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Back School for Non-specific Low Back Pain (LBP) in an Urban Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02990585
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Marie-Eve Pepin, Wayne State University

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Back school Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2016
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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.
Other: Back school
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.
Other: Back school



Primary Outcome Measures :
  1. Change in the Modified Oswestry Disability Index [ Time Frame: At 4 weeks, 10 weeks, 4 months, and 7 months ]

Secondary Outcome Measures :
  1. Change in the Fear Avoidance Belief Questionnaire -Physical Activity portion [ Time Frame: At 4 weeks, 10 weeks, 4 months, and 7 months ]
  2. Change in the Numeric pain rating scale [ Time Frame: At 4 weeks, 10 weeks, 4 months, and 7 months ]
  3. Change in the International Physical Activity Questionnaire [ Time Frame: At 4 weeks, 10 weeks, 4 months, and 7 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990585


Locations
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United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
Investigators
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Principal Investigator: Marie Pepin, DPT Wayne State University
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Responsible Party: Marie-Eve Pepin, Assistant Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT02990585    
Other Study ID Numbers: 041016MP4E
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations