Rehabilitation of Reconstructed Shoulder Rotator Cuff

Rehabilitation of Reconstructed Shoulder Rotator Cuff : Optimizing Physical Therapy Dosage and Effect of Aquatic Physical Therapy - A Randomized, Factorial Study

The aim of this study to define the optimal rehabilitation for clients with full thickness rotator cuff reconstruction, with two goals: 1. Finding the optimal physical therapy dosage in enhancing post-operative outcomes of shoulder pain, shoulder joint range of motion, shoulder muscle strength, upper extremity function; and 2. Finding the effect of aquatic physical therapy in enhancing the post-operative outcomes.

Study Overview

• Status: Completed
• Conditions: Full Thickness Rotator Cuff Tear
• Intervention / Treatment: Procedure: Standard physical therapy program PLUS aquatic physical therapy; Other: standard care

Detailed Description

Measurement devices:

Biodex: Biodex system is a muscle strength testing and rehabilitation instrument used in the testing and rehabilitation services for shoulder, elbow, wrist, hip, knee and ankle. Modes of operation for exercise and testing include isokinetic, passive, isometric, isotonic, and reactive eccentric. Patients are tested for their muscle performance for the required number of repetitions in the required mode. The muscle performance is measured by calculating the average peak torque (in Nm) and analyzed across the group of patients.

Goniometer: A manual devise used to measure joint range of motion. Visual Analogue Scale: A scale with 0 to 10, with 0 being no pain, and 10 being severe pain.

Measurement procedure:

All the subjects posted for surgery will be tested prior to and again 6 weeks following surgery for:

Shoulder Pain is measured using a visual analog scale. Shoulder Range of motion is measured using a standard goniometer. Shoulder Muscle performances are measured using Biodex.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • St Joseph's health Care London

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:

• full thickness rotator cuff tear treated by arthroscopic or mini-open repair by a specialized upper extremity surgeons
• mentally competent
• able to read and write
• able to return for follow-up
• 18-65 years old

Exclusion Criteria:

• associated surgical procedures (Concomitant fractures, capsular releases surgical decompression)
• nerve injury
• neurological conditions
• irreparable massive rotator cuff tear, and
• comorbid health problems that limit rehabilitation potential (Rheumatoid arthritis, Diabetes).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard care
Experimental: aquatic physical therapy; aquatic physical therapy program which will be conducted twice weekly for 10 weeks and will include a 40-50 minute hydrotherapy session emphasizing range of motion and light resistive exercises of the arm, primarily focussing on the shoulder.	Procedure: Standard physical therapy program PLUS aquatic physical therapy; 2. Standard physical therapy program PLUS aquatic physical therapy: The above PLUS a aquatic physical therapy program which will be conducted twice weekly for 10 weeks and will include a 40-50 minute hydrotherapy session emphasizing range of motion and light resistive exercises of the arm, primarily focusing on the shoulder. The program will start with general mobility of the other upper limb joints to allow time for preconditioning of the painful shoulder. Shoulder exercises will emphasize flexion, rotation and abduction and a slow transition from pain-free range to the restricted range of motion to maximize the effectiveness of the heat and buoyancy.; Other: standard care; Total of 12 weeks; each exercise session will be 20 -30 minutes of direct contact and additional supervised exercise as defined by assignment and stage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
strength	3 month after the surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
patient satisfaction	3 and 6 months after the surgery

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Joy MacDernmid, PhD, St. Joseph's Health Care London

Publications and helpful links

General Publications

• Roddey TS, Olson SL, Gartsman GM, Hanten WP, Cook KF. A randomized controlled trial comparing 2 instructional approaches to home exercise instruction following arthroscopic full-thickness rotator cuff repair surgery. J Orthop Sports Phys Ther. 2002 Nov;32(11):548-59. doi: 10.2519/jospt.2002.32.11.548.
• Ellenbecker TS, Sueyoshi T, Winters M, Zeman D. Descriptive report of shoulder range of motion and rotational strength six and 12 weeks following arthroscopic superior labral repair. N Am J Sports Phys Ther. 2008 May;3(2):95-106.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: December 19, 2011
• First Submitted That Met QC Criteria: December 23, 2011
• First Posted (Estimate): December 26, 2011

Study Record Updates

• Last Update Posted (Estimate): March 19, 2014
• Last Update Submitted That Met QC Criteria: March 18, 2014
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Physiotherapy; Rotator cuff tear; Shoulder rehabilitation; aqua therapy; Therapy dosage; adjunctive aquatic physical therapy
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 18466