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Predicting Patients' Response to Spinal Manipulation

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ClinicalTrials.gov Identifier: NCT00285649
Recruitment Status : Completed
First Posted : February 2, 2006
Results First Posted : July 5, 2017
Last Update Posted : August 16, 2017
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Palmer College of Chiropractic

Study Description
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Brief Summary:
The purpose of this study is to compare the clinical effectiveness of two types of chiropractic spinal manipulation to conservative medical care for patients at least 55 years old with sub-acute or chronic LBP.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: HVLA-SM Other: LVVA-SM Other: Usual Medical Care Not Applicable

Detailed Description:
Despite the high prevalence of LBP and the associated economic costs, disability, and lost productivity, and despite the development of several treatment guidelines, one of which recommends chiropractic spinal manipulation for some subgroups of patients with back pain, the management of LBP remains controversial and highly variable across professions and geographic regions. Although one recent publication describes the design of chiropractic and exercise for seniors with low back or neck pain, no published studies, to our knowledge, have assessed the effectiveness of chiropractic manipulation compared to medical care for older adults with sub-acute or chronic low back pain.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Predicting Patients' Response to Spinal Manipulation
Study Start Date : July 2004
Actual Primary Completion Date : October 2006
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: HVLA-SM
HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation
 Other: HVLA-SM
HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation
Experimental: LVVA-SM
LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation
 Other: LVVA-SM
LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation
Active Comparator: Usual Medical Care
Usual Medical Care, Active Comparator, advice, exercises and medications
 Other: Usual Medical Care
Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)


Outcome Measures
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Primary Outcome Measures :
  1. Roland Morris Low Back Pain Disability Questionnaire (RMDQ) [ Time Frame: Mean change from baseline to week 3 ]
    The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. This outcome displays the mean change in RMDQ from baseline to week 3.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 21 to 55
  • Idiopathic mechanical low back pain (LBP) matching classification 1-4 of the Quebec Task Force.
  • LBP classified as subacute (onset 4-12 weeks previous) or chronic (onset more than 12 weeks previous), with the current episode occurring at least four weeks prior to the date of contact with the clinic: In order to exclude the greatest proportion of LBP patients that have a favorable natural history of improvement.
  • Written Informed Consent
  • A minimum baseline score on the Roland Morris Disability Questionnaire (RMQ) of 6 points.

Exclusion Criteria:

  • LBP from other somatic tissues as determined by history, examination, and course (e.g. pain referred from visceral conditions).
  • LBP diagnosis not meeting Classifications 1 through 4 of the Quebec Task Force, especially the following: low back pain associated with frank radiculopathy defined as typical shooting leg pain; positive straight leg-raising test; an altered lower extremity reflex; a dermatomal sensory deficit; at least one of the following: progressive unilateral muscle weakness or motor loss, or symptoms of cauda equina compression; and CT or MRI evidence of related anatomical pathology (e.g. abnormal disc, stenosis).
  • Co-morbid pathology or poor health conditions in patients; Co-morbid conditions and general poor health significantly complicate the prognosis of LBP, and inject a variety of uncontrollable factors in case-management, not to mention experimental analysis and interpretation. Patients who have case histories and physical examination findings indicating other that average good health will be excluded from the study.
  • Bone and joint pathology contraindicating patient for SM of the lumbar spine and pelvis: Patients with spinal fractures, tumors, infections, arthropathies, and significant osteoporosis will be referred to appropriate health care.
  • Other contraindications for SM of the lumbar spine and pelvis (e.g. bleeding disorders or anticoagulant therapy, extreme obesity).
  • Retention of legal advice related to this or a previous LBP episode: Patients with occupational or personal injuries will not be automatically excluded from the study unless they answer yes to a specific question about the retention of legal advice with respect to their LBP episode at the baseline interview.
  • Pregnancy: Pregnancy is a contraindication for exposing a patient to ionizing radiation and is a confounding factor in the usual course of LBP.
  • Inability to read or verbally comprehend English.
  • Clear evidence of narcotic or other drug abuse as determined by history and examination: injects significant confounding factors with respect to internal validity and feasibility.
  • Major clinical depression: Patients with scores greater than 17 on the Beck Depression Inventory will be excluded from the study. Patients with evidence of other psychiatric disorders as determined by history and exam will also be excluded.
  • Use of manipulative care for any reason within the past 3 months as determined by history: to exclude the possibility of carryover effects.
  • Unwillingness to postpone use of all other types of manual treatment for LBP except those provided in the study (including chiropractic and osteopathic SM, physical therapy, and massage) for the duration of the study period: to eliminate confounding effects.
Contacts and Locations
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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): NCT00285649


Locations
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United States, Iowa
Palmer Center for Chiropractic Research
Davenport, Iowa, United States, 52803
Sponsors and Collaborators
Palmer College of Chiropractic
Department of Health and Human Services
Investigators
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Principal Investigator: William C Meeker, DC, M.P.H. Palmer Chiropractic College
Principal Investigator: David Wilder, PhD University of Iowa
More Information
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Additional Information:
Similar Effects of Thrust and Nonthrust Spinal Manipulation Found in Adults With Subacute and Chronic Low Back Pain: A Controlled Trial With Adaptive Allocation.  This link exits the ClinicalTrials.gov site

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Palmer College of Chiropractic
ClinicalTrials.gov Identifier: NCT00285649     History of Changes
Other Study ID Numbers: U19P3
First Posted: February 2, 2006    Key Record Dates
Results First Posted: July 5, 2017
Last Update Posted: August 16, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Palmer College of Chiropractic:
Spinal Manipulation

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms