- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03864224
A Pilot Implementation Study of GLA:D Back
July 6, 2022 updated by: University of Alberta
GLA:D Back is a program developed in Denmark to help people with persistent low back pain.
This pilot study will assist in contextualizing Danish content into an English version of the program.
Study Overview
Detailed Description
GLA:D Back is a program developed in Denmark to help people with persistent low back pain.
Unfortunately, all materials developed for the program are in Danish.
In this pilot, the investigators will translate the Danish materials into English, then use them to conduct an English training session for community clinicians in Edmonton, Alberta, Canada.
Interested clinicians will then implement the program in their communities and provide feedback to contextualize the program for use in English.
Specifically, surveys, interviews and focus groups will be used to help fine-tune the printed content of the course (e.g.
manuals), it's training materials (e.g.
lectures) and processes related to REDCap data collection (e.g.
surveys).
Study Type
Observational
Enrollment (Actual)
190
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2G4
- University of Alberta
-
-
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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
English speaking adults greater than 18 years of age.
Description
Inclusion Criteria:
- Patients must have persistent low back pain of at least 1 month's duration.
Exclusion Criteria:
- Participating currently in a supervised exercise or rehabilitation program or enrolled in another interventional clinical trial.
- Patients with nerve root involvement, suspected serious pathology, unstable trauma to the spine, aspects of pregnancy or other conditions that would prevent participation or disallow trial completion within the prescribed time period.
- Persons with conditions that require a specialist consult are suspected of needing a specialist consult, or have conditions that would be aggravated or worsened if treated by the interventions in this study.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implementation
Time Frame: 6 months
|
Number of clinicians who implement the program
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients enrolled
Time Frame: 6 months
|
Number of patients trained by each GLA:D clinician
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ACTUAL)
February 11, 2019
Primary Completion (ACTUAL)
February 11, 2020
Study Completion (ACTUAL)
June 8, 2022
Study Registration Dates
First Submitted
March 4, 2019
First Submitted That Met QC Criteria
March 4, 2019
First Posted (ACTUAL)
March 6, 2019
Study Record Updates
Last Update Posted (ACTUAL)
July 8, 2022
Last Update Submitted That Met QC Criteria
July 6, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO00085118
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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-
Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
Clinical Trials on GLA:D Back
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University of AlbertaMcCaig Institute for Bone and Joint HealthCompleted
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Hospital of South West JutlandOdense University HospitalCompletedChronic Pain | Osteoarthritis, KneeDenmark
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Marshall UniversityUniversity of Toronto; University of Southern DenmarkRecruitingOsteoarthritis, KneeUnited States
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University of Colorado, DenverNational Heart, Lung, and Blood Institute (NHLBI)RecruitingAsthma in ChildrenUnited States
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Dallas VA Medical CenterAspen Medical ProductsCompletedLow Back Pain | Degenerative Disc Disease | Lumbar Spondylosis
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Johns Hopkins UniversityRecruitingBack Pain | Low Back PainUnited States
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Soonchunhyang University HospitalCompleted
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Cleveland Clinic FloridaIntegral Orthopedics Inc.CompletedLow Back PainUnited States