Assessment of Chiropractic Treatment for Low Back Pain and Smoking Cessation in Military Active Duty Personnel.
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|ClinicalTrials.gov Identifier: NCT01692275|
Recruitment Status : Completed
First Posted : September 25, 2012
Results First Posted : December 19, 2018
Last Update Posted : December 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lower Back Pain||Other: Medical Care + Chiropractic Care Other: Conventional Medical Care Only||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||750 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Assessment of Chiropractic Treatment for Low Back Pain and Smoking Cessation in Military Active Duty Personnel|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||November 28, 2016|
|Actual Study Completion Date :||November 28, 2016|
Active Comparator: Medical Care + Chiropractic Care
Medical care plus chiropractic manipulative therapy
Other: Medical Care + Chiropractic Care
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.
Active Comparator: Conventional Medical Care Only
Conventional medical care only
Other: Conventional Medical Care Only
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.
- Numerical Rating Scale (NRS) for Prior Week [ Time Frame: Baseline, week 6, week 12 ]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.
- Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: Baseline, week 6, week 12 ]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).
- Bothersomeness of Symptoms [ Time Frame: Baseline, week 6, week 12 ]
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).
- Numerical Pain Rating Scale (NRS) for Past 24 Hours [ Time Frame: Baseline, week 6, week 12 ]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.
- Healthcare Utilization & Medication Use [ Time Frame: week 6, week 12 ]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.
- Global Improvement Scale [ Time Frame: Week 6 ]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.
- Patient Satisfaction [ Time Frame: Week 6 ]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].
- Patient Expectation [ Time Frame: Baseline only ]
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).
- Back Pain Functional Scale (BPFS) [ Time Frame: Baseline and all endpoint visits (week 2, week 4, week 6, week 12) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692275
|United States, California|
|Naval Medical Center San Diego|
|San Diego, California, United States, 92134-5000|
|United States, Florida|
|Naval Hospital Pensacola|
|Pensacola, Florida, United States, 32508-5141|
|United States, Maryland|
|Walter Reed National Military Medical Center|
|Bethesda, Maryland, United States, 20889-5600|
|Principal Investigator:||Ian D. Coulter, Ph.D.||RAND|