Back to resultsBack School for Non-specific Low Back Pain (LBP) in an Urban Setting
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Back school
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
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
Sites / Locations
- Wayne State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
One individual back school session
8 group session of back school
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in the Modified Oswestry Disability Index
Secondary Outcome Measures
Change in the Fear Avoidance Belief Questionnaire -Physical Activity portion
Change in the Numeric pain rating scale
Change in the International Physical Activity Questionnaire
Full Information
NCT ID
NCT02990585
First Posted
November 9, 2016
Last Updated
October 1, 2018
Sponsor
Wayne State University
1. Study Identification
Unique Protocol Identification Number
NCT02990585
Brief Title
Back School for Non-specific Low Back Pain (LBP) in an Urban Setting
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
One individual back school session
Arm Type
Active Comparator
Arm Description
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.
Arm Title
8 group session of back school
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Back school
Primary Outcome Measure Information:
Title
Change in the Modified Oswestry Disability Index
Time Frame
At 4 weeks, 10 weeks, 4 months, and 7 months
Secondary Outcome Measure Information:
Title
Change in the Fear Avoidance Belief Questionnaire -Physical Activity portion
Time Frame
At 4 weeks, 10 weeks, 4 months, and 7 months
Title
Change in the Numeric pain rating scale
Time Frame
At 4 weeks, 10 weeks, 4 months, and 7 months
Title
Change in the International Physical Activity Questionnaire
Time Frame
At 4 weeks, 10 weeks, 4 months, and 7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Pepin, DPT
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Back School for Non-specific Low Back Pain (LBP) in an Urban Setting
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