trial. Am J Sports Med. 2016 Jul;44(7):1844-51. doi: 10.1177/0363546516640763. Epub 2016 Apr 26.