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Trial record 9 of 1387 for:    Back Pain
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Prevention of Low Back Pain in the Military (POLM)

This study has been completed.
Sponsor:
Collaborator:
Brooke Army Medical Center
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00373009
First received: September 5, 2006
Last updated: December 21, 2011
Last verified: July 2008
History of Changes
  Purpose

We are studying whether specific back exercise and education programs effectively limit the development of chronic low back pain in Soldiers in the United States Army. These programs represent the current best evidence for prevention of low back pain from an exercise and education perspective. This innovative study will investigate whether a combination of evidence-based exercise and education programs effectively decreases the impact of chronic low back pain, when compared to individual evidence-based exercise and education programs, or a traditionally implemented exercise program.


Condition Intervention
Low Back Pain
 Behavioral: Traditional military training
Behavioral: Core stabilization military training
Behavioral: Psychosocial education military training
Behavioral: Combined military training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Low Back Pain in the Military. A Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Episodes of low back pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Duration of low back pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Severity of low back pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Muscle function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Beliefs about low back pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 4325
Study Start Date: February 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Core stabilization and psychosocial education
 Behavioral: Combined military training
Includes both core stabilization training and psychosocial education class
Active Comparator: 2
Core stabilization exercise only
 Behavioral: Core stabilization military training
Core stabilization exercise
Active Comparator: 3
Psychosocial education class only.
 Behavioral: Psychosocial education military training
Psychosocial education class
No Intervention: 4
Traditional Army training
 Behavioral: Traditional military training
As usual training for Soldiers

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 18 - 35 years old (or emancipated minor)
  • Participating in 91 W (combat medic) MOS training
  • English speaking and reading

Exclusion Criteria:

  • Currently seeking medical care for LBP
  • Previous medical history that includes any surgery for LBP (examples include but are not limited to lumbar fusion, lumbar decompression, and lumbar discectomy)
  • History of degenerative joint disease, arthritis, spine trauma or vertebral fractures, spondylolisthesis, and congenital spine disorders
  • Currently unable to participate in AIT due to injury in foot, ankle, knee, hip, neck, shoulder, elbow, wrist, or hand injury.
  • History of fracture (stress or traumatic) in proximal femur and/or pelvis
  • Pregnancy (Note: Pregnancy will not result in termination from the study, even though it is an exclusion criteria at enrollment.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373009

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
University of Florida
Brooke Army Medical Center
Investigators
Principal Investigator: Steven Z George, PT, PHD University of Florida
  More Information

Additional Information:
Link to abstract and paper for primary study results  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00373009     History of Changes
Other Study ID Numbers: PR054098
Study First Received: September 5, 2006
Last Updated: December 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Low back pain
Primary prevention
Secondary prevention
Lumbar stabilization
Psychosocial education

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013