Elderly Back Pain: Comparing Chiropractic to Medical Care

NCT00602901 | Completed Phase 2

• 1 other identifier: R18HP01423
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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).

Conditions

Subacute Low Back Pain; Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Roland Morris Disability Questionnaire(RMDQ).

  6 weeks

Secondary Outcomes (7)

• Fear Avoidance Beliefs Questionnaire, physical subscale

  6 weeks, 3 months, 6 months

• Visual Analogue Scale for Pain

  6 weeks

• Postural Sway

  6 weeks

• SF-36, v1, Physical Function subscale

  6 weeks

• Posteroanterior Spinal Stiffness

  6 weeks

Study Arms (3)

HVLA-SM

EXPERIMENTAL

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

Other: HVLA-SM

LVVA-SM

EXPERIMENTAL

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

Other: LVVA-SM

Usual Medical Care

ACTIVE COMPARATOR

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

Drug: Usual medical care

Interventions

HVLA-SM OTHER

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

HVLA-SM

LVVA-SM OTHER

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

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.

Also known as: (Celebrex, Aleve, Bextra, Naproxen)

Usual Medical Care

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Palmer College of Chiropractic: lead
• Department of Health and Human Services: collaborator

Study Sites (2)

Palmer Center for Chiropractic Research

Davenport, Iowa, 52803, United States

Location

The University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

• 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.

  PMID: 19539115 RESULT

• 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.

  PMID: 18990046 RESULT

MeSH Terms

Interventions

Celecoxib; Naproxen; valdecoxib

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• William C Meeker, DC, M.P.H.

  Palmer College of Chiropractic

  PRINCIPAL INVESTIGATOR

• Maria A Hondras, DC, MPH

  Palmer College of Chiropractic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2008
• First Posted: January 28, 2008
• Study Start: July 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: March 1, 2007
• Last Updated: April 6, 2017

Record last verified: 2017-04

Locations

US (2)