Manual and Manipulative Therapy for Low Back Pain
Primary Purpose
Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manual / Manipulative Therapy (M/MT)
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, Manual / Manipulative Therapy
Eligibility Criteria
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?"
Sites / Locations
- Center for Integrative Medicine (CIM) at William Beaumont Army Medical Center; Soldier Family Medical Clinic (SFMC) at Ft. Bliss, TXRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
1
2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Decreased pain
Secondary Outcome Measures
Increased function
Full Information
NCT ID
NCT00632060
First Posted
February 29, 2008
Last Updated
March 7, 2008
Sponsor
Samueli Institute for Information Biology
Collaborators
Palmer Center for Chiropractic Research (PCCR), William Beaumont Army Medical Center, United States Army Fort Bliss
1. Study Identification
Unique Protocol Identification Number
NCT00632060
Brief Title
Manual and Manipulative Therapy for Low Back Pain
Official Title
The Efficacy of Manual and Manipulative Therapy for Low Back Pain in Military Active Duty Personnel: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Samueli Institute for Information Biology
Collaborators
Palmer Center for Chiropractic Research (PCCR), William Beaumont Army Medical Center, United States Army Fort Bliss
4. Oversight
5. Study Description
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:
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
Detailed Description
Musculoskeletal injuries are among the highest frequency injuries in military personnel(1). These may result from training exercises, normal job duties, or recreational activities (2). Such injuries may cause reduced levels of performance and therefore decrease military readiness (1). This prospective, randomized, clinical trial compares manual/manipulative therapy (M/MT) and standard care to standard care alone for episodes of low back pain. Patients will be randomized to standard care or standard care plus M/MT. Standard care consists of medication prescribed by the credentialed medical provider; M/MT will be delivered by the chiropractor physician. The trial time period will be 4 weeks with outcome measurements at intake, 2 weeks, and 4 weeks. Outcome measures include the Visual Analogue Scale (VAS) for pain, Roland-Morris Low Back Pain and Disability Questionnaire (RDQ), the Back Pain Functional Scale for assessing function (3), Global Improvement Questionnaire for patient perception regarding improvement in function, Patient Expectation and Patient Satisfaction Questionnaires to examine patient expectations toward care and reception of that care, and drug use and profiles. The SF-36 will be used to measure the general health component and quality of life of our sample (4). This will be a pragmatic study that will allow us the opportunity to develop further investigations leading to a larger scale and more robust clinical trial. In addition, this study will provide information on the challenges and opportunities involved in conducting clinical research concerning M/MT in a military setting and may lead to additional studies at a wider number of bases throughout the US.
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, Manual / Manipulative Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
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.
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Manual / Manipulative Therapy (M/MT)
Other Intervention Name(s)
M/MT
Intervention Description
Subjects will receive M/MT twice a week for 4 weeks
Primary Outcome Measure Information:
Title
Decreased pain
Time Frame
Baseline, 2 weeks, 4 weeks
Secondary Outcome Measure Information:
Title
Increased function
Time Frame
Baseline, 2 weeks, 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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?"
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roxana Delgado, MS
Phone
915-569-3245/3245
Email
roxana.delgado@amedd.army.mil
First Name & Middle Initial & Last Name or Official Title & Degree
CPT Keith P Myers, MD
Phone
915-569-3245
Email
keith.myers@amedd.army.mil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CPT Keith P Myers, MD
Organizational Affiliation
William Beaumont Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Integrative Medicine (CIM) at William Beaumont Army Medical Center; Soldier Family Medical Clinic (SFMC) at Ft. Bliss, TX
City
El Paso
State/Province
Texas
ZIP/Postal Code
79920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roxana Delgado, MS
Phone
915-569-2857
Email
roxana.delgado@amedd.army.mil
First Name & Middle Initial & Last Name & Degree
CPT Keith P Myers, MD
First Name & Middle Initial & Last Name & Degree
LTC Richard Petri, Jr., MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
23060056
Citation
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.
Results Reference
derived
Learn more about this trial
Manual and Manipulative Therapy for Low Back Pain
We'll reach out to this number within 24 hrs