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Predicting Patients' Response to Spinal Manipulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00285649
First Posted: February 2, 2006
Last Update Posted: August 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Palmer College of Chiropractic
  Purpose
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 Intervention
Low Back Pain Other: HVLA-SM Other: LVVA-SM Other: Usual Medical Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Predicting Patients' Response to Spinal Manipulation

Resource links provided by NLM:


Further study details as provided by Palmer College of Chiropractic:

Primary Outcome Measures:
  • 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.


Enrollment: 192
Study Start Date: July 2004
Study Completion Date: March 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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
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
Principal Investigator: William C Meeker, DC, M.P.H. Palmer Chiropractic College
Principal Investigator: David Wilder, PhD The University of Iowa
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Palmer College of Chiropractic
ClinicalTrials.gov Identifier: NCT00285649     History of Changes
Other Study ID Numbers: U19P3
First Submitted: January 31, 2006
First Posted: February 2, 2006
Results First Submitted: April 18, 2017
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:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms