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
2 other identifiers
interventional
100
1 country
1
Brief Summary
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:
- 1.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
- 2.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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable low-back-pain
Started Feb 2008
Typical duration for not_applicable low-back-pain
1 active site
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
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 29, 2008
CompletedFirst Posted
Study publicly available on registry
March 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedMarch 10, 2008
February 1, 2008
1.4 years
February 29, 2008
March 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Decreased pain
Baseline, 2 weeks, 4 weeks
Secondary Outcomes (1)
Increased function
Baseline, 2 weeks, 4 weeks
Study Arms (2)
1
NO INTERVENTIONStandard 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.
2
EXPERIMENTALManual / 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.
Interventions
Subjects will receive M/MT twice a week for 4 weeks
Eligibility Criteria
You may qualify if:
- Active Duty
- Aged 18-35
- New episode of low back pain (LBP) or a reoccurence of a past episode of low back pain
You may not qualify if:
- 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?"
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samueli Institute for Information Biologylead
- Palmer Center for Chiropractic Research (PCCR)collaborator
- William Beaumont Army Medical Centercollaborator
- United States Army Fort Blisscollaborator
Study Sites (1)
Center for Integrative Medicine (CIM) at William Beaumont Army Medical Center; Soldier Family Medical Clinic (SFMC) at Ft. Bliss, TX
El Paso, Texas, 79920, United States
Related Publications (1)
Goertz CM, Long CR, Hondras MA, Petri R, Delgado R, Lawrence DJ, Owens EF, Meeker WC. Adding chiropractic manipulative therapy to standard medical care for patients with acute low back pain: results of a pragmatic randomized comparative effectiveness study. Spine (Phila Pa 1976). 2013 Apr 15;38(8):627-34. doi: 10.1097/BRS.0b013e31827733e7.
PMID: 23060056DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
CPT Keith P Myers, MD
William Beaumont Army Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 29, 2008
First Posted
March 10, 2008
Study Start
February 1, 2008
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
March 10, 2008
Record last verified: 2008-02