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Elderly Back Pain: Comparing Chiropractic to Medical Care (HRSA4)
This study has been completed.
Sponsor:
Palmer College of Chiropractic
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Palmer College of Chiropractic
ClinicalTrials.gov Identifier:
NCT00602901
First received: January 15, 2008
Last updated: April 5, 2017
Last verified: April 2017
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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: HVLA-SM Other: LVVA-SM Drug: Usual medical care | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 ]
Secondary Outcome Measures:
- Fear Avoidance Beliefs Questionnaire, physical subscale [ Time Frame: 6 weeks, 3 months, 6 months ]
- Visual Analogue Scale for Pain [ Time Frame: 6 weeks ]
- Postural Sway [ Time Frame: 6 weeks ]
- SF-36, v1, Physical Function subscale [ Time Frame: 6 weeks ]
- Posteroanterior Spinal Stiffness [ Time Frame: 6 weeks ]
- Sit-to-Stand Maneuver [ Time Frame: 6 weeks ]
- Spinal Manipulation [ Time Frame: 6 weeks ]
| 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: 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 Name: (Celebrex, Aleve, Bextra, Naproxen)
|
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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602901
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
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 |
More Information
Publications:
| Responsible Party: | Palmer College of Chiropractic |
| ClinicalTrials.gov Identifier: | NCT00602901 History of Changes |
| Other Study ID Numbers: |
R18HP01423 |
| Study First Received: | January 15, 2008 |
| Last Updated: | April 5, 2017 |
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 Anti-Inflammatory Agents Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cyclooxygenase 2 Inhibitors |
ClinicalTrials.gov processed this record on August 16, 2017