- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00632060
Manual and Manipulative Therapy for Low Back Pain
The Efficacy of Manual and Manipulative Therapy for Low Back Pain in Military Active Duty Personnel: A Feasibility Study
The specific aims of this research project are to determine feasibility of, and the comparative treatment effect size for, conducting a larger clinical trial of Manual/Manipulative Therapy (M/MT) in restoring peak performance in military personnel in operational environments and to evaluate the ability of the addition of M/MT to standard care to decrease pain and increase function for patients with low back pain.
The following two hypotheses will guide the data collection:
- The primary hypothesis is that the addition of acourse of M/MT to standard care for low back pain will decrease pain at 4 weeks when compared to standard care alone
- In addition, the secondary hypothesis will be that the addition of a course of M/MT to standard care for low back pain will decrease pain and increase function over 2 and 4 weeks when compared to standard care alone
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Roxana Delgado, MS
- Phone Number: 915-569-3245/3245
- Email: roxana.delgado@amedd.army.mil
Study Contact Backup
- Name: CPT Keith P Myers, MD
- Phone Number: 915-569-3245
- Email: keith.myers@amedd.army.mil
Study Locations
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Texas
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El Paso, Texas, United States, 79920
- Recruiting
- Center for Integrative Medicine (CIM) at William Beaumont Army Medical Center; Soldier Family Medical Clinic (SFMC) at Ft. Bliss, TX
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Contact:
- Roxana Delgado, MS
- Phone Number: 915-569-2857
- Email: roxana.delgado@amedd.army.mil
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Principal Investigator:
- CPT Keith P Myers, MD
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Sub-Investigator:
- LTC Richard Petri, Jr., MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Active Duty
- Aged 18-35
- New episode of low back pain (LBP) or a reoccurence of a past episode of low back pain
Exclusion Criteria:
- LBP from other somatic tissues as determined by history, examination, and course (i.e. pain referred from visceral conditions)
- Radicular pain worse than back pain
- Co-morbid pathology or poor health conditions that may directly impact spinal pain. Patients who have case histories and physical examination findings indicating other than average health will be excluded from the study
- Bone and joint pathology contraindicating patient for M/MT. Patients with spinal fracture, tumors, infections, inflammatory arthropathies and significant osteoporosis will be referred for appropriate care and will be excluded from the study
- Other contraindications for M/MT of the lumbar spine and pelvis (i.e. bleeding disorders or anticoagulant therapy)
- Pregnancy (all potential female participants will undergo pregnancy testing)
- Use of manipulative care for any reason within the past month
- Unable to follow course of care for four weeks
- Unable to give informed consent for any reason
- Unable to confirm that they will not be deployed during the course of the study: "Will you be deployed, receiving orders for a distant temporary active duty assignment, attending training at a distant sight, or otherwise absent from Ft. Bliss over the next 6 weeks?"
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: 1
Standard Care Control Group - Participants randomized to the standard care group will continue their use of non-prescription or prescription medication and reduced duty loads, as prescribed by the credentialed medical provider.
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|
EXPERIMENTAL: 2
Manual / Manipulative Therapy Group: Participants randomized to the M/MT group will receive a course of M/MT along with standard care.
The patient will see the chiropractor twice a week for the entire course of the study, regardless of manipulation or not.
|
Subjects will receive M/MT twice a week for 4 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Decreased pain
Time Frame: Baseline, 2 weeks, 4 weeks
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Baseline, 2 weeks, 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Increased function
Time Frame: Baseline, 2 weeks, 4 weeks
|
Baseline, 2 weeks, 4 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: CPT Keith P Myers, MD, William Beaumont Army Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1 EA-0000055
- WBAMC #06/05; USUHS TX781-AX-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
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Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
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Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
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University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
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Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
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University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
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Ache Laboratorios Farmaceuticos S.A.Unknown
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Palmer College of ChiropracticDepartment of Health and Human ServicesCompletedChronic Low Back Pain | Subacute Low Back PainUnited States
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Universität Duisburg-EssenSiemens-BetriebskrankenkasseCompletedChronic Low Back Pain | Recurrent Low Back Pain
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Karolinska InstitutetCompletedChronic Low Back Pain | Recurrent Low Back Pain | Persistent Low Back PainSweden
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Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
Clinical Trials on Manual / Manipulative Therapy (M/MT)
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Cleveland Chiropractic CollegeDurban University of Technology; Macquarie University, AustraliaUnknownOsteoarthritis, HipUnited States, Australia, South Africa
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingFibrosis | Dysphagia | Cancer Survivor | Head and Neck CarcinomaUnited States
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Gerencia Atencion Primaria Area 3University of AlcalaCompleted
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Studio Osteopatico Busto ArsizioRecruitingGastro-oesophageal Reflux DiseaseItaly
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Universidade Federal de Sao CarlosNot yet recruitingChronic Low-back PainBrazil
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Canandaigua VA Medical CenterCompletedChronic Lower Back PainUnited States
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Madigan Army Medical CenterUniversity of Puget Sound; Franklin Pierce UniversityCompletedShoulder Impingement SyndromeUnited States
-
Federal University of Rio Grande do SulCompletedTemporomandibular Disorder
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University of FloridaCompletedLow Back PainUnited States
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Santa Catarina Federal UniversityCompleted