The Effect of a Pre-operative Exercise Program for Patients With Full Thickness Rotator Cuff Tear Waiting for Surgical Repair

August 4, 2014 updated by: François Desmeules, Université de Montréal

The Effect of a Pre-operative Exercise Program on Pain and Function in Patients With Full Thickness Rotator Cuff Tear Waiting for Surgical Repair.

This is a randomised controlled study involving a group of 20 patients- 10 patients in a control group, 10 patients in treatment group. The treatment group consists of exercises with theraband for the shoulder and exercises of motor control of the scapula. The purpose of the study is to measure the effects of a pre-operative physiotherapy program for patients awaitng for rotator cuff surgery, The duration of the pilot project is 4 weeks.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study is taken place in a genral hospital using the waiting list in the orthopedic surgery department- only patients awaitng for rotator cuff surgery are included. a randomised process of a block will be used. There will be 2 groups of patients an active comparator and no intervention. All patients at the beginning of the project and after 4 weks will have an evaluation on range of motion, strength, acromial humeral mesurement done by ultrasound and questionnaire on pain(DASH) and quality of life( WORC). At 8 weeks all patients will fill in the 2 questionnaires on DASH and WORC.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients waitng for surgery at Cite de la Sante Hospital

Exclusion Criteria:

  • Glenohumeral Arthirtis
  • Shoulder fracture
  • Corticosteriod injections
  • Rupture of rotator cuff tear of more than 3 cm
  • CSST- Workman's compensation
  • Central and peripheral neuropathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exercises
exericises on motor control and strengthening exercises on the Rotator Cuff
Other: Exercises
exercise program on strengthening the rotator cuff muscles and motor control of the scapula
Placebo Comparator: Control group- No exercises
No exercises
Other: Exercises
exercise program on strengthening the rotator cuff muscles and motor control of the scapula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WORC questionnaire
Time Frame: 30 days
To evaluate function and quality of life at 0 weeks and 4 weeks
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DASH questionnaire
Time Frame: 30 days
To evaluate pain at 0 weeks and 4 weeks
30 days
Ultrasound measures
Time Frame: 30 days
Mesurement distance of acromial-humerale distance at 0 and 4 weeks
30 days
range of motion
Time Frame: 30 days
measurement of joint movement (active and passif range of motion) with goniometer at 0 and 4 week
30 days
strength
Time Frame: 30 days
measurement of isometric strength with the Nicolas dynamometer at 0 week and 4 week.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Montréal

Investigators

  • Principal Investigator: François Desmeules, Phd, Université de Montréal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

August 4, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimate)

August 5, 2014

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARM2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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