- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03523884
Effectiveness of Technology-enabled Exercise Program in Firefighters With Shoulder Pain.
May 1, 2018 updated by: Western University, Canada
Development of A Technology-Enabled Intervention for Musculoskeletal Health: The Effectiveness of Technology-enabled Exercise Program in Firefighters With Shoulder Pain. A Randomized Controlled Trial.
To assess if a technology-enabled Exercise program plus Education (TEEP + E) is more effective than Education program (EP) alone, in providing better outcomes (quality of life, at-work disability and productivity loss, firefighters' perception, adherence, overall improvement/deterioration) in firefighters with shoulder pain, at 3-, 6-and 12-month follow ups.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
180
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 Contact
- Name: Goris Nazari, PhD(C)
- Phone Number: 88912 519 661 2111
- Email: gnazari@uwo.ca
Study Contact Backup
- Name: Joy C MacDermid, PhD
- Phone Number: 88912 519 661 2111
- Email: jmacderm@uwo.ca
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada
- Hamilton Fire Station
-
Principal Investigator:
- Joy MacDermid, PhD
-
Contact:
- Joy C MacDermid, PhD
- Phone Number: 88912 519 661 2111
- Email: jmacderm@uwo.ca
-
Contact:
- Goris Nazari, PhD (C)
- Email: gnazari@uwo.ca
-
Principal Investigator:
- Goris Nazari, PhD (C)
-
Sub-Investigator:
- George Athwal, PhD
-
-
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
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Active duty firefighters aged 18 to 100 years, with shoulder pain.
- Do not permanently use strong pain medications.
- Able to understand spoken and written English.
- Access to computer, internet and telecommunications application software (Skype).
Exclusion Criteria:
- Firefighters who have had shoulder related surgeries in the last 6 months.
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise Program plus Education.
Rotator cuff stretching and strengthening exercises outlined in the American Academy of Orthopedic Surgeons (AAOS) guidelines on management of rotator cuff problems.
|
Rotator cuff exercises outlined in the American Academy of Orthopedic Surgeons (AAOS) guidelines on management of rotator cuff problems.
Other Names:
An information sheet form AAOS, outlining the anatomy, description, causes, symptoms, examination and imaging tests performed on individuals with shoulder conditions
Other Names:
|
Active Comparator: Educational Program (EP).
An information sheet form AAOS, outlining the anatomy, description, causes, symptoms, examination and imaging tests performed on individuals with shoulder conditions
|
An information sheet form AAOS, outlining the anatomy, description, causes, symptoms, examination and imaging tests performed on individuals with shoulder conditions
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Firefighter Work Limitation Questionnaire
Time Frame: 3-months
|
at-work disability and productivity loss
|
3-months
|
Firefighter Work Limitation Questionnaire
Time Frame: 6-months
|
at-work disability and productivity loss
|
6-months
|
Firefighter Work Limitation Questionnaire
Time Frame: 12-months
|
at-work disability and productivity loss
|
12-months
|
Short- Western Ontario Rotator Cuff Index
Time Frame: 3-months
|
Quality of life
|
3-months
|
Short- Western Ontario Rotator Cuff Index
Time Frame: 6-months
|
Quality of life
|
6-months
|
Short- Western Ontario Rotator Cuff Index
Time Frame: 12-months
|
Quality of life
|
12-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Single Assessment Numeric Evaluation
Time Frame: 3-, 6- and 12-months
|
Patient's perception of the condition
|
3-, 6- and 12-months
|
Number of days lost
Time Frame: 3-, 6- and 12-months
|
Work days lost due to the condition
|
3-, 6- and 12-months
|
Therapy Adherence Assessment Tool
Time Frame: 3-, 6- and 12-months
|
Exercise adherence
|
3-, 6- and 12-months
|
Global Rating of Change Scale
Time Frame: 6- and 12-months
|
To quantify a patient's improvement or deterioration over time
|
6- and 12-months
|
Adverse Effects
Time Frame: 3-, 6- and 12-months
|
Have you experienced any exercise-induced pain
|
3-, 6- and 12-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Joy C MacDermid, PhD, Western University, jmacderm@uwo.ca, 519 661 2111 x (88912)
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 (Anticipated)
June 1, 2018
Primary Completion (Anticipated)
June 1, 2019
Study Completion (Anticipated)
September 1, 2019
Study Registration Dates
First Submitted
April 11, 2018
First Submitted That Met QC Criteria
May 1, 2018
First Posted (Actual)
May 14, 2018
Study Record Updates
Last Update Posted (Actual)
May 14, 2018
Last Update Submitted That Met QC Criteria
May 1, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UWO Firefighters 2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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