Effectiveness Study of Postoperative Rotator Cuff Repair Rehabilitation

NCT01819909 | Completed

• 1 other identifier: Jackins
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Full Thickness Rotator Cuff Tear

Keywords

Rotator cuff repair; Shoulder; Surgery; Rehabilitation; Pulleys; Jackins

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in scapular substitution (centimeters)

  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

  Baseline, 6 weeks, 12 weeks, 6 months, 1 year

• Change in American Shoulder and Elbow Surgeon (ASES) Shoulder Score

  Baseline, 6 weeks, 12 weeks, 6 months, 1 year

Study Arms (2)

Postoperative Jackins Exercise Protocol

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.

Procedure: Postoperative Jackins Exercise Protocol

Postoperative Pulleys Exercise Protocol

EXPERIMENTAL

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

Interventions

Postoperative Jackins Exercise Protocol PROCEDURE

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

Postoperative Pulleys Exercise Protocol PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orthopedic Institute, Sioux Falls, SD: lead

Study Sites (1)

Orthopedic Institute

Sioux Falls, South Dakota, 57117, United States

Location

Related Publications (1)

• 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.

  PMID: 27159310 DERIVED

Study Officials

• Keith M Baumgarten, MD

  Orthopedic Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 23, 2012
• First Posted: March 28, 2013
• Study Start: November 1, 2008
• Primary Completion: October 1, 2015
• Study Completion: July 1, 2016
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

US (1)