Characterizing the Role of Pain Sensitivity in Acute to Persistent Low Back Pain
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|ClinicalTrials.gov Identifier: NCT01981382|
Recruitment Status : Completed
First Posted : November 11, 2013
Last Update Posted : November 15, 2016
|Condition or disease|
|Low Back Pain|
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 Type :||Observational|
|Actual Enrollment :||220 participants|
|Observational Model:||Case Control|
|Official Title:||Characterizing Pain Sensitivity in Persistent Nonspecific Low Back Pain|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Persistent nonspecific low back pain
Acute low back pain that resolves in <6 months
- Experimental Pain Threshold [ Time Frame: 6 months ]Quantitