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Clinical Trials/NCT01981382
NCT01981382
Completed
Not Applicable

Characterizing Pain Sensitivity in Persistent Nonspecific Low Back Pain

University of Connecticut0 sites220 target enrollmentOctober 2013
ConditionsLow Back Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
University of Connecticut
Enrollment
220
Primary Endpoint
Experimental Pain Threshold
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

This research study will examine whether enhanced pain sensitivity increases the risk of persistent low back pain. The study will address the highly prevalent and costly condition of persistent low back pain and a major obstacle for the implementation of clinical strategies to improve patient outcomes. The knowledge gained from this study may lead to a better understanding of the biological mechanisms that contribute to persistent low back pain and will inform future work to develop predictive measures of persistent low back pain risk, evaluative measures to examine treatment efficacy, and possibly biomarker assay(s) to identify patients who are at increased risk of persistent low back pain.

Detailed Description

The specific aims (SA) of the proposed study are to: Specific Aim 1. Characterize (A) the differences in pain sensitivity between incident cases and controls at low back pain onset and (B) changes in pain sensitivity over time in incident cases. H1.A Incident cases will have increased pain sensitivity compared with controls at low back pain onset. H1.B Incident cases will have increased pain sensitivity over time. Specific Aim 2. Compare (A) genetic polymorphisms at low back pain onset between incident cases and controls and mRNA expression of candidate genes at LBP onset and at 6 weeks between incident cases and controls; and (B) differential expression levels of candidate genes over time in incident cases. H2.A Incident cases will have a higher frequency of polymorphisms and differential expression levels of candidate genes at low back pain onset compared with controls. H2.B Examine expression levels of candidate genes over time in incident cases. Specific Aim 3. Determine the contribution of enhanced pain sensitivity, cofactors (clinical/psychosocial/environmental), genetic polymorphisms, and mRNA expression of candidate genes on the risk of persistent low back pain.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
October 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18-50 years of age;
  • diagnosed with an acute episode of nonspecific LBP present for \>24 hours but \<4 weeks duration and preceded by at least 1 pain-free month; and
  • comprehend English

Exclusion Criteria

  • \<18 or \>50 years of age;
  • chronic pain at another site or associated with a painful condition (eg., fibromyalgia, neuropathy, rheumatoid arthritis);
  • previous spinal surgery;
  • presence of neurological deficits;
  • history of comorbidities that affect sensorimotor function (eg., multiple sclerosis, spinal cord injury, diabetes); and
  • untreated psychological disorders (major depression, bipolar disorder, schizophrenia)

Outcomes

Primary Outcomes

Experimental Pain Threshold

Time Frame: 6 months

Quantitative sensory testing will be used to evaluate pain sensitivity over time

Secondary Outcomes

  • mRNA expression of pain sensitivity genes(6 months)

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