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Effectiveness Study of Postoperative Rotator Cuff Repair Rehabilitation

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ClinicalTrials.gov Identifier: NCT01819909
Recruitment Status : Unknown
Verified March 2013 by Keith Baumgarten, Orthopedic Institute, Sioux Falls, SD.
Recruitment status was:  Active, not recruiting
First Posted : March 28, 2013
Last Update Posted : March 28, 2013
Sponsor:
Information provided by (Responsible Party):
Keith Baumgarten, Orthopedic Institute, Sioux Falls, SD

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.


Condition or disease Intervention/treatment Phase
Full Thickness Rotator Cuff Tear Procedure: Postoperative Jackins Exercise Protocol Procedure: Postoperative Pulleys Exercise Protocol Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Rotator Cuff Repair Postoperative Rehabilitation: Jackins' Exercises Versus Pulleys
Study Start Date : November 2008
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in Western Ontario Rotator Cuff Index (WORC) [ Time Frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year ]
    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 :
  1. Change in scapular substitution (centimeters) [ Time Frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year ]
    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).

  2. Change in range of motion (degrees) [ Time Frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year ]
  3. Change in strength (N) [ Time Frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year ]
  4. Change in Simple Shoulder Test9 [ Time Frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year ]
    The Simple Shoulder Test9 is a self-reported patient outcome score that has been specifically validated to examine post-operative rotator cuff repair outcomes.

  5. Change in American Shoulder and Elbow Surgeon (ASES) Shoulder Score [ Time Frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year ]
    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.

  6. Change in Marx Shoulder Activity Score2 [ Time Frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year ]
    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.

  7. Change in Single Assessment Numeric Evaluation (SANE) rating [ Time Frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year ]
    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%).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819909


Locations
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United States, South Dakota
Orthopedic Institute
Sioux Falls, South Dakota, United States, 57117
Sponsors and Collaborators
Orthopedic Institute, Sioux Falls, SD
Investigators
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Principal Investigator: Keith M Baumgarten, MD Orthopedic Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Keith Baumgarten, MD, Orthopedic Institute, Sioux Falls, SD
ClinicalTrials.gov Identifier: NCT01819909     History of Changes
Other Study ID Numbers: Jackins
First Posted: March 28, 2013    Key Record Dates
Last Update Posted: March 28, 2013
Last Verified: March 2013

Keywords provided by Keith Baumgarten, Orthopedic Institute, Sioux Falls, SD:
Rotator cuff repair
Shoulder
Surgery
Rehabilitation
Pulleys
Jackins

Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries