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Clinical Trials/NCT00602901
NCT00602901
Completed
Phase 2

Elderly Back Pain: Comparing Chiropractic to Medical Care

Palmer College of Chiropractic2 sites in 1 country240 target enrollmentJuly 2004

Overview

Phase
Phase 2
Intervention
HVLA-SM
Conditions
Subacute Low Back Pain
Sponsor
Palmer College of Chiropractic
Enrollment
240
Locations
2
Primary Endpoint
Roland Morris Disability Questionnaire(RMDQ).
Status
Completed
Last Updated
9 years ago

Overview

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).

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.

Registry
clinicaltrials.gov
Start Date
July 2004
End Date
March 2007
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Arms & Interventions

HVLA-SM

High-velocity low amplitude spinal manipulation (HVLA-SM)

Intervention: HVLA-SM

LVVA-SM

Low-velocity variable amplitude spinal manipulation (LVVA-SM)

Intervention: LVVA-SM

Usual Medical Care

Usual medical care - (Celebrex, Aleve, Bextra, Naproxen)

Intervention: Usual medical care

Outcomes

Primary Outcomes

Roland Morris Disability Questionnaire(RMDQ).

Time Frame: 6 weeks

Secondary Outcomes

  • Postural Sway(6 weeks)
  • SF-36, v1, Physical Function subscale(6 weeks)
  • Posteroanterior Spinal Stiffness(6 weeks)
  • Sit-to-Stand Maneuver(6 weeks)
  • Spinal Manipulation(6 weeks)
  • Fear Avoidance Beliefs Questionnaire, physical subscale(6 weeks, 3 months, 6 months)
  • Visual Analogue Scale for Pain(6 weeks)

Study Sites (2)

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