NCT02208752

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

3 months

First QC Date

August 4, 2014

Last Update Submit

August 4, 2014

Conditions

Rotator Cuff Tears

Keywords

rotator cuff tearsultrasound measurepainrange of motionmuscle force

Outcome Measures

Primary Outcomes (1)

  • WORC questionnaire

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

    30 days

Secondary Outcomes (4)

  • DASH questionnaire

    30 days

  • Ultrasound measures

    30 days

  • range of motion

    30 days

  • strength

    30 days

Study Arms (2)

Exercises

ACTIVE COMPARATOR

exericises on motor control and strengthening exercises on the Rotator Cuff

Other: Exercises

Control group- No exercises

PLACEBO COMPARATOR

No exercises

Other: Exercises

Interventions

ExercisesOTHER

exercise program on strengthening the rotator cuff muscles and motor control of the scapula

Control group- No exercisesExercises

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients waitng for surgery at Cite de la Sante Hospital

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cite-de-la-Santé

Laval, Quebec, H7M 3L9, Canada

RECRUITING

MeSH Terms

Conditions

Rotator Cuff InjuriesPain

Interventions

Exercise

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • François Desmeules, Phd

    Université de Montréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal researcher

Study Record Dates

First Submitted

August 4, 2014

First Posted

August 5, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

August 5, 2014

Record last verified: 2014-08

Locations

CA(1)