Trials / Completed
CompletedNCT01981382
Characterizing the Role of Pain Sensitivity in Acute to Persistent Low Back Pain
Characterizing Pain Sensitivity in Persistent Nonspecific Low Back Pain
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 220 (actual)
- Sponsor
- University of Connecticut · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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.
Conditions
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2016-10-01
- Completion
- 2016-10-01
- First posted
- 2013-11-11
- Last updated
- 2016-11-15
Source: ClinicalTrials.gov record NCT01981382. Inclusion in this directory is not an endorsement.