Characterizing the Role of Pain Sensitivity in Acute to Persistent Low Back Pain
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.
Low Back Pain
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Characterizing Pain Sensitivity in Persistent Nonspecific Low Back Pain|
- Experimental Pain Threshold [ Time Frame: 6 months ] [ Designated as safety issue: No ]Quantitative sensory testing will be used to evaluate pain sensitivity over time
- mRNA expression of pain sensitivity genes [ Time Frame: 6 months ] [ Designated as safety issue: No ]Expression of pain sensitivity genes will be measured over time
Biospecimen Retention: Samples With DNA
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Persistent nonspecific low back pain
Acute low back pain that resolves in <6 months
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01981382
|Contact: Amy Heineman, BS, RNfirstname.lastname@example.org|
|United States, Virginia|
|Virginia Commonwealth University School of Nursing||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Amy Heineman, BS, RN 804-628-8262 email@example.com|
|Principal Investigator: Angela R Starkweather, PhD, RN|
|Principal Investigator:||Angela R Starkweather, PhD, RN||Virginia Commonwealth University School of Nursing|
|Study Director:||Amy Heineman, BS, RN||Virginia Commonwealth University School of Nursing|