- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01692275
Assessment of Chiropractic Treatment for Low Back Pain and Smoking Cessation in Military Active Duty Personnel.
Assessment of Chiropractic Treatment for Low Back Pain and Smoking Cessation in Military Active Duty Personnel
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 92134-5000
- Naval Medical Center San Diego
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Florida
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Pensacola, Florida, United States, 32508-5141
- Naval Hospital Pensacola
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Maryland
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Bethesda, Maryland, United States, 20889-5600
- Walter Reed National Military Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18-50 (Inclusive)
- Diagnosis of acute, subacute or chronic low back pain
- Ability to provide voluntary written informed consent
- Active duty at one of the three participating military sites
Exclusion Criteria:
- LBP from other than somatic tissues as determined by history, examination and course (i.e., pain referred from visceral conditions)
- Co-morbid pathology or poor health conditions that may directly impact spinal pain
- Volunteers who have case histories and physical examination findings indicating other than average good health
- Bone and joint pathology contraindicating CMT (Chiropractic Manipulative Therapy)
- Volunteers with recent spinal fracture (within the last 8 weeks), recent spinal surgery (within the last 12 weeks), concurrent spinal or paraspinal tumor(s), spinal or paraspinal infection(s), inflammatory arthropathies and significant/severe osteoporosis will be referred for appropriate care
- Other contraindications for CMT of the lumbar spine and pelvis (i.e., unstable spinal segments, cauda equine syndrome)
- Pregnant or planning to become pregnant within 3 months
- Altered mental capacity as determined by the clinician
- Unable to speak English
- Use of manipulative care for any reason within the past month
- Unwilling to provide phone and electronic contact information
- Unable to confirm that they will not be transferred during the active phase of the study, i.e., deployment, receive orders for a distant duty assignment or training site or otherwise be absent from the current military site over the next 8 weeks (active study participation period).
- Does not agree to be enrolled regardless of group assignment
- PTSD Classification
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: Medical Care + Chiropractic Care
Medical care plus chiropractic manipulative therapy
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Patients will receive chiropractic spinal manipulative therapy plus conventional medical care.
Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.
Other Names:
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ACTIVE_COMPARATOR: Conventional Medical Care Only
Conventional medical care only
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Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical Rating Scale (NRS) for Prior Week
Time Frame: Baseline, week 6, week 12
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Volunteers will be asked to rate their average level of low back pain (LBP) during the prior week on an ordinal 11-box scale (0=no LBP; 10=worst LBP possible) at baseline and at all of the follow-up assessments.
The NRS has excellent metric properties, is easy to administer and score, and has received much use in LBP research.
Pain data will be collected at baseline and at all endpoint visits.
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Baseline, week 6, week 12
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Roland Morris Disability Questionnaire (RMDQ)
Time Frame: Baseline, week 6, week 12
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We will use a volunteer self-report modified 24-item version of the RMDQ to assess LBP-related disability.
The RMDQ may be the most common and respected LBP assessment instrument in LBP outcomes research.
It is a one page questionnaire related to LBP disability with documented reliability and validity.
It can discriminate between different forms of treatment for back pain, and it is sensitive to clinical change.
The RMDQ has been chosen for a number of clinical trials of LBP treatments for its excellent metric properties, ease of use, patient acceptance, and high face validity.
This questionnaire will be administered at baseline and at all endpoints.
Higher score indicates higher disability.
Scale: 0 (no disability) to 24 (maximum disability).
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Baseline, week 6, week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bothersomeness of Symptoms
Time Frame: Baseline, week 6, week 12
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The bothersomeness of symptoms commonly associated with LBP will be measured using an existing measure from the LBP literature. Bothersomeness questions are practical and have demonstrated good internal consistency, construct validity, and responsiveness to change with time in patients with LBP and sciatica. Possible score ranges from 1 (not at all bothersome) to 5 (extremely bothersome). |
Baseline, week 6, week 12
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Numerical Pain Rating Scale (NRS) for Past 24 Hours
Time Frame: Baseline, week 6, week 12
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Volunteers will be asked to rate their level of pain on that day on an ordinal 11-box scale (0=no LBP; 10=worst LBP possible) at baseline and at all of the follow-up assessments.
The NRS has excellent metric properties, is easy to administer and score, and has received much use in LBP research.
Pain data will be collected at baseline and at all endpoint visits.
The question will capture information pertaining to pain over the last 24 hours.
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Baseline, week 6, week 12
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Healthcare Utilization & Medication Use
Time Frame: week 6, week 12
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Based on the pilot study, volunteers will most likely have been seen by other healthcare providers and prescribed pain medication by a primary care provider prior to being enrolled in the study, this questionnaire will ensure that we collect all healthcare and medication use.
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week 6, week 12
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Global Improvement Scale
Time Frame: Week 6
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This is a modification of the visual analog scale (VAS) developed to assess degree of improvement over a specified period of time.
Global low back pain (LBP) improvement was assessed by asking participants to rate their perceived LBP improvement since baseline on a 7-point scale: 0 = completely gone, 1 = much better, 2 = moderately better, 3 = a little better, 4 = about the same, 5 = a little worse, 6 = much worse.
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Week 6
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Patient Satisfaction
Time Frame: Week 6
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A one item patient satisfaction questionnaire.
Satisfaction is measured as means on a numerical rating scale, 0 [not at all satisfied] to 10 [extremely satisfied].
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Week 6
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Patient Expectation
Time Frame: Baseline only
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Previous work has shown that patient expectation regarding benefit of care can be a significant non-specific effect. The score indicates participant's expectation of helpfulness of treatment for LBP, measured on a scale of 0 (not helpful at all) to 10 (extremely helpful). |
Baseline only
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Back Pain Functional Scale (BPFS)
Time Frame: Baseline and all endpoint visits (week 2, week 4, week 6, week 12)
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The BPFS is a 12-question functional status survey designed for use as an individual patient decision-making tool.
Each of the 12 questions is answered using a 5-point Likert-type scale and therefore scores for this scale will range from 0-60 (higher scores indicate better function).
In recent studies, the BPFS is improved sensitivity to change than the RMDQ.
This scale will be administered at baseline and all endpoint visits.
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Baseline and all endpoint visits (week 2, week 4, week 6, week 12)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ian D. Coulter, Ph.D., RAND
Publications and helpful links
General Publications
- Goertz CM, Long CR, Vining RD, Pohlman KA, Kane B, Corber L, Walter J, Coulter I. Assessment of chiropractic treatment for active duty, U.S. military personnel with low back pain: study protocol for a randomized controlled trial. Trials. 2016 Feb 9;17:70. doi: 10.1186/s13063-016-1193-8.
- Goertz CM, Long CR, Vining RD, Pohlman KA, Walter J, Coulter I. Effect of Usual Medical Care Plus Chiropractic Care vs Usual Medical Care Alone on Pain and Disability Among US Service Members With Low Back Pain: A Comparative Effectiveness Clinical Trial. JAMA Netw Open. 2018 May 18;1(1):e180105. doi: 10.1001/jamanetworkopen.2018.0105.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-0782
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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