Low Back PainPhase 2NCT00394264
How Does Manual Therapy Improve Low Back Pain for Soldiers?
A Phase 2 study testing Soft Tissue, Myofascial release and Counterstrain in people with Low Back Pain, run by University of North Texas Health Science Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 35 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Soft Tissue, Myofascial release and Counterstrain
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Oct 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Madigan Army Medical Center
Fort Lewis, Washington, 98431
Douglas M Maurer, D.O., 253-968-3127, Douglas.Maurer@us.army.mil
Nancy Allison, 253-968-4647, nancy.allison@us.army.mil
About this study
Official title: Manual Manipulative Therapy for Back Pain in Active Duty Military Personnel
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.
Read more
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Soft Tissue, Myofascial release, Counterstrain, Muscle energy, Sacro-iliac articulation
- Keywords
- low back pain, active duty military personnel, manual/manipulative therapy, osteopathic manipulative treatment, physical medicine
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft TissueProcedure or surgery
Myofascial releaseProcedure or surgery
CounterstrainProcedure or surgery
Muscle energyProcedure or surgery
Sacro-iliac articulationProcedure or surgery
High-velocity, low amplitudeProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Functionality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2006 (estimated)
- Study startOct 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Collaborators
- Samueli Institute for Information Biology, Madigan Army Medical Center
- Investigators
- Scott T Stoll, D.O., Ph.D., Principal investigator, Osteopathic Research Center University of North Texas Health Science CenterDouglas M Maurer, D.O., Principal investigator, U.S. Army-Madigan Army Medical Center, Fort Lewis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394264
- Sponsor's protocol ID
- 1 EA-0000048
- Other IDs
- MILCAM-Madigan-Ft. Lewis
- Status last verified
- Oct 2006
- First submitted
- 27 Oct 2006
- Last updated
- 31 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Manipulative Therapy for Back Pain in Active Duty Military Personnel
- ClinicalTrials.gov ID
- NCT00394264
- Acronym / sponsor ID
- 1 EA-0000048
- Conditions
- Low Back Pain
- Keywords
- low back pain, active duty military personnel, manual/manipulative therapy, osteopathic manipulative treatment, physical medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Collaborators
- Samueli Institute for Information Biology, Madigan Army Medical Center
- Study start
- Oct 2006
- Study completion
- Oct 2007
- First posted
- 31 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 17 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soft Tissue | Procedure or surgery | – |
| Myofascial release | Procedure or surgery | – |
| Counterstrain | Procedure or surgery | – |
| Muscle energy | Procedure or surgery | – |
| Sacro-iliac articulation | Procedure or surgery | – |
| High-velocity, low amplitude | Procedure or surgery | – |
Primary outcome
Pain
Functionality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2006.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott T Stoll, D.O., Ph.D. principal investigator
Osteopathic Research Center University of North Texas Health Science Center
Douglas M Maurer, D.O. principal investigator
U.S. Army-Madigan Army Medical Center, Fort Lewis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Soft Tissue, Myofascial release and Counterstrain in people with Low Back Pain, run by University of North Texas Health Science Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact des Anges Cruser, Ph.D., MPA (817-735-2009, dcruser@hsc.unt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2006.