How Does Manual Therapy Improve Low Back Pain for Soldiers?
Primary Purpose
Low Back Pain
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Soft Tissue
Myofascial release
Counterstrain
Muscle energy
Sacro-iliac articulation
High-velocity, low amplitude
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, active duty military personnel, manual/manipulative therapy, osteopathic manipulative treatment, physical medicine
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Sites / Locations
- Madigan Army Medical CenterRecruiting
Outcomes
Primary Outcome Measures
Pain
Functionality
Secondary Outcome Measures
Full Information
NCT ID
NCT00394264
First Posted
October 27, 2006
Last Updated
October 27, 2006
Sponsor
University of North Texas Health Science Center
Collaborators
Samueli Institute for Information Biology, Madigan Army Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00394264
Brief Title
How Does Manual Therapy Improve Low Back Pain for Soldiers?
Official Title
Manual Manipulative Therapy for Back Pain in Active Duty Military Personnel
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Unknown status
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of North Texas Health Science Center
Collaborators
Samueli Institute for Information Biology, Madigan Army Medical Center
4. Oversight
5. Study Description
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.
Detailed Description
Musculoskeletal injuries are among the most common injuries in the military, and cause more soldiers to miss time from active duty than any other health condition.These injuries account for up to 20% of all clinic visits at Fort Sam Houston.Of these visits, up to 36% are back-related, resulting in lost duty time, lost training time, and a negative impact on military preparedness. It is of interest to the military to refine interventions that would effectively and efficiently treat back related injuries.
Osteopathic manipulative treatment (OMT) has been studied as a treatment for low back pain in both chronic and subacute presentations in a variety of situations. OMT has been found effective in decreasing medication use for back pain and improving pain and functioning.In a study on low back pain in the Navy, use of OMT significantly reduced time on light duty and sick-in-quarters time.
The National Osteopathic Research Center (ORC) proposes to examine the efficacy of a specific set of OMT interventions referred to in this proposal as Manual/Manipulative Therapy (M/MT) to reduce pain and improve functioning in young active duty military personnel.
The site for this study is the Madiagan Amry Medical Center at Fort Lewis, WA. We will sample the active duty personnel who present at the outpatient clinics at the Hospital with a complaint of low back pain. Osteopathic physicians will provide the M/MT.
Enough subjects will be enrolled and randomized in the study for a total of 100 to complete the trial in two groups: a treatment group receiving M/MT plus standard care (SC), and a control group receiving SC only. Standard care may include medications, back care education and exercise instructions, and/or limited duty. M/MT sessions will last approximately 15-20 minutes, and will be provided up to twice a week for up to four weeks. Standard care will be provided as needed.
Outcomes to be measured are pain and functionality. Pain measures include a Visual Analog Scale (VAS) and medication use. Function will be measured by the Back Pain Functional Scale (BPFS), Roland-Morris Questionnaire (RMQ), and time on modified duty. The VAS and duty status will be recorded at each visit. All other outcomes will be assessed at two and four weeks.
At the initial visit, we will also collect demographic data, medical history, information on quality of life using the SF-36, and subject treatment expectation. A subject satisfaction survey and a measure of overall improvement will be completed at two and four weeks.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, active duty military personnel, manual/manipulative therapy, osteopathic manipulative treatment, physical medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Soft Tissue
Intervention Type
Procedure
Intervention Name(s)
Myofascial release
Intervention Type
Procedure
Intervention Name(s)
Counterstrain
Intervention Type
Procedure
Intervention Name(s)
Muscle energy
Intervention Type
Procedure
Intervention Name(s)
Sacro-iliac articulation
Intervention Type
Procedure
Intervention Name(s)
High-velocity, low amplitude
Primary Outcome Measure Information:
Title
Pain
Title
Functionality
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
des Anges Cruser, Ph.D., MPA
Phone
817-735-2009
Email
dcruser@hsc.unt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott T Stoll, D.O., Ph.D.
Organizational Affiliation
Osteopathic Research Center University of North Texas Health Science Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Douglas M Maurer, D.O.
Organizational Affiliation
U.S. Army-Madigan Army Medical Center, Fort Lewis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Madigan Army Medical Center
City
Fort Lewis
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglas M Maurer, D.O.
Phone
253-968-3127
Email
Douglas.Maurer@us.army.mil
First Name & Middle Initial & Last Name & Degree
Nancy Allison
Phone
253-968-4647
Email
nancy.allison@us.army.mil
First Name & Middle Initial & Last Name & Degree
Douglas M Maurer, D.O.
12. IPD Sharing Statement
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How Does Manual Therapy Improve Low Back Pain for Soldiers?
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