- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02990585
Back School for Non-specific Low Back Pain (LBP) in an Urban Setting
October 1, 2018 updated by: Marie-Eve Pepin, Wayne State University
The Effect of an 8-session Back School Versus a Single, Abbreviated Session When Looking at Non-specific Low Back Pain in an Urban Setting
This study will be a comparative design between 2 groups of subjects attending classes on back education in an urban setting.
Participants will be randomized to either an individual one-on-one back school session or to the 8 group sessions.
Study Overview
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
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
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Michigan
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Detroit, Michigan, United States, 48201
- Wayne State University
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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
Description
Inclusion Criteria:
- Participants 18 years of age or older who have been suffering from non-specific LBP for at least 3 months
Exclusion Criteria:
- Additional impairments contraindicating their safe participation in the back school program, such as evidence of spinal cord pathology, cauda equina, progressive neurological damage, infection, inflammation, malignancy, fracture or a progressive, neurodegenerative disease as well as back surgery within the past year
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: One individual back school session
The 1 individual session will consist of a 60 min 1-on-1 education/exercise session with an athletic trainer.
Information will be an abbreviated version of the 8-session school and fill focus on the strengthening, stretching, pain control and movement re-education most needed for the individual.
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Active Comparator: 8 group session of back school
All sessions last 45-60 minutes.
There will be up to 8 participants in each session which will be led by an athletic trainer or rehabilitation trainer.
Pain management, prevention strategies, and active treatment will be covered in the 8 sessions.
Active treatment includes strengthening, stretching, pain control, movement re-education, and walking.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the Modified Oswestry Disability Index
Time Frame: At 4 weeks, 10 weeks, 4 months, and 7 months
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At 4 weeks, 10 weeks, 4 months, and 7 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the Fear Avoidance Belief Questionnaire -Physical Activity portion
Time Frame: At 4 weeks, 10 weeks, 4 months, and 7 months
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At 4 weeks, 10 weeks, 4 months, and 7 months
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Change in the Numeric pain rating scale
Time Frame: At 4 weeks, 10 weeks, 4 months, and 7 months
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At 4 weeks, 10 weeks, 4 months, and 7 months
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Change in the International Physical Activity Questionnaire
Time Frame: At 4 weeks, 10 weeks, 4 months, and 7 months
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At 4 weeks, 10 weeks, 4 months, and 7 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marie Pepin, DPT, Wayne State University
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
October 1, 2016
Primary Completion (Actual)
September 1, 2018
Study Completion (Actual)
September 30, 2018
Study Registration Dates
First Submitted
November 9, 2016
First Submitted That Met QC Criteria
December 8, 2016
First Posted (Estimate)
December 13, 2016
Study Record Updates
Last Update Posted (Actual)
October 3, 2018
Last Update Submitted That Met QC Criteria
October 1, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 041016MP4E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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