NCT00373009

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,325

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Feb 2007

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

4.2 years

First QC Date

September 5, 2006

Last Update Submit

March 12, 2015

Conditions

Low Back Pain

Keywords

Low back painPrimary preventionSecondary preventionLumbar stabilizationPsychosocial education

Outcome Measures

Primary Outcomes (3)

  • Episodes of low back pain

    2 years

  • Duration of low back pain

    2 years

  • Severity of low back pain

    2 years

Secondary Outcomes (2)

  • Muscle function

    12 weeks

  • Beliefs about low back pain

    12 weeks

Study Arms (4)

Core stabilization and psychosocial education

EXPERIMENTAL

A core stabilization exercise program (CSEP) is used in this group and has sound biomechanical and anatomical rationale. In addition, a psychosocial education program (PSEP) will be used for this group.

Behavioral: Core stabilization and psychosocial education

Core stabilization exercise only

ACTIVE COMPARATOR

A core stabilization exercise program (CSEP) is used in this group and has sound biomechanical and anatomical rationale.

Behavioral: Core stabilization exercise only

Psychosocial education class only.

ACTIVE COMPARATOR

A psychosocial education program (PSEP) will be used in this group.

Behavioral: Psychosocial education class only

Traditional Army training

OTHER

Traditional Army training will be used in this group.

Behavioral: Traditional Army training

Interventions

Traditional Army trainingBEHAVIORAL

As usual training for Soldiers

Traditional Army training
Core stabilization exercise onlyBEHAVIORAL

Core stabilization exercise

Core stabilization exercise only
Psychosocial education class onlyBEHAVIORAL

Psychosocial education class

Psychosocial education class only.
Core stabilization and psychosocial educationBEHAVIORAL

Includes both core stabilization training and psychosocial education class

Core stabilization and psychosocial education

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Florida

Gainesville, Florida, 32610, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (10)

  • George SZ, Childs JD, Teyhen DS, Wu SS, Wright AC, Dugan JL, Robinson ME. Rationale, design, and protocol for the prevention of low back pain in the military (POLM) trial (NCT00373009). BMC Musculoskelet Disord. 2007 Sep 14;8:92. doi: 10.1186/1471-2474-8-92.

    PMID: 17868436BACKGROUND

  • George SZ, Childs JD, Teyhen DS, Wu SS, Wright AC, Dugan JL, Robinson ME. Brief psychosocial education, not core stabilization, reduced incidence of low back pain: results from the Prevention of Low Back Pain in the Military (POLM) cluster randomized trial. BMC Med. 2011 Nov 29;9:128. doi: 10.1186/1741-7015-9-128.

    PMID: 22126534RESULT

  • Childs JD, Teyhen DS, Van Wyngaarden JJ, Dougherty BF, Ladislas BJ, Helton GL, Robinson ME, Wu SS, George SZ. Predictors of web-based follow-up response in the Prevention Of Low Back Pain In The Military Trial (POLM). BMC Musculoskelet Disord. 2011 Jun 13;12:132. doi: 10.1186/1471-2474-12-132.

    PMID: 21668961RESULT

  • Teyhen DS, George SZ, Dugan JL, Williamson J, Neilson BD, Childs JD. Inter-rater reliability of ultrasound imaging of the trunk musculature among novice raters. J Ultrasound Med. 2011 Mar;30(3):347-56. doi: 10.7863/jum.2011.30.3.347.

    PMID: 21357556RESULT

  • Childs JD, Teyhen DS, Casey PR, McCoy-Singh KA, Feldtmann AW, Wright AC, Dugan JL, Wu SS, George SZ. Effects of traditional sit-up training versus core stabilization exercises on short-term musculoskeletal injuries in US Army soldiers: a cluster randomized trial. Phys Ther. 2010 Oct;90(10):1404-12. doi: 10.2522/ptj.20090389. Epub 2010 Jul 22.

    PMID: 20651013RESULT

  • Childs JD, Teyhen DS, Benedict TM, Morris JB, Fortenberry AD, McQueen RM, Preston JB, Wright AC, Dugan JL, George SZ. Effects of sit-up training versus core stabilization exercises on sit-up performance. Med Sci Sports Exerc. 2009 Nov;41(11):2072-83. doi: 10.1249/MSS.0b013e3181a84db2.

    PMID: 19812508RESULT

  • Robinson ME, Teyhen DS, Wu SS, Dugan JL, Wright AC, Childs JD, Yang G, George SZ. Mental health symptoms in combat medic training: a longitudinal examination. Mil Med. 2009 Jun;174(6):572-7. doi: 10.7205/milmed-d-02-4108.

    PMID: 19585767RESULT

  • George SZ, Teyhen DS, Wu SS, Wright AC, Dugan JL, Yang G, Robinson ME, Childs JD. Psychosocial education improves low back pain beliefs: results from a cluster randomized clinical trial (NCT00373009) in a primary prevention setting. Eur Spine J. 2009 Jul;18(7):1050-8. doi: 10.1007/s00586-009-1016-7. Epub 2009 May 6.

    PMID: 19418075RESULT

  • Childs JD, Wu SS, Andrade RL, Bonner VE, Bowman JA, Butler AM, Teyhen DS, George SZ. Incremental Effects of Telephone Call Center and Healthcare Utilization Database Use to Improve Follow-up Rate in the Prevention of Low Back Pain in the Military Trial. US Army Med Dep J. 2015 Oct-Dec:24-30.

    PMID: 26606405DERIVED

  • Childs JD, Wu SS, Teyhen DS, Robinson ME, George SZ. Prevention of low back pain in the military cluster randomized trial: effects of brief psychosocial education on total and low back pain-related health care costs. Spine J. 2014 Apr;14(4):571-83. doi: 10.1016/j.spinee.2013.03.019. Epub 2013 Apr 19.

    PMID: 23608562DERIVED

Related Links

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Steven Z George, PT, PHD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2006

First Posted

September 7, 2006

Study Start

February 1, 2007

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

US(2)