Characterizing the Role of Pain Sensitivity in Acute to Persistent Low Back Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Characterizing Pain Sensitivity in Persistent Nonspecific Low Back Pain

Conditions
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Low Back Pain

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Incident cases<br>Persistent nonspecific low back pain | |
| Controls<br>Acute low back pain that resolves in <6 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experimental Pain Threshold | Quantitative sensory testing will be used to evaluate pain sensitivity over time | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mRNA expression of pain sensitivity genes | Expression of pain sensitivity genes will be measured over time | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, pain sensitivity, genes, gene expression,, quantitative sensory testing