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Elderly Back Pain: Comparing Chiropractic to Medical Care (HRSA4)
This study has been completed.

First Received on January 15, 2008.   Last Updated on August 31, 2009   History of Changes
Sponsor: Palmer College of Chiropractic
Collaborator: Department of Health and Human Services
Information provided by: Palmer College of Chiropractic
ClinicalTrials.gov Identifier: NCT00602901
  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 low back pain (LBP).


Condition Intervention Phase
Subacute Low Back Pain
Chronic Low Back Pain
 Other: Spinal manipulation
Drug: Usual medical care (Celebrex, Aleve, Bextra, Naproxen)
 Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Elderly Back Pain: Comparing Chiropractic to Medical Care

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
Drug Information available for: Naproxen Naproxen sodium Celecoxib Valdecoxib
U.S. FDA Resources

Further study details as provided by Palmer College of Chiropractic:

Primary Outcome Measures:
  • Roland Morris Disability Questionnaire(RMDQ). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fear Avoidance Beliefs Questionnaire, physical subscale [ Time Frame: 6 weeks, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Visual Analogue Scale for Pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Postural Sway [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • SF-36, v1, Physical Function subscale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Posteroanterior Spinal Stiffness [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Sit-to-Stand Maneuver [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Spinal Manipulation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 240
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: 1
High-velocity low amplitude spinal manipulation (HVLA-SM)
 Other: Spinal manipulation
High-velocity low amplitude spinal manipulation (HVLA-SM)
Experimental: 2
Low-velocity variable amplitude spinal manipulation (LVVA-SM)
 Other: Spinal manipulation
Low-velocity variable amplitude spinal manipulation (LVVA-SM)
Active Comparator: 3
Usual medical care
 Drug: Usual medical care (Celebrex, Aleve, Bextra, Naproxen)
Celebrex: po, 200mg, qd, six weeks; Aleve: po, 220mg, bid, six weeks; Bextra: po, 10mg, qd, six weeks; Naproxen: po, 500mg, bid, six weeks.

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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 maniuplative 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602901

Locations
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
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

No publications provided by Palmer College of Chiropractic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Hondras MA, Long CR, Haan AG, Spencer LB, Meeker WC. Recruitment and enrollment for the simultaneous conduct of 2 randomized controlled trials for patients with subacute and chronic low back pain at a CAM research center. J Altern Complement Med. 2008 Oct;14(8):983-92.

Responsible Party: William C. Meeker, Palmer Colleg of Chiropractic - West
ClinicalTrials.gov Identifier: NCT00602901     History of Changes
Other Study ID Numbers: R18HP01423
Study First Received: January 15, 2008
Last Updated: August 31, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Naproxen
Celecoxib
Valdecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on February 13, 2012



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