Assessment of Chiropractic Treatment for Low Back Pain and Smoking Cessation in Military Active Duty Personnel. (No)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by RAND
Sponsor:
Collaborators:
Palmer College of Chiropractic
Samueli Institute for Information Biology
Information provided by (Responsible Party):
RAND
ClinicalTrials.gov Identifier:
NCT01692275
First received: September 6, 2012
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to evaluate the effectiveness of chiropractic manipulative therapy for pain management and improved function in active duty service members with low back pain that do not require surgery. The study will also measure the impact of a tobacco cessation program delivered to participants allocated to the chiropractic arm.


Condition Intervention Phase
Lower Back Pain
Other: Medical Care + Chiropractic Care
Other: Conventional Medical Care Only
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by RAND:

Primary Outcome Measures:
  • Numerical Pain Rating Scale (NRS) [ Time Frame: Baseline and all endpoint visits (week 2, week 4, week 6, week 12) ] [ Designated as safety issue: No ]
    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.

  • Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: Baseline and all endpoint visits (week 2, week 4, week 6, week 12) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Back Pain Functional Scale (BPFS) [ Time Frame: Baseline and all endpoint visits (week 2, week 4, week 6, week 12) ] [ Designated as safety issue: No ]
    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. In recent studies, the BPFS is improved sensitivity to change than the RMDQ. This scale will be administered at baseline and all endpoint visits.


Other Outcome Measures:
  • Bothersomeness of Symptoms [ Time Frame: at baseline and at all endpoint visits (week 2, week 4, week 6, week 12) ] [ Designated as safety issue: No ]
    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.

  • Patient Reported Outcomes Measurement Information System (PROMIS-29) [ Time Frame: Baseline, week 6, and week 12 ] [ Designated as safety issue: No ]
    PROMIS was a recently developed scoring system consisting of a battery of assessment tools that measure patient-reported health status.

  • Healthcare Utilization & Medication Use [ Time Frame: Baseline and all endpoint visits (week 2, week 4, week 6, week 12) ] [ Designated as safety issue: No ]
    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.

  • Tobacco Dependence [ Time Frame: Baseline, week 6, and week 12 ] [ Designated as safety issue: No ]
    The level of tobacco dependence will be evaluated as in Fagerstrom & Schneider. We will ask how long the volunteer has smoked, how soon after waking the first cigarette is smoked, and if there are strong cravings when going two hours without a cigarette.

  • Patient Satisfaction [ Time Frame: Week 2, week 4, and week 6 ] [ Designated as safety issue: No ]
    A one item patient satisfaction questionnaire

  • Patient Expectation [ Time Frame: Baseline only ] [ Designated as safety issue: No ]
    Previous work has shown that patient expectation regarding benefit of care can be a significant non-specific effect.

  • Tobacco Use [ Time Frame: Baseline, week 6, and week 12 ] [ Designated as safety issue: No ]
    Volunteers will be asked about their tobacco use with the questionnaire by Gordon et al. The 7-day abstinence will be determined from the point-prevalence of tobacco use. Prolonged abstinence will be defined as no tobacco use in the prior 6 months. Other variables will include annual quit attempts, number of cigarettes smoked per day, extent of current tobacco use, and current readiness to quit.

  • Global Improvement Scale [ Time Frame: Week 6 and week 12 ] [ Designated as safety issue: No ]
    This is a modification of the VAS developed to assess degree of improvement over a specified period of time


Estimated Enrollment: 750
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • spinal manipulative therapy
  • education self management medication heat and ice
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.

