Official Title: “Elderly Back Pain: Comparing Chiropractic to Medical Care”

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: October 2006

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.

Intervention(s) in this Clinical Trial

• Other: Spinal manipulation
  • High-velocity low amplitude spinal manipulation (HVLA-SM)
• Other: Spinal manipulation
  • Low-velocity variable amplitude spinal manipulation (LVVA-SM)
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • High-velocity low amplitude spinal manipulation (HVLA-SM)
• Experimental: 2
  • Low-velocity variable amplitude spinal manipulation (LVVA-SM)
• Active Comparator: 3
  • Usual medical care

Primary Measures

• Roland Morris Disability Questionnaire(RMDQ).
  • Time Frame: 6 weeks
    Safety Issue?: No

Secondary Measures

• Fear Avoidance Beliefs Questionnaire, physical subscale
  • Time Frame: 6 weeks, 3 months, 6 months
    Safety Issue?: No
• Visual Analogue Scale for Pain
  • Time Frame: 6 weeks
    Safety Issue?: No
• Postural Sway
  • Time Frame: 6 weeks
    Safety Issue?: No
• SF-36, v1, Physical Function subscale
  • Time Frame: 6 weeks
    Safety Issue?: No
• Posteroanterior Spinal Stiffness
  • Time Frame: 6 weeks
    Safety Issue?: No
• Sit-to-Stand Maneuver
  • Time Frame: 6 weeks
    Safety Issue?: No
• Spinal Manipulation
  • Time Frame: 6 weeks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Palmer College of Chiropractic

Overall Clinical Trial Officials and Contacts

William C Meeker, DC, M.P.H. Principal Investigator Palmer College of Chiropractic  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00602901

Study ID Number: R18HP01423

ClinicalTrials.gov Identifier: NCT00602901

Health Authority: United States: Institutional Review Board