Rotator Cuff TearsNCT02208752
The Effect of a Pre-operative Exercise Program for Patients With Full Thickness Rotator Cuff Tear Waiting for Surgical Repair
A study testing Exercises in people with Rotator Cuff Tears, run by Université de Montréal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients waitng for surgery at Cite de la Sante Hospital
Who cannot join
- Glenohumeral Arthirtis
- Shoulder fracture
- Corticosteriod injections
- Rupture of rotator cuff tear of more than 3 cm
- CSST- Workman's compensation
- Central and peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hôpital Cite-de-la-Santé
Laval, Quebec, H7M 3L9
Mary Caravias, Bachelor, 450-975-5401, mariecaravias@hotmail.com
François Desmeules, Ph. D, 514-343-6791, f.desmeules@umontreal.ca
About this study
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.
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.
Read the 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.
- Conditions
- Rotator Cuff Tears
- Being tested
- Exercises
- Keywords
- rotator cuff tears, ultrasound measure, pain, range of motion, muscle force
- Medical subject headings
- Rotator Cuff Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExercisesOther
exercise program on strengthening the rotator cuff muscles and motor control of the scapula
| Study group | Role | What they receive |
|---|---|---|
| Exercises | Active comparator | exericises on motor control and strengthening exercises on the Rotator Cuff Receives: Other: Exercises |
| Control group- No exercises | Placebo comparator | No exercises Receives: Other: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
WORC questionnaire
To evaluate function and quality of life at 0 weeks and 4 weeks
Measured: 30 days
Secondary outcomes (4)
DASH questionnaire
To evaluate pain at 0 weeks and 4 weeks
Measured: 30 days
Ultrasound measures
Mesurement distance of acromial-humerale distance at 0 and 4 weeks
Measured: 30 days
range of motion
measurement of joint movement (active and passif range of motion) with goniometer at 0 and 4 week
Measured: 30 days
strength
measurement of isometric strength with the Nicolas dynamometer at 0 week and 4 week.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, François Desmeules, Université de Montréal
- Investigators
- François Desmeules, Phd, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208752
- Sponsor's protocol ID
- CARM2014
- Status last verified
- Aug 2014
- First submitted
- 4 Aug 2014
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02208752
- Acronym / sponsor ID
- CARM2014
- Conditions
- Rotator Cuff Tears
- Keywords
- rotator cuff tears, ultrasound measure, pain, range of motion, muscle force
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 5 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercises | Active comparator | Other: Exercisesexericises on motor control and strengthening exercises on the Rotator Cuff |
| Control group- No exercises | Placebo comparator | Other: ExercisesNo exercises |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients waitng for surgery at Cite de la Sante Hospital
Key exclusion criteria (6 listed)
- Glenohumeral Arthirtis
- Shoulder fracture
- Corticosteriod injections
- Rupture of rotator cuff tear of more than 3 cm
- CSST- Workman's compensation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercisesexercise program on strengthening the rotator cuff muscles and motor control of the scapula | Other | Control group- No exercises, Exercises |
Primary outcome
WORC questionnaire
Time frame: 30 days
To evaluate function and quality of life at 0 weeks and 4 weeks
4 secondary outcomes
DASH questionnaire
Time frame: 30 days
Ultrasound measures
Time frame: 30 days
range of motion
Time frame: 30 days
strength
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
Related trials for Rotator Cuff Tears
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
Active, not recruiting
Lyophilized Platelet-Rich Plasma Lysate vs Dextrose Prolotherapy for Partial Rotator Cuff Tears
Rotator Cuff Tear, Rotator Cuff Syndrome
Active, not recruiting
Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair
Rotator Cuff Tear Arthropathy, Repair of a Cuff Tear
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Desmeules, Phd principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises in people with Rotator Cuff Tears, run by Université de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WORC questionnaire (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2014.