Shoulder PainNCT03523884
Effectiveness of Technology-enabled Exercise Program in Firefighters With Shoulder Pain.
A study testing Exercise Program plus Education and Educational Program (EP). in people with Shoulder Pain, run by Western University, Canada at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Exercise Program plus Education and Educational Program (EP).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2018to Sep 2019
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Firefighters who have had shoulder related surgeries in the last 6 months.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton Fire Station
Hamilton, Ontario
Goris Nazari, PhD (C), gnazari@uwo.ca
Joy C MacDermid, PhD, 519 661 2111 ext. 88912, jmacderm@uwo.ca
About this study
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.
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.
- Conditions
- Shoulder Pain
- Being tested
- Exercise Program plus Education, Educational Program (EP).
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Program plus EducationOther
Also called Exercise and Education
Rotator cuff exercises outlined in the American Academy of Orthopedic Surgeons (AAOS) guidelines on management of rotator cuff problems.
Educational Program (EP).Other
Also called Education.
An information sheet form AAOS, outlining the anatomy, description, causes, symptoms, examination and imaging tests performed on individuals with shoulder conditions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise Program plus Education; Other: 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 Receives: Other: Educational Program (EP). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Firefighter Work Limitation Questionnaire
at-work disability and productivity loss
Measured: 3-months
Firefighter Work Limitation Questionnaire
at-work disability and productivity loss
Measured: 6-months
Firefighter Work Limitation Questionnaire
at-work disability and productivity loss
Measured: 12-months
Short- Western Ontario Rotator Cuff Index
Quality of life
Measured: 3-months
Short- Western Ontario Rotator Cuff Index
Quality of life
Measured: 6-months
Short- Western Ontario Rotator Cuff Index
Quality of life
Measured: 12-months
Secondary outcomes (5)
Single Assessment Numeric Evaluation
Patient's perception of the condition
Measured: 3-, 6- and 12-months
Number of days lost
Work days lost due to the condition
Measured: 3-, 6- and 12-months
Therapy Adherence Assessment Tool
Exercise adherence
Measured: 3-, 6- and 12-months
Global Rating of Change Scale
To quantify a patient's improvement or deterioration over time
Measured: 6- and 12-months
Adverse Effects
Have you experienced any exercise-induced pain
Measured: 3-, 6- and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study startJun 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joy C MacDermid, PhD, Study chair, Western University, jmacderm@uwo.ca, 519 661 2111 x (88912)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523884
- Sponsor's protocol ID
- UWO Firefighters 2018
- Status last verified
- Apr 2018
- First submitted
- 11 Apr 2018
- Last updated
- 14 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03523884
- Acronym / sponsor ID
- UWO Firefighters 2018
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 14 May 2018 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Program plus Education. | Experimental | Other: Exercise Program plus Education, Other: Educational Program (EP).Rotator cuff stretching and strengthening exercises outlined in the American Academy of Orthopedic Surgeons (AAOS) guidelines on management of rotator cuff problems. |
| Educational Program (EP). | Active comparator | 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- Firefighters who have had shoulder related surgeries in the last 6 months.
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 |
|---|---|---|
| Exercise Program plus EducationAlso: Exercise and EducationRotator cuff exercises outlined in the American Academy of Orthopedic Surgeons (AAOS) guidelines on management of rotator cuff problems. | Other | Exercise Program plus Education. |
| Educational Program (EP).Also: Education.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)., Exercise Program plus Education. |
Primary outcome
Firefighter Work Limitation Questionnaire
Time frame: 3-months
at-work disability and productivity loss
Firefighter Work Limitation Questionnaire
Time frame: 6-months
at-work disability and productivity loss
Firefighter Work Limitation Questionnaire
Time frame: 12-months
at-work disability and productivity loss
Short- Western Ontario Rotator Cuff Index
Time frame: 3-months
Quality of life
Short- Western Ontario Rotator Cuff Index
Time frame: 6-months
Quality of life
Short- Western Ontario Rotator Cuff Index
Time frame: 12-months
Quality of life
5 secondary outcomes
Single Assessment Numeric Evaluation
Time frame: 3-, 6- and 12-months
Number of days lost
Time frame: 3-, 6- and 12-months
Therapy Adherence Assessment Tool
Time frame: 3-, 6- and 12-months
Global Rating of Change Scale
Time frame: 6- and 12-months
Adverse Effects
Time frame: 3-, 6- and 12-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Individual participant dataSharing planned: No
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Effects of Different Kinesio Taping Methods in Subacromial Impingement Syndrome
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Nociplastic Pain in Patients Diagnosed With Subacromial Pain Syndrome (SAPS)
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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.
Joy C MacDermid, PhD study chair
Western University, jmacderm@uwo.ca, 519 661 2111 x (88912)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program plus Education and Educational Program (EP). in people with Shoulder Pain, run by Western University, Canada 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 4 inclusion and 1 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 14 May 2018. 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. 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?
Contact Goris Nazari, PhD(C) (519 661 2111 ext. 88912, gnazari@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Firefighter Work Limitation Questionnaire (time frame: 3-months). The study lists 6 primary outcomes in all. 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 14 May 2018.