Effectiveness Study of Postoperative Rotator Cuff Repair Rehabilitation

Prospective Randomized Trial of Rotator Cuff Repair Postoperative Rehabilitation: Jackins' Exercises Versus Pulleys

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.

Study Overview

• Status: Completed
• Conditions: Full Thickness Rotator Cuff Tear
• Intervention / Treatment: Procedure: Postoperative Jackins Exercise Protocol; Procedure: Postoperative Pulleys Exercise Protocol

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57117
      • Orthopedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Western Ontario Rotator Cuff Index (WORC)	The WORC(ref 6) is a valid,reliable, and responsive patient-reported outcomes measures that assesses response to treatment for rotator cuff disease. A minimally important clinical difference (MCID) has been determined. Its use has been recommended in clinical trials.	Baseline, 6 weeks, 12 weeks, 6 months, 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in scapular substitution (centimeters)	A novel technique for measuring scapular substitution has been developed by the investigators of this study (Baumgarten et al. Int J Sports Phys Ther. 2012; 7: 39-48).	Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in range of motion (degrees)		Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in strength (N)		Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in Simple Shoulder Test9	The Simple Shoulder Test9 is a self-reported patient outcome score that has been specifically validated to examine post-operative rotator cuff repair outcomes.	Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in American Shoulder and Elbow Surgeon (ASES) Shoulder Score	The ASES Shoulder Score (ref 12) is a self-reported patient outcome score that has been specifically validated to examine rotator cuff disease outcomes. Minimal clinically important differences and the minimal detectable change have been determined.	Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in Marx Shoulder Activity Score2	The Marx Shoulder Activity Score2 is a validated, patient self-reported outcome score that determines activity level. This is a supplement to outcome scores that measure pain and function.	Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in Single Assessment Numeric Evaluation (SANE) rating	The SANE rating (ref 15) is a simple patient self-reported outcome score that asks the patient to rate their shoulder as a percentage of normal (range 0 to 100%).	Baseline, 6 weeks, 12 weeks, 6 months, 1 year

Collaborators and Investigators

• Sponsor: Orthopedic Institute, Sioux Falls, SD
• Investigators: Principal Investigator: Keith M Baumgarten, MD, Orthopedic Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2008
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: December 23, 2012
• First Submitted That Met QC Criteria: March 25, 2013
• First Posted (Estimate): March 28, 2013

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Surgery; Shoulder; Rotator cuff repair; Pulleys; Jackins
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: Jackins