Elderly Back Pain: Comparing Chiropractic to Medical Care (HRSA4)
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ClinicalTrials.gov Identifier: NCT00602901 |
Recruitment Status
:
Completed
First Posted
: January 28, 2008
Last Update Posted
: April 6, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Subacute Low Back Pain Chronic Low Back Pain | Other: HVLA-SM Other: LVVA-SM Drug: Usual medical care | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Elderly Back Pain: Comparing Chiropractic to Medical Care |
Study Start Date : | July 2004 |
Actual Primary Completion Date : | October 2006 |
Actual Study Completion Date : | March 2007 |

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)
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Experimental: LVVA-SM
Low-velocity variable amplitude spinal manipulation (LVVA-SM)
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Other: LVVA-SM
Low-velocity variable amplitude spinal manipulation (LVVA-SM)
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Active Comparator: Usual Medical Care
Usual medical care - (Celebrex, Aleve, Bextra, Naproxen)
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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)
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- Roland Morris Disability Questionnaire(RMDQ). [ Time Frame: 6 weeks ]
- 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 ]

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Ages Eligible for Study: | 55 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00602901
United States, Iowa | |
Palmer Center for Chiropractic Research | |
Davenport, Iowa, United States, 52803 | |
The University of Iowa | |
Iowa City, Iowa, United States, 52242 |
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 of Results:
Responsible Party: | Palmer College of Chiropractic |
ClinicalTrials.gov Identifier: | NCT00602901 History of Changes |
Other Study ID Numbers: |
R18HP01423 |
First Posted: | January 28, 2008 Key Record Dates |
Last Update Posted: | April 6, 2017 |
Last Verified: | April 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 |