Clinical trial NCT00602901: Elderly Back Pain: Comparing Chiropractic to Medical Care
Official title: Elderly Back Pain: Comparing Chiropractic to Medical Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Subacute Low Back Pain
Chronic Low Back Pain
Lead sponsor: Palmer College of Chiropractic
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2008-01-28
Enrollment: 240
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Roland Morris Disability Questionnaire(RMDQ).
timeFrame: 6 weeks
Secondary outcomes:
measure: Fear Avoidance Beliefs Questionnaire, physical subscale
timeFrame: 6 weeks, 3 months, 6 months
measure: Visual Analogue Scale for Pain
timeFrame: 6 weeks
measure: Postural Sway
timeFrame: 6 weeks
measure: SF-36, v1, Physical Function subscale
timeFrame: 6 weeks
measure: Posteroanterior Spinal Stiffness
timeFrame: 6 weeks
measure: Sit-to-Stand Maneuver
timeFrame: 6 weeks
measure: Spinal Manipulation
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Davenport
country: United States
facility: Palmer Center for Chiropractic Research
state: Iowa
city: Iowa City
country: United States
facility: The University of Iowa
state: Iowa
Study officials:
affiliation: Palmer College of Chiropractic
name: William C Meeker, DC, M.P.H.
role: PRINCIPAL_INVESTIGATOR
affiliation: Palmer College of Chiropractic
name: Maria A Hondras, DC, MPH
role: STUDY_DIRECTOR
References:
citation: 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.
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;14(8):983-92. doi: 10.1089/acm.2008.0066.