Overview

This trial has been completed.

Condition low back pain
Sponsor University of Connecticut
Collaborator National Institute of Nursing Research (NINR)
Start date October 2013
End date October 2016
Trial size 220 participants
Trial identifier NCT01981382, 1R01NR013932-01, R01NR013932-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Persistent nonspecific low back pain
Acute low back pain that resolves in <6 months

Primary Outcomes

Measure
Experimental Pain Threshold
time frame: 6 months

Secondary Outcomes

Measure
mRNA expression of pain sensitivity genes
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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)

Additional Information

Official title Characterizing Pain Sensitivity in Persistent Nonspecific Low Back Pain
Principal investigator Angela R Starkweather, PhD, RN
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Connecticut.