Elderly Back Pain: Comparing Chiropractic to Medical Care

Chronic Low Back Pain Clinical Trial

— HRSA4  

Official title:

Elderly Back Pain: Comparing Chiropractic to Medical Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00602901
• Other study ID #: R18HP01423
• Status: Completed
• Phase: Phase 2
• First received: January 15, 2008
• Last updated: April 5, 2017
• Start date: July 2004
• Est. completion date: March 2007

Study information

• Verified date: April 2017
• Source: Palmer College of Chiropractic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain
• Subacute Low Back Pain

Intervention

Other:
• HVLA-SM
High-velocity low amplitude spinal manipulation (HVLA-SM)
• LVVA-SM
Low-velocity variable amplitude spinal manipulation (LVVA-SM)

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.

Locations

Country	Name	City	State
United States	Palmer Center for Chiropractic Research	Davenport	Iowa
United States	The University of Iowa	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Palmer College of Chiropractic	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

References & 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 The — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Roland Morris Disability Questionnaire(RMDQ).		6 weeks
Secondary	Fear Avoidance Beliefs Questionnaire, physical subscale		6 weeks, 3 months, 6 months
Secondary	Visual Analogue Scale for Pain		6 weeks
Secondary	Postural Sway		6 weeks
Secondary	SF-36, v1, Physical Function subscale		6 weeks
Secondary	Posteroanterior Spinal Stiffness		6 weeks
Secondary	Sit-to-Stand Maneuver		6 weeks
Secondary	Spinal Manipulation		6 weeks