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Elderly Back Pain: Comparing Chiropractic to Medical Care

Elderly Back Pain: Comparing Chiropractic to Medical Care

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00602901
Acronym
HRSA4
Enrollment
240
Registered
2008-01-28
Start date
2004-07-31
Completion date
2007-03-31
Last updated
2017-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subacute Low Back Pain, Chronic Low Back Pain

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.

Interventions

OTHERHVLA-SM

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

OTHERLVVA-SM

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

Celebrex: po, 200mg, qd, six weeks; Aleve: po, 220mg, bid, six weeks; Bextra: po, 10mg, qd, six weeks; Naproxen: po, 500mg, bid, six weeks.

Sponsors

Department of Health and Human Services
CollaboratorFED
Palmer College of Chiropractic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
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 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.

Design outcomes

Primary

MeasureTime frame
Roland Morris Disability Questionnaire(RMDQ).6 weeks

Secondary

MeasureTime frame
Visual Analogue Scale for Pain6 weeks
Postural Sway6 weeks
SF-36, v1, Physical Function subscale6 weeks
Fear Avoidance Beliefs Questionnaire, physical subscale6 weeks, 3 months, 6 months
Sit-to-Stand Maneuver6 weeks
Spinal Manipulation6 weeks
Posteroanterior Spinal Stiffness6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026