Clinical trial NCT01842737: PRoGReSS-PS: Patient Response to GRraded Sensory Stimulation: A Pilot Study
Official title: PRoGReSS-PS: Patient Response to GRraded Sensory Stimulation: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
Chiropractic
Spinal Manipulation
Massage
Lead sponsor: Palmer College of Chiropractic
Sponsor class: OTHER
First posted: 2013-04-30
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 will also measure back pain and function with research questionnaires and other measures.

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, the researchers will:

1. Measure the participant's back pain and function using research forms.
2. Test the participant's ability to discern different touch sensations in the low back.
3. Assess the participant's perceptions of the study procedures on research forms during the study and in a short interview at the end of the study.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Back Pain Visual Analogue Scale
timeFrame: 4 Weeks
Secondary outcomes:
measure: Roland Morris Disability Questionnaire
timeFrame: 4 Weeks
measure: Two-Point Discrimination
timeFrame: 4 Weeks
measure: Graphesthesia
timeFrame: 4 Weeks
measure: Line Drawing
timeFrame: 4 Weeks
Other outcomes:
measure: Adverse Events
timeFrame: 4 Weeks
Locations:
city: Davenport
country: United States
facility: Palmer Center for Chiropractic Research
state: Iowa
Study officials:
affiliation: Palmer College of Chiropractic
name: Christine M Goertz, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References: