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

Primary Purpose

Rotator Cuff Tears

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercises
Sponsored by
Université de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears focused on measuring rotator cuff tears, ultrasound measure, pain, range of motion, muscle force

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hôpital Cite-de-la-SantéRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Exercises

Control group- No exercises

Arm Description

exericises on motor control and strengthening exercises on the Rotator Cuff

No exercises

Outcomes

Primary Outcome Measures

WORC questionnaire
To evaluate function and quality of life at 0 weeks and 4 weeks

Secondary Outcome Measures

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

Full Information

First Posted
August 4, 2014
Last Updated
August 4, 2014
Sponsor
Université de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT02208752
Brief Title
The Effect of a Pre-operative Exercise Program for Patients With Full Thickness Rotator Cuff Tear Waiting for Surgical Repair
Official Title
The Effect of a Pre-operative Exercise Program on Pain and Function in Patients With Full Thickness Rotator Cuff Tear Waiting for Surgical Repair.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
Keywords
rotator cuff tears, ultrasound measure, pain, range of motion, muscle force

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercises
Arm Type
Active Comparator
Arm Description
exericises on motor control and strengthening exercises on the Rotator Cuff
Arm Title
Control group- No exercises
Arm Type
Placebo Comparator
Arm Description
No exercises
Intervention Type
Other
Intervention Name(s)
Exercises
Intervention Description
exercise program on strengthening the rotator cuff muscles and motor control of the scapula
Primary Outcome Measure Information:
Title
WORC questionnaire
Description
To evaluate function and quality of life at 0 weeks and 4 weeks
Time Frame
30 days
Secondary Outcome Measure Information:
Title
DASH questionnaire
Description
To evaluate pain at 0 weeks and 4 weeks
Time Frame
30 days
Title
Ultrasound measures
Description
Mesurement distance of acromial-humerale distance at 0 and 4 weeks
Time Frame
30 days
Title
range of motion
Description
measurement of joint movement (active and passif range of motion) with goniometer at 0 and 4 week
Time Frame
30 days
Title
strength
Description
measurement of isometric strength with the Nicolas dynamometer at 0 week and 4 week.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Desmeules, Phd
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Cite-de-la-Santé
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7M 3L9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Caravias, Bachelor
Phone
450-975-5401
Email
mariecaravias@hotmail.com
First Name & Middle Initial & Last Name & Degree
François Desmeules, Ph. D
Phone
514-343-6791
Email
f.desmeules@umontreal.ca

12. IPD Sharing Statement

Learn more about this trial

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

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