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Effectiveness Study of Postoperative Rotator Cuff Repair Rehabilitation

Primary Purpose

Full Thickness Rotator Cuff Tear

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Postoperative Jackins Exercise Protocol
Postoperative Pulleys Exercise Protocol
Sponsored by
Orthopedic Institute, Sioux Falls, SD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Full Thickness Rotator Cuff Tear focused on measuring Rotator cuff repair, Shoulder, Surgery, Rehabilitation, Pulleys, Jackins

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Orthopedic Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Postoperative Jackins Exercise Protocol

Postoperative Pulleys Exercise Protocol

Arm Description

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.

Pulleys have been used in postoperative shoulder rehabilitation to improve passive as well as active range of motion and develop strength.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Change in range of motion (degrees)
Change in strength (N)
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.
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.
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.
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%).

Full Information

First Posted
December 23, 2012
Last Updated
February 28, 2022
Sponsor
Orthopedic Institute, Sioux Falls, SD
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1. Study Identification

Unique Protocol Identification Number
NCT01819909
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 2008 (Actual)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Orthopedic Institute, Sioux Falls, SD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Full Thickness Rotator Cuff Tear
Keywords
Rotator cuff repair, Shoulder, Surgery, Rehabilitation, Pulleys, Jackins

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Postoperative Jackins Exercise Protocol
Arm Type
Experimental
Arm Description
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.
Arm Title
Postoperative Pulleys Exercise Protocol
Arm Type
Experimental
Arm Description
Pulleys have been used in postoperative shoulder rehabilitation to improve passive as well as active range of motion and develop strength.
Intervention Type
Procedure
Intervention Name(s)
Postoperative Jackins Exercise Protocol
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Postoperative Pulleys Exercise Protocol
Intervention Description
Pulleys have been used in postoperative shoulder rehabilitation to improve passive as well as active range of motion and develop strength.
Primary Outcome Measure Information:
Title
Change in Western Ontario Rotator Cuff Index (WORC)
Description
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.
Time Frame
Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Secondary Outcome Measure Information:
Title
Change in scapular substitution (centimeters)
Description
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).
Time Frame
Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Title
Change in range of motion (degrees)
Time Frame
Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Title
Change in strength (N)
Time Frame
Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Title
Change in Simple Shoulder Test9
Description
The Simple Shoulder Test9 is a self-reported patient outcome score that has been specifically validated to examine post-operative rotator cuff repair outcomes.
Time Frame
Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Title
Change in American Shoulder and Elbow Surgeon (ASES) Shoulder Score
Description
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.
Time Frame
Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Title
Change in Marx Shoulder Activity Score2
Description
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.
Time Frame
Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Title
Change in Single Assessment Numeric Evaluation (SANE) rating
Description
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%).
Time Frame
Baseline, 6 weeks, 12 weeks, 6 months, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith M Baumgarten, MD
Organizational Affiliation
Orthopedic Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopedic Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27159310
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.
Results Reference
derived

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Effectiveness Study of Postoperative Rotator Cuff Repair Rehabilitation

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