View Clinical Trial (Medical Research Study)
Effect of Spinal Manipulation on Sensorimotor Functions in Back Pain Patients - NCT00830596-52803(Clinical Trial 265911)
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| City: |
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Davenport |
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State:
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IA |
| Zip Code: |
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52803 |
| Conditions: |
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Low Back Pain |
| Purpose: |
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The long-term goal for this study is to understand the physiological mechanisms of various
forms of spinal manipulation in order to refine and improve this therapy for appropriately
selected patients. The objective of this study is to assess the effects of high-velocity
low-amplitude spinal manipulation and low-velocity variable amplitude spinal manipulation on
three types of sensorimotor abilities in patients with low back pain.
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| Study summary: |
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In collaboration with the University of Iowa, the Palmer Center for Chiropractic Research
will pursue the following specific aims: 1) To determine the immediate pre-to-post changes
from HVLA-SM and LVVA-SM to the lumbo-pelvic region, compared to a control group receiving
light effleurage and a sham mechanically assisted adjustment, on sensorimotor function as
measured by: lumbo-pelvic repositioning ability, standing postural sway, and response to
sudden trunk loading; 2) To determine the effects of 2 weeks (4 applications @ 2 per week)
of HVLA-SM and LVVA-SM to the lumbo-pelvic region, compared to a control group receiving
light effleurage and a sham mechanically assisted adjustment, on sensorimotor function as
measured by: lumbo-pelvic repositioning ability, standing postural sway and response to
sudden trunk loading; 3) To determine the effects of 6 weeks (12 applications @ 2 per week)
of HVLA-SM and LVVA-SM to the lumbo-pelvic region on sensorimotor function as measured by:
Lumbo-pelvic repositioning ability, standing postural sway, and response to sudden truck
loading; 4) To explore whether changes in sensorimotor function are associated with changes
in self-reported back pain intensity, related disability, or health status at 2 weeks (after
4 SM Visits) and at 6 weeks (after 12 SM Visits); 5) To determine if sensorimotor function
changes are greater in patients a priori clinically classified as being most appropriate for
manipulation.; 6)Describe the sensorimotor and clinical effects of 4 weeks of full spine and
extremity (clinician's choice) care following 2 weeks of receiving light effleurage and a
sham mechanically assisted adjustment for participants with low back pain; and 7) To explore
if there is an association between: a. DC characterization of the quality of the SM (as
rated on a survey) and the biomechanics of the SM (as measured by the force-time profile,
biomechanical assessments, and videotape), and b. DC and participant characterization of
quality of the SM (as rated on surveys). |
| Criteria: |
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Inclusion Criteria:
- 21 to 65 years old
- Low back pain (LBP) score an 11 point numerical rating scale: (must be > 4 at the
Phone Screening OR Baseline 1 Visit) AND (must be > 2 at the Phone Screen, Baseline 1
AND Baseline 2 Visits)
- Acute (less than 7 days), sub-acute (7 days to 7 weeks), or chronic (more than 7
weeks) LBP matching classifications 1, 2, or 3 of the Quebec Task Force (QTF)
Classification system - QTF 1: Pain without radiation, QTF 2: Pain + radiation to
proximal extremity, QTF 3: Pain + radiation to distal extremity, QTF 7: Spinal
stenosis
- Written informed consent (ICD1, ICD2 and ICD3)
Exclusion Criteria:
- Ongoing treatment for low back pain by other health care providers - 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.
- Co-morbidities Bleeding Disorders Bone and Joint Pathology Cauda Equina Syndrome
Contra-indication to spinal manipulation, in general Current or Pending Litigation
General Poor Health Inflammatory or Destructive tissue changes to the spine
Neuromuscular Diseases Obesity Osteoporosis Peripheral Neuropathies Spinal Surgery
Suspicion of drug or alcohol abuse Uncontrolled hypertension Vascular claudication
- Quebec Task Force (QTF) on Spinal Disorders QTF 4: Pain + radiation to upper/lower
limb with neurologic signs QTF 5: Presumptive compression of a spinal nerve root on a
simple roentgenogram QTF 6: Compression of a spinal nerve root confirmed by specific
imaging techniques QTF 8: Postsurgical status, 1-6 months after intervention QTF 9:
Postsurgical status, >6 months after intervention 9.1: Asymptomatic 9.2: Symptomatic
QTF 10: Chronic pain syndrome QTF 11: Other diagnoses
- Pregnant or nursing women
- Pacemaker
- Inability to read or verbally comprehend English
- Any Joint Replacement
- Use of spinal manipulation within the past 4 weeks. If participants are willing to
delay study enrollment until four weeks post spinal manipulative therapy, then we
will schedule accordingly until this criterion is met
- Sensitivity to tape used during the biomechanical assessments
- If the Study Clinician believes that diagnostic procedures other than x-rays or
dipstick urinalysis are necessary to diagnose a participant's condition, then the
participant will be excluded
- Beck Depression Inventory-II greater than or equal to 29
- Retention of legal advice and an open or pending case for a health-related condition |
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| Study is available at: |
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Palmer College of Chiropractic
Davenport, IA 52803
United States
Primary Contact:
Christine G Choate, DC, PhD
Email: christine.choate@palmer.edu
Phone: 563-884-5159
Secondary Contact:
Christine M Goertz, DC, PhD
Email: christine.choate@palmer.edu
Phone: 563-884-5159 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
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