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Elderly Back Pain: Comparing Chiropractic to Medical Care (HRSA4)

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.
 
ClinicalTrials.gov Identifier: NCT00602901
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : April 6, 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 low back pain (LBP).

Condition or disease Intervention/treatment Phase
Subacute Low Back Pain Chronic Low Back Pain Other: HVLA-SM Other: LVVA-SM Drug: Usual medical care Phase 2

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 pack 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 : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Elderly Back Pain: Comparing Chiropractic to Medical Care
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

Drug Information available for: Naproxen

Arms and Interventions
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Arm Intervention/treatment
Experimental: HVLA-SM
High-velocity low amplitude spinal manipulation (HVLA-SM)
 Other: HVLA-SM
High-velocity low amplitude spinal manipulation (HVLA-SM)
Experimental: LVVA-SM
Low-velocity variable amplitude spinal manipulation (LVVA-SM)
 Other: LVVA-SM
Low-velocity variable amplitude spinal manipulation (LVVA-SM)
Active Comparator: Usual Medical Care
Usual medical care - (Celebrex, Aleve, Bextra, Naproxen)
 Drug: Usual medical care
Celebrex: po, 200mg, qd, six weeks; Aleve: po, 220mg, bid, six weeks; Bextra: po, 10mg, qd, six weeks; Naproxen: po, 500mg, bid, six weeks.
Other Name: (Celebrex, Aleve, Bextra, Naproxen)


Outcome Measures
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Primary Outcome Measures :
  1. Roland Morris Disability Questionnaire(RMDQ). [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Fear Avoidance Beliefs Questionnaire, physical subscale [ Time Frame: 6 weeks, 3 months, 6 months ]
  2. Visual Analogue Scale for Pain [ Time Frame: 6 weeks ]
  3. Postural Sway [ Time Frame: 6 weeks ]
  4. SF-36, v1, Physical Function subscale [ Time Frame: 6 weeks ]
  5. Posteroanterior Spinal Stiffness [ Time Frame: 6 weeks ]
  6. Sit-to-Stand Maneuver [ Time Frame: 6 weeks ]
  7. Spinal Manipulation [ Time Frame: 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 55 or older
  • Idiopathic low back pain (LBP) of at least four weeks duration
  • Meet the diagnostic classification of 1, 2, or 3 according to the Quebec Task Force on Spinal Disorders

Exclusion Criteria:

  • Low back pain (LBP) not meeting Quebec Task Force Diagnostic Classifications 1, 2 or 3, especially LBP associated with: frank radiculopathy, altered lower extremity reflex, dermatomal sensory deficit, progressive unilateral muscle weakness or motor loss, symptoms of cauda equina compression, and CT or MRI evidence of anatomical pathology (e.g. abnormal disc, lateral or central stenosis.
  • Co-morbid conditions or general poor health that could significantly complicate the prognosis of LBP, including pregnancy, bleeding disorders, extreme obesity, and clear evidence of narcotic or other drug abuse.
  • Major clinical depression defined as scores greater that 29 on the Beck Depression Inventory - Second Edition
  • Bone or joint pathology that contraindicate spinal manipulative therapy of joint pathology that contraindicate spinal manipulative therapy of the arthropathies and significant osteoporosis
  • Pacemaker, because there are safety issues with equipment used to collect data in the biomechanical testing laboratory
  • Current or pending litigation related to current episode of LBP.
  • Receiving disability for any health-related condition
  • Spinal Manipulative care for any reason within the past month
  • Unwilling to postpone use of manual therapies for LBP except those provided in the study for the duration of the study period.
  • Unable to read or verbally comprehend English.
Contacts and Locations
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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): NCT00602901


Locations
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United States, Iowa
Palmer Center for Chiropractic Research
Davenport, Iowa, United States, 52803
The University of Iowa
Iowa City, Iowa, United States, 52242
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 College of Chiropractic
Study Director: Maria A Hondras, DC, MPH Palmer College of Chiropractic
More Information
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Publications of Results:

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Responsible Party: Palmer College of Chiropractic
ClinicalTrials.gov Identifier: NCT00602901    
Other Study ID Numbers: R18HP01423
First Posted: January 28, 2008    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action