Overview

This trial is active, not recruiting.

Condition full thickness rotator cuff tear
Treatments postoperative jackins exercise protocol, postoperative pulleys exercise protocol
Sponsor Orthopedic Institute, Sioux Falls, SD
Start date November 2008
End date October 2013
Trial size 56 participants
Trial identifier NCT01819909, Jackins

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
Jackin's exercises were initially designed for patients with difficulty performing forward elevation. The patient initially is positioned supine to perform shoulder flexion. When the patient can actively elevate in the supine position, one to two pounds of weight is placed in the patients hand and the patient is asked to repeat the maneuver of supine active elevation. When the patient can do this with little difficulty, the head of the bed is elevated approximately 20 degrees from the supine position and the sequence is repeated. Once the patient is able to perform flexion in this elevated head position, the inclination of the patient is increased in 20 degree increments until the patient is able to perform upright sitting shoulder flexion.
postoperative jackins exercise protocol
Jackin's exercises were initially designed for patients with difficulty performing forward elevation. The patient initially is positioned supine to perform shoulder flexion. When the patient can actively elevate in the supine position, one to two pounds of weight is placed in the patients hand and the patient is asked to repeat the maneuver of supine active elevation. When the patient can do this with little difficulty, the head of the bed is elevated approximately 20 degrees from the supine position and the sequence is repeated. Once the patient is able to perform flexion in this elevated head position, the inclination of the patient is increased in 20 degree increments until the patient is able to perform upright sitting shoulder flexion.
(Experimental)
Pulleys have been used in postoperative shoulder rehabilitation to improve passive as well as active range of motion and develop strength.
postoperative pulleys exercise protocol
Pulleys have been used in postoperative shoulder rehabilitation to improve passive as well as active range of motion and develop strength.

Primary Outcomes

Measure
Change in Western Ontario Rotator Cuff Index (WORC)
time frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year

Secondary Outcomes

Measure
Change in scapular substitution (centimeters)
time frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in range of motion (degrees)
time frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in strength (N)
time frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in Simple Shoulder Test9
time frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in American Shoulder and Elbow Surgeon (ASES) Shoulder Score
time frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in Marx Shoulder Activity Score2
time frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in Single Assessment Numeric Evaluation (SANE) rating
time frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Prospective Randomized Trial of Rotator Cuff Repair Postoperative Rehabilitation: Jackins' Exercises Versus Pulleys
Principal investigator Keith M Baumgarten, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Orthopedic Institute, Sioux Falls, SD.