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Effectiveness of Technology-enabled Exercise Program in Firefighters With Shoulder Pain.

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ClinicalTrials.gov Identifier: NCT03523884
Recruitment Status : Not yet recruiting
First Posted : May 14, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Western University, Canada

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.

Condition or disease Intervention/treatment Phase
Shoulder Pain Other: Exercise Program plus Education Other: Educational Program (EP). Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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.
Other: Exercise Program plus Education
Rotator cuff exercises outlined in the American Academy of Orthopedic Surgeons (AAOS) guidelines on management of rotator cuff problems.
Other Name: Exercise and Education

Other: Educational Program (EP).
An information sheet form AAOS, outlining the anatomy, description, causes, symptoms, examination and imaging tests performed on individuals with shoulder conditions
Other Name: Education.

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
Other: Educational Program (EP).
An information sheet form AAOS, outlining the anatomy, description, causes, symptoms, examination and imaging tests performed on individuals with shoulder conditions
Other Name: Education.




Primary Outcome Measures :
  1. Firefighter Work Limitation Questionnaire [ Time Frame: 3-months ]
    at-work disability and productivity loss

  2. Firefighter Work Limitation Questionnaire [ Time Frame: 6-months ]
    at-work disability and productivity loss

  3. Firefighter Work Limitation Questionnaire [ Time Frame: 12-months ]
    at-work disability and productivity loss

  4. Short- Western Ontario Rotator Cuff Index [ Time Frame: 3-months ]
    Quality of life

  5. Short- Western Ontario Rotator Cuff Index [ Time Frame: 6-months ]
    Quality of life

  6. Short- Western Ontario Rotator Cuff Index [ Time Frame: 12-months ]
    Quality of life


Secondary Outcome Measures :
  1. Single Assessment Numeric Evaluation [ Time Frame: 3-, 6- and 12-months ]
    Patient's perception of the condition

  2. Number of days lost [ Time Frame: 3-, 6- and 12-months ]
    Work days lost due to the condition

  3. Therapy Adherence Assessment Tool [ Time Frame: 3-, 6- and 12-months ]
    Exercise adherence

  4. Global Rating of Change Scale [ Time Frame: 6- and 12-months ]
    To quantify a patient's improvement or deterioration over time

  5. Adverse Effects [ Time Frame: 3-, 6- and 12-months ]
    Have you experienced any exercise-induced pain



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523884


Contacts
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Contact: Goris Nazari, PhD(C) 519 661 2111 ext 88912 gnazari@uwo.ca
Contact: Joy C MacDermid, PhD 519 661 2111 ext 88912 jmacderm@uwo.ca

Locations
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Canada, Ontario
Hamilton Fire Station Not yet recruiting
Hamilton, Ontario, Canada
Contact: Goris Nazari, PhD (C)       gnazari@uwo.ca   
Contact: Joy C MacDermid, PhD    519 661 2111 ext 88912    jmacderm@uwo.ca   
Principal Investigator: Goris Nazari, PhD (C)         
Principal Investigator: Joy MacDermid, PhD         
Sub-Investigator: Dianne Bryant, PhD         
Sub-Investigator: George Athwal, PhD         
Sponsors and Collaborators
Western University, Canada
Investigators
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Study Chair: Joy C MacDermid, PhD Western University, jmacderm@uwo.ca, 519 661 2111 x (88912)

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Responsible Party: Western University, Canada
ClinicalTrials.gov Identifier: NCT03523884     History of Changes
Other Study ID Numbers: UWO Firefighters 2018
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms