Status:
COMPLETED
PRoGReSS-PS: Patient Response to GRraded Sensory Stimulation: A Pilot Study
Lead Sponsor:
Palmer College of Chiropractic
Conditions:
Low Back Pain
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
The Patient Response to Graded Sensory Stimulation-Pilot Study (PRoGReSS-PS) will measure back pain perceptions in participants who receive either chiropractic treatment or foot massage. The study wil...
Detailed Description
The Patient Response to Graded Sensory Stimulation Pilot Study (PRoGReSS-PS) will measure back pain perceptions in participants who receive either chiropractic treatment or foot massage. In this study...
Eligibility Criteria
Inclusion
- Age 21-65 Years
- Low Back Pain (LBP) meeting Quebec Task Force (QTF) Classifications 1-6
- Minimum LBP pain level on the 11-point NRS (Worst pain past 24 hours)
- LBP classified as chronic (onset more than 12 weeks previous)
- Written Informed Consent
- No plans to move out of the area in the next 6-8 weeks
- Transportation to come to the clinic on a regular basis
Exclusion
- LBP meeting QTF Classifications 7-11
- Bone and joint pathology contraindicating spinal manipulation including: joint instability; recent spinal or rib fracture, or non-union; severe osteoporosis; spinal or paraspinal tumors; aortic aneurysm \> 5 cm; cauda equina syndrome
- Retention of legal advice related to this or a previous LBP episode or participants with active occupational or personal injuries cases
- Inability to read or verbally comprehend English
- Legally blind even with the aid of glasses and/or contact lenses
- Evidence of alcohol or drug dependence or abuse per self-report or as determined by history and examination
- Depression scores \> 29 (severe) on the Beck Depression Inventory-II
- Unwillingness to postpone use of all other types of manual treatment for LBP except those provided in the study for the duration of the study period
- Co-morbidity requiring coincident clinical management, or prevent delivery of care, or interfering with ability to assess participant health status and/or treatment outcomes
- Co-morbidity requiring referral for serious or potentially serious health concerns
- Inflammatory disease of the spine (e.g. Ankylosing spondylitis, Rheumatoid arthritis)
- Uncontrolled hypertension
- Unable to safely tolerate study procedures
- Need for additional diagnostic procedures other than x-ray or urinalysis
- Pregnancy or seeking to become pregnant during active study phase
- Seeking or receiving compensation for any disability
- Unable or unwilling to comply with study protocol
- Extremity conditions preventing safe massage (e.g., injuries, infections)
- Minimum pain level at each eligibility appointment
- Recent tattoos or piercing in lumbar region (within past 6 months)
- Peripheral neuropathy in the extremities due to safety concerns
- Amputation of any extremity
- Bleeding disorders due to safety concerns
- Currently taking any opioid medication due to impact on pain perception
- Unable to identify at least 3 out of 5 letters drawn on dominant hand during baseline examination due to somatosensory outcome measure (graphesthesia)
- Fracture in back, hips or ribs past 8 weeks
- History of spinal surgery or spinal injections to low back
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01842737
Start Date
April 1 2013
End Date
December 1 2013
Last Update
March 30 2017
Active Locations (1)
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1
Palmer Center for Chiropractic Research
Davenport, Iowa, United States, 52803