Back School for Non-specific Low Back Pain (LBP) in an Urban Setting
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
1 other identifier
interventional
11
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable low-back-pain
Started Oct 2016
Typical duration for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 9, 2016
CompletedFirst Posted
Study publicly available on registry
December 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedOctober 3, 2018
October 1, 2018
1.9 years
November 9, 2016
October 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in the Modified Oswestry Disability Index
At 4 weeks, 10 weeks, 4 months, and 7 months
Secondary Outcomes (3)
Change in the Fear Avoidance Belief Questionnaire -Physical Activity portion
At 4 weeks, 10 weeks, 4 months, and 7 months
Change in the Numeric pain rating scale
At 4 weeks, 10 weeks, 4 months, and 7 months
Change in the International Physical Activity Questionnaire
At 4 weeks, 10 weeks, 4 months, and 7 months
Study Arms (2)
One individual back school session
ACTIVE COMPARATORThe 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.
8 group session of back school
ACTIVE COMPARATORAll 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.
Interventions
Eligibility Criteria
You may qualify if:
- Participants 18 years of age or older who have been suffering from non-specific LBP for at least 3 months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wayne State University
Detroit, Michigan, 48201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie Pepin, DPT
Wayne State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 9, 2016
First Posted
December 13, 2016
Study Start
October 1, 2016
Primary Completion
September 1, 2018
Study Completion
September 30, 2018
Last Updated
October 3, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share