NCT03523884

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.

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
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

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

First Submitted

Initial submission to the registry

April 11, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 14, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

May 14, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

April 11, 2018

Last Update Submit

May 1, 2018

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (6)

  • Firefighter Work Limitation Questionnaire

    at-work disability and productivity loss

    3-months

  • Firefighter Work Limitation Questionnaire

    at-work disability and productivity loss

    6-months

  • Firefighter Work Limitation Questionnaire

    at-work disability and productivity loss

    12-months

  • Short- Western Ontario Rotator Cuff Index

    Quality of life

    3-months

  • Short- Western Ontario Rotator Cuff Index

    Quality of life

    6-months

  • Short- Western Ontario Rotator Cuff Index

    Quality of life

    12-months

Secondary Outcomes (5)

  • Single Assessment Numeric Evaluation

    3-, 6- and 12-months

  • Number of days lost

    3-, 6- and 12-months

  • Therapy Adherence Assessment Tool

    3-, 6- and 12-months

  • Global Rating of Change Scale

    6- and 12-months

  • Adverse Effects

    3-, 6- and 12-months

Study Arms (2)

Exercise Program plus Education.

EXPERIMENTAL

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 EducationOther: Educational Program (EP).

Educational Program (EP).

ACTIVE COMPARATOR

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).

Interventions

Exercise Program plus EducationOTHER

Rotator cuff exercises outlined in the American Academy of Orthopedic Surgeons (AAOS) guidelines on management of rotator cuff problems.

Also known as: Exercise and Education
Exercise Program plus Education.
Educational Program (EP).OTHER

An information sheet form AAOS, outlining the anatomy, description, causes, symptoms, examination and imaging tests performed on individuals with shoulder conditions

Also known as: Education.
Educational Program (EP).Exercise Program plus Education.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Firefighters who have had shoulder related surgeries in the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Fire Station

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Educational StatusExercise

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Joy C MacDermid, PhD

    Western University, jmacderm@uwo.ca, 519 661 2111 x (88912)

    STUDY CHAIR

Central Study Contacts

Goris Nazari, PhD(C)

CONTACT

519 661 2111gnazari@uwo.ca

Joy C MacDermid, PhD

CONTACT

519 661 2111jmacderm@uwo.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2018

First Posted

May 14, 2018

Study Start

June 1, 2018

Primary Completion

June 1, 2019

Study Completion

September 1, 2019

Last Updated

May 14, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)