Elderly Back Pain: Comparing Chiropractic to Medical Care (HRSA4)

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).

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain; Subacute Low Back Pain
• Intervention / Treatment: Other: HVLA-SM; Other: LVVA-SM; Drug: Usual medical care

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.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Palmer Center for Chiropractic Research
    • Iowa City, Iowa, United States, 52242
      • The University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HVLA-SM; High-velocity low amplitude spinal manipulation (HVLA-SM)	Other: HVLA-SM; High-velocity low amplitude spinal manipulation (HVLA-SM)
Experimental: LVVA-SM; Low-velocity variable amplitude spinal manipulation (LVVA-SM)	Other: LVVA-SM; Low-velocity variable amplitude spinal manipulation (LVVA-SM)
Active Comparator: Usual Medical Care; Usual medical care - (Celebrex, Aleve, Bextra, Naproxen)	Drug: 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.; Other Names: (Celebrex, Aleve, Bextra, Naproxen)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Roland Morris Disability Questionnaire(RMDQ).	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Sit-to-Stand Maneuver	6 weeks
Spinal Manipulation	6 weeks

Collaborators and Investigators

• Sponsor: Palmer College of Chiropractic
• Collaborators: Department of Health and Human Services
• Investigators: Principal Investigator: William C Meeker, DC, M.P.H., Palmer College of Chiropractic; Study Director: Maria A Hondras, DC, MPH, Palmer College of Chiropractic

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: January 15, 2008
• First Submitted That Met QC Criteria: January 25, 2008
• First Posted (Estimate): January 28, 2008

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Naproxen
• Other Study ID Numbers: R18HP01423