Predicting Patients' Response to Spinal Manipulation
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ClinicalTrials.gov Identifier: NCT00285649 |
Recruitment Status :
Completed
First Posted : February 2, 2006
Results First Posted : July 5, 2017
Last Update Posted : August 16, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Low Back Pain | Other: HVLA-SM Other: LVVA-SM Other: Usual Medical Care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 192 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Predicting Patients' Response to Spinal Manipulation |
Study Start Date : | July 2004 |
Actual Primary Completion Date : | October 2006 |
Actual Study Completion Date : | March 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: HVLA-SM
HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation
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Other: HVLA-SM
HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation |
Experimental: LVVA-SM
LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation
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Other: LVVA-SM
LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation |
Active Comparator: Usual Medical Care
Usual Medical Care, Active Comparator, advice, exercises and medications
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Other: Usual Medical Care
Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen) |
- Roland Morris Low Back Pain Disability Questionnaire (RMDQ) [ Time Frame: Mean change from baseline to week 3 ]The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. This outcome displays the mean change in RMDQ from baseline to week 3.

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Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age 21 to 55
- Idiopathic mechanical low back pain (LBP) matching classification 1-4 of the Quebec Task Force.
- LBP classified as subacute (onset 4-12 weeks previous) or chronic (onset more than 12 weeks previous), with the current episode occurring at least four weeks prior to the date of contact with the clinic: In order to exclude the greatest proportion of LBP patients that have a favorable natural history of improvement.
- Written Informed Consent
- A minimum baseline score on the Roland Morris Disability Questionnaire (RMQ) of 6 points.
Exclusion Criteria:
- LBP from other somatic tissues as determined by history, examination, and course (e.g. pain referred from visceral conditions).
- LBP diagnosis not meeting Classifications 1 through 4 of the Quebec Task Force, especially the following: low back pain associated with frank radiculopathy defined as typical shooting leg pain; positive straight leg-raising test; an altered lower extremity reflex; a dermatomal sensory deficit; at least one of the following: progressive unilateral muscle weakness or motor loss, or symptoms of cauda equina compression; and CT or MRI evidence of related anatomical pathology (e.g. abnormal disc, stenosis).
- Co-morbid pathology or poor health conditions in patients; Co-morbid conditions and general poor health significantly complicate the prognosis of LBP, and inject a variety of uncontrollable factors in case-management, not to mention experimental analysis and interpretation. Patients who have case histories and physical examination findings indicating other that average good health will be excluded from the study.
- Bone and joint pathology contraindicating patient for SM of the lumbar spine and pelvis: Patients with spinal fractures, tumors, infections, arthropathies, and significant osteoporosis will be referred to appropriate health care.
- Other contraindications for SM of the lumbar spine and pelvis (e.g. bleeding disorders or anticoagulant therapy, extreme obesity).
- Retention of legal advice related to this or a previous LBP episode: Patients with occupational or personal injuries will not be automatically excluded from the study unless they answer yes to a specific question about the retention of legal advice with respect to their LBP episode at the baseline interview.
- Pregnancy: Pregnancy is a contraindication for exposing a patient to ionizing radiation and is a confounding factor in the usual course of LBP.
- Inability to read or verbally comprehend English.
- Clear evidence of narcotic or other drug abuse as determined by history and examination: injects significant confounding factors with respect to internal validity and feasibility.
- Major clinical depression: Patients with scores greater than 17 on the Beck Depression Inventory will be excluded from the study. Patients with evidence of other psychiatric disorders as determined by history and exam will also be excluded.
- Use of manipulative care for any reason within the past 3 months as determined by history: to exclude the possibility of carryover effects.
- Unwillingness to postpone use of all other types of manual treatment for LBP except those provided in the study (including chiropractic and osteopathic SM, physical therapy, and massage) for the duration of the study period: to eliminate confounding effects.

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): NCT00285649
United States, Iowa | |
Palmer Center for Chiropractic Research | |
Davenport, Iowa, United States, 52803 |
Principal Investigator: | William C Meeker, DC, M.P.H. | Palmer Chiropractic College | |
Principal Investigator: | David Wilder, PhD | University of Iowa |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Palmer College of Chiropractic |
ClinicalTrials.gov Identifier: | NCT00285649 |
Other Study ID Numbers: |
U19P3 |
First Posted: | February 2, 2006 Key Record Dates |
Results First Posted: | July 5, 2017 |
Last Update Posted: | August 16, 2017 |
Last Verified: | July 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Spinal Manipulation |
Low Back Pain Back Pain Pain Neurologic Manifestations |