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NCT03864224 Clinical Trial

A Pilot Implementation Study of GLA:D Back

Low Back Pain Clinical Trial

Official title:
A Pilot Implementation Study of GLA:D Back

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03864224
Other study ID # PRO00085118
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 11, 2019
Est. completion date June 8, 2022

Study information
Verified date April 2022
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 190
Est. completion date June 8, 2022
Est. primary completion date February 11, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• GLA:D Back
GLA:D Back is a 10-week program based on first-line recommendations of patient education and structured exercise taught in a group format.

Locations
Country Name City State
Canada University of Alberta Edmonton Alberta

Sponsors (1)
Lead Sponsor Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Implementation Number of clinicians who implement the program 6 months
Secondary Patients enrolled Number of patients trained by each GLA:D clinician 6 months
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