How Does Manual Therapy Improve Low Back Pain for Soldiers?
Manual Manipulative Therapy for Back Pain in Active Duty Military Personnel
2 other identifiers
interventional
100
1 country
1
Brief Summary
Musculoskeletal injuries including low back pain (LBP) are a major problem in military personnel. These injuries can result from training exercises, job duties, or recreational activities. However incurred, many of these injuries can result in limited duty in work or training, and can decrease military readiness. The National Osteopathic Research Center (ORC) will examine the effectiveness of a specific set of Osteopathic Manipulative Treatment interventions referred to as Manual/Manipulative Therapy (M/MT) to reduce pain and improve functioning in young active duty military personnel. The broad overall goal of this proposed research project is to determine the feasibility of conducting a larger clinical trial of Manual/Manipulative Therapy (M/MT) in restoring full performance in military personnel in the operational environment. A second goal is to estimate the treatment effect size of M/MT in this population. The following two hypotheses will guide the data study:
- Hypothesis 1: Subjects receiving manual/manipulative therapy for low back pain will report less pain at two and four weeks than subjects in the control group.
- Hypothesis 2: Subjects receiving manual/manipulative therapy for low back pain will achieve greater functioning at two and four weeks than subjects in the control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 low-back-pain
Started Oct 2006
Shorter than P25 for phase_2 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, 2006
CompletedFirst Submitted
Initial submission to the registry
October 27, 2006
CompletedFirst Posted
Study publicly available on registry
October 31, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedOctober 31, 2006
October 1, 2006
October 27, 2006
October 27, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pain
Functionality
Interventions
Eligibility Criteria
You may qualify if:
- Active duty military personnel
- Male and Female
- Age range 17-35
- Present with a new episode of low back pain (may be acute or new episode of chronic)
You may not qualify if:
- Pregnancy
- Any serious neurological, rheumatological, or orthopedic conditions such as spondylolysis, spondylolithesis,fracture, nerve impingement, tumors, or infections.
- Prior manipulative treatment for this episode LBP.
- Leg pain worse than back pain indicating possible radiculopathy.
- Clinical evidence of a leg length discrepancy greater than 13mm.
- Inability to give informed consent.
- Inability to follow course of care for four weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Madigan Army Medical Center
Fort Lewis, Washington, 98431, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott T Stoll, D.O., Ph.D.
Osteopathic Research Center University of North Texas Health Science Center
- PRINCIPAL INVESTIGATOR
Douglas M Maurer, D.O.
U.S. Army-Madigan Army Medical Center, Fort Lewis
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 27, 2006
First Posted
October 31, 2006
Study Start
October 1, 2006
Study Completion
October 1, 2007
Last Updated
October 31, 2006
Record last verified: 2006-10