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

Completed

• Conditions: Low Back Pain

• Registration Number: NCT01981382
• Lead Sponsor: University of Connecticut

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-04
• Study First Posted: 2013-11-11
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-10
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. 18-50 years of age;
2. 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
3. comprehend English

Exclusion Criteria

1. <18 or >50 years of age;
2. chronic pain at another site or associated with a painful condition (eg., fibromyalgia, neuropathy, rheumatoid arthritis);
3. previous spinal surgery;
4. presence of neurological deficits;
5. history of comorbidities that affect sensorimotor function (eg., multiple sclerosis, spinal cord injury, diabetes); and
6. untreated psychological disorders (major depression, bipolar disorder, schizophrenia)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Experimental Pain Threshold	6 months	Quantitative sensory testing will be used to evaluate pain sensitivity over time

Secondary Outcome Measures

Name	Time	Method
mRNA expression of pain sensitivity genes	6 months	Expression of pain sensitivity genes will be measured over time