Elderly Back Pain: Comparing Chiropractic to Medical Care

NCT ID: NCT00602901

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2007-03-31

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.

Conditions

Subacute Low Back Pain; Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HVLA-SM

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

Group Type: EXPERIMENTAL

HVLA-SM

Intervention Type: OTHER

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

LVVA-SM

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

Group Type: EXPERIMENTAL

LVVA-SM

Intervention Type: OTHER

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

Usual Medical Care

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

Group Type: ACTIVE_COMPARATOR

Usual medical care

Intervention Type: 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.

Interventions

HVLA-SM

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

Intervention Type: OTHER

LVVA-SM

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

Intervention Type: OTHER

Usual medical care

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

Intervention Type: DRUG

Other Intervention Names

(Celebrex, Aleve, Bextra, Naproxen)

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of Health and Human Services

FED

Sponsor Role: collaborator

Palmer College of Chiropractic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William C Meeker, DC, M.P.H.

Role: PRINCIPAL_INVESTIGATOR

Palmer College of Chiropractic

Maria A Hondras, DC, MPH

Role: STUDY_DIRECTOR

Palmer College of Chiropractic

Locations

Palmer Center for Chiropractic Research

Davenport, Iowa, United States

The University of Iowa

Iowa City, Iowa, United States

Countries

United States

References

Hondras MA, Long CR, Cao Y, Rowell RM, Meeker WC. A randomized controlled trial comparing 2 types of spinal manipulation and minimal conservative medical care for adults 55 years and older with subacute or chronic low back pain. J Manipulative Physiol Ther. 2009 Jun;32(5):330-43. doi: 10.1016/j.jmpt.2009.04.012.

Reference Type: RESULT

PMID: 19539115 (View on PubMed)

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. doi: 10.1089/acm.2008.0066.

Reference Type: RESULT

PMID: 18990046 (View on PubMed)

Other Identifiers

R18HP01423

Identifier Type: -

Identifier Source: org_study_id