Back to resultsEffectiveness of Technology-enabled Exercise Program in Firefighters With Shoulder Pain.
Primary Purpose
Shoulder Pain
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise Program plus Education
Educational Program (EP).
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain
Eligibility Criteria
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.
Sites / Locations
- Hamilton Fire Station
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise Program plus Education.
Educational Program (EP).
Arm Description
Rotator cuff stretching and strengthening exercises outlined in the American Academy of Orthopedic Surgeons (AAOS) guidelines on management of rotator cuff problems.
An information sheet form AAOS, outlining the anatomy, description, causes, symptoms, examination and imaging tests performed on individuals with shoulder conditions
Outcomes
Primary Outcome Measures
Firefighter Work Limitation Questionnaire
at-work disability and productivity loss
Firefighter Work Limitation Questionnaire
at-work disability and productivity loss
Firefighter Work Limitation Questionnaire
at-work disability and productivity loss
Short- Western Ontario Rotator Cuff Index
Quality of life
Short- Western Ontario Rotator Cuff Index
Quality of life
Short- Western Ontario Rotator Cuff Index
Quality of life
Secondary Outcome Measures
Single Assessment Numeric Evaluation
Patient's perception of the condition
Number of days lost
Work days lost due to the condition
Therapy Adherence Assessment Tool
Exercise adherence
Global Rating of Change Scale
To quantify a patient's improvement or deterioration over time
Adverse Effects
Have you experienced any exercise-induced pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03523884
Brief Title
Effectiveness of Technology-enabled Exercise Program in Firefighters With Shoulder Pain.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2018 (Anticipated)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise Program plus Education.
Arm Type
Experimental
Arm Description
Rotator cuff stretching and strengthening exercises outlined in the American Academy of Orthopedic Surgeons (AAOS) guidelines on management of rotator cuff problems.
Arm Title
Educational Program (EP).
Arm Type
Active Comparator
Arm Description
An information sheet form AAOS, outlining the anatomy, description, causes, symptoms, examination and imaging tests performed on individuals with shoulder conditions
Intervention Type
Other
Intervention Name(s)
Exercise Program plus Education
Other Intervention Name(s)
Exercise and Education
Intervention Description
Rotator cuff exercises outlined in the American Academy of Orthopedic Surgeons (AAOS) guidelines on management of rotator cuff problems.
Intervention Type
Other
Intervention Name(s)
Educational Program (EP).
Other Intervention Name(s)
Education.
Intervention Description
An information sheet form AAOS, outlining the anatomy, description, causes, symptoms, examination and imaging tests performed on individuals with shoulder conditions
Primary Outcome Measure Information:
Title
Firefighter Work Limitation Questionnaire
Description
at-work disability and productivity loss
Time Frame
3-months
Title
Firefighter Work Limitation Questionnaire
Description
at-work disability and productivity loss
Time Frame
6-months
Title
Firefighter Work Limitation Questionnaire
Description
at-work disability and productivity loss
Time Frame
12-months
Title
Short- Western Ontario Rotator Cuff Index
Description
Quality of life
Time Frame
3-months
Title
Short- Western Ontario Rotator Cuff Index
Description
Quality of life
Time Frame
6-months
Title
Short- Western Ontario Rotator Cuff Index
Description
Quality of life
Time Frame
12-months
Secondary Outcome Measure Information:
Title
Single Assessment Numeric Evaluation
Description
Patient's perception of the condition
Time Frame
3-, 6- and 12-months
Title
Number of days lost
Description
Work days lost due to the condition
Time Frame
3-, 6- and 12-months
Title
Therapy Adherence Assessment Tool
Description
Exercise adherence
Time Frame
3-, 6- and 12-months
Title
Global Rating of Change Scale
Description
To quantify a patient's improvement or deterioration over time
Time Frame
6- and 12-months
Title
Adverse Effects
Description
Have you experienced any exercise-induced pain
Time Frame
3-, 6- and 12-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Goris Nazari, PhD(C)
Phone
519 661 2111
Ext
88912
Email
gnazari@uwo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Joy C MacDermid, PhD
Phone
519 661 2111
Ext
88912
Email
jmacderm@uwo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy C MacDermid, PhD
Organizational Affiliation
Western University, jmacderm@uwo.ca, 519 661 2111 x (88912)
Official's Role
Study Chair
Facility Information:
Facility Name
Hamilton Fire Station
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Goris Nazari, PhD (C)
Email
gnazari@uwo.ca
First Name & Middle Initial & Last Name & Degree
Joy C MacDermid, PhD
Phone
519 661 2111
Ext
88912
Email
jmacderm@uwo.ca
First Name & Middle Initial & Last Name & Degree
Goris Nazari, PhD (C)
First Name & Middle Initial & Last Name & Degree
Joy MacDermid, PhD
First Name & Middle Initial & Last Name & Degree
Dianne Bryant, PhD
First Name & Middle Initial & Last Name & Degree
George Athwal, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Technology-enabled Exercise Program in Firefighters With Shoulder Pain.
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