Assessment of Chiropractic Treatment for Low Back Pain and Smoking Cessation in Military Active Duty Personnel.

NCT01692275 | Completed Results DMC

• 1 other identifier: 2010-0782
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Lower Back Pain

Outcome Measures

Primary Outcomes (2)

• Numerical Rating Scale (NRS) for Prior Week

  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.

  Baseline, week 6, week 12

• Roland Morris Disability Questionnaire (RMDQ)

  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).

  Baseline, week 6, week 12

Secondary Outcomes (7)

• Bothersomeness of Symptoms

  Baseline, week 6, week 12

• Numerical Pain Rating Scale (NRS) for Past 24 Hours

  Baseline, week 6, week 12

• Healthcare Utilization & Medication Use

  week 6, week 12

• Global Improvement Scale

  Week 6

• Patient Satisfaction

  Week 6

Study Arms (2)

Medical Care + Chiropractic Care

ACTIVE COMPARATOR

Medical care plus chiropractic manipulative therapy

Other: Medical Care + Chiropractic Care

Conventional Medical Care Only

ACTIVE COMPARATOR

Conventional medical care only

Other: Conventional Medical Care Only

Interventions

Medical Care + Chiropractic Care OTHER

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.

Also known as: spinal manipulative therapy, education self management medication heat and ice

Medical Care + Chiropractic Care

Conventional Medical Care Only OTHER

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.

Conventional Medical Care Only

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RAND: lead
• Palmer College of Chiropractic: collaborator
• Samueli Institute for Information Biology: collaborator

Study Sites (3)

Naval Medical Center San Diego

San Diego, California, 92134-5000, United States

Location

Naval Hospital Pensacola

Pensacola, Florida, 32508-5141, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States

Location

Related Publications (3)

• 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.

  PMID: 26857706 BACKGROUND

• 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.

  PMID: 30646047 BACKGROUND

• Shannon ZK, Long CR, Chrischilles E, Goertz C, Wallace R, Casteel C, Carnahan RM. Secondary causal mediation analysis of a pragmatic clinical trial to evaluate the effect of chiropractic care for US active-duty military on biopsychosocial outcomes occurring through effects on low back pain interference and intensity. BMJ Open. 2024 Nov 19;14(11):e083509. doi: 10.1136/bmjopen-2023-083509.

  PMID: 39566948 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Ice

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health

Results Point of Contact

• Title: Dr. Cyndy Long
• Organization: Palmer Center for Chiropractic Research

LONG_C@palmer.edu

563-884-5157

Study Officials

• Ian D. Coulter, Ph.D.

  RAND

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2012
• First Posted: September 25, 2012
• Study Start: September 1, 2012
• Primary Completion: November 28, 2016
• Study Completion: November 28, 2016
• Last Updated: December 19, 2018
• Results First Posted: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)