Elderly Back Pain: Comparing Chiropractic to Medical Care (HRSA4)
This study has been completed.
Sponsor:
Palmer College of Chiropractic
Collaborator:
Information provided by:
Palmer College of Chiropractic
ClinicalTrials.gov Identifier:
NCT00602901
First received: January 15, 2008
Last updated: August 31, 2009
Last verified: August 2009
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Subacute Low Back Pain Chronic Low Back Pain |
Other: Spinal manipulation Drug: Usual medical care (Celebrex, Aleve, Bextra, Naproxen) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Elderly Back Pain: Comparing Chiropractic to Medical Care |
Resource links provided by NLM:
Further study details as provided by Palmer College of Chiropractic:
Primary Outcome Measures:
- Roland Morris Disability Questionnaire(RMDQ). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Fear Avoidance Beliefs Questionnaire, physical subscale [ Time Frame: 6 weeks, 3 months, 6 months ] [ Designated as safety issue: No ]
- Visual Analogue Scale for Pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Postural Sway [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- SF-36, v1, Physical Function subscale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Posteroanterior Spinal Stiffness [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Sit-to-Stand Maneuver [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Spinal Manipulation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 240 |
| Study Start Date: | July 2004 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
High-velocity low amplitude spinal manipulation (HVLA-SM)
|
Other: Spinal manipulation
High-velocity low amplitude spinal manipulation (HVLA-SM)
|
|
Experimental: 2
Low-velocity variable amplitude spinal manipulation (LVVA-SM)
|
Other: Spinal manipulation
Low-velocity variable amplitude spinal manipulation (LVVA-SM)
|
|
Active Comparator: 3
Usual medical care
|
Drug: Usual medical care (Celebrex, Aleve, Bextra, Naproxen)
Celebrex: po, 200mg, qd, six weeks; Aleve: po, 220mg, bid, six weeks; Bextra: po, 10mg, qd, six weeks; Naproxen: po, 500mg, bid, six weeks.
|
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| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 maniuplative 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602901
Locations
| United States, Iowa | |
| Palmer Center for Chiropractic Research | |
| Davenport, Iowa, United States, 52803 | |
| The University of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
Sponsors and Collaborators
Palmer College of Chiropractic
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 |
More Information
No publications provided by Palmer College of Chiropractic
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | William C. Meeker, Palmer Colleg of Chiropractic - West |
| ClinicalTrials.gov Identifier: | NCT00602901 History of Changes |
| Other Study ID Numbers: | R18HP01423 |
| Study First Received: | January 15, 2008 |
| Last Updated: | August 31, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Naproxen Celecoxib Valdecoxib Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Cyclooxygenase 2 Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013