Detailed Description:

Low back pain (LBP) is the most common cause of disability worldwide, but it is even more prevalent in active duty military personnel; more than 50% of all diagnoses resulting in disability discharges from the military across all branches are due to musculoskeletal conditions. LBP has been characterized as "The Silent Military Threat" because of its negative impact on mission readiness and the degree to which it compromises a fit fighting force. For these reasons, military personnel with LBP need a practical and effective treatment that relieves their pain and allows them to return to duty quickly, but also one that preserves function and military readiness, addresses the underlying causes of the episode and protects against re‐injury. Currently a clear "gold standard" medical treatment for low back pain does not exist and studies show that evidence‐based guidelines are rarely used in general practice. Thus, there is a need to consider innovative treatment options for chronic diseases such as LBP. Therefore the primary purpose of this study is to assess the effectiveness of chiropractic manipulative therapy (CMT) for pain management and improved function in active duty service members with orthopedic injuries or disorders of the low back that do not require surgery. This multi‐site Phase II Clinical Comparative Effectiveness Trial is designed to rigorously compare the outcomes of CMT and conventional medical care (CMC) to CMC alone. Chiropractic treatment will include CMT plus ancillary physiotherapeutic interventions. CMC will be delivered following current standards of medical practice at each site. At each of the four participating sites, active military personnel, ages 18‐50, who present with acute, sub‐acute or chronic low back pain that does not require surgery will be randomized to one of the two treatment groups. Outcome measures include the Numerical Rating Scale for pain, the Roland‐Morris Low Back Pain and Disability questionnaire, the Back Pain Functional Scale for assessing function, and the Global Improvement questionnaire for patient perception regarding improvement in function. Patient Expectation and Patient Satisfaction questionnaires will be used to examine volunteer expectations toward care and perceptions of that care. Pharmaceutical use and duty status data will also be collected. The PROMIS-29 will be utilized to compare the general health component and quality of life of the sample at baseline. In addition, doctors of chiropractic are well positioned to provide information to support tobacco cessation. Thus this clinical trial will include a nested study designed to measure the impact of a tobacco cessation program delivered by a doctor of chiropractic. The results from this randomized clinical trial, with a nested tobacco cessation intervention, will provide critical information regarding the health and mission‐support benefits of chiropractic health care delivery for active duty service members in the military

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692275

Contacts
Contact: Bridget Kane, MS, CCRC 563-884-5125 bridget.kane@palmer.edu
Contact: Lara Hilton, MPH 310-393-0411 ext 7950 hilton@rand.org

Locations
United States, California
Naval Medical Center San Diego Recruiting
San Diego, California, United States, 92134-5000
Contact: Erin Cesario, BA, CCRC    619-433-5899    erin.cesario@palmer.edu   
Contact: Michael Rosenthal, CAPT    619-532-7140    michael.rosenthal2@med.navy.mil   
Principal Investigator: Michael Rosenthal, CAPT, PT,DSc         
Sub-Investigator: David Ward, DC         
Sub-Investigator: Erin Cesario, BA, CCRC         
United States, Florida
Naval Hospital Pensacola Recruiting
Pensacola, Florida, United States, 32508-5141
Contact: Wendy Freiberger, RN,BSN,CCRC    850-377-9183    wendy.freiberger@palmer.edu   
Contact: Joseph F. Penta, M.D.    850-452-8970 ext 133    joseph.penta@med.navy.mil   
Principal Investigator: Joseph F. Penta, CDR, MD         
Sub-Investigator: Greg Lillie, DC         
Sub-Investigator: Wendy Freiberger, RN, BSN, CCRC         
United States, Maryland
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: Keith P. Myers, MAJ, MD    301-295-7850    keith.p.myers.mil@health.mil   
Contact: Abigail Roots, BA    240-204-2646    abigail.roots@palmer.edu   
Principal Investigator: Keith P. Myers, MAJ, MD         
Sub-Investigator: William Morgan, DC         
Sub-Investigator: Terence Kearney, DC         
Sub-Investigator: Abigail Roots, BA         
Sponsors and Collaborators
RAND
Palmer College of Chiropractic
Samueli Institute for Information Biology
Investigators
Principal Investigator: Ian D. Coulter, Ph.D. RAND Corporation
  More Information

Additional Information:
No publications provided

Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT01692275     History of Changes
Other Study ID Numbers: 2010-0782
Study First Received: September 6, 2012
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014