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Completed

NCT Number: NCT00602901

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).

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Palmer Center for Chiropractic Research, Davenport, Iowa, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HVLA-SM

Other

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

LVVA-SM

Other

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

Usual medical care

Drug

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 names: (Celebrex, Aleve, Bextra, Naproxen)

Primary outcomes

  1. Roland Morris Disability Questionnaire(RMDQ).

    Time frame: 6 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Palmer College of Chiropractic

Other

Collaborators

  • Department of Health and Human Services

Registry information

Acronym: HRSA4

Important dates

Study start
2004
Primary completion
2006
Study completion
2007
First posted
Jan 28, 2008
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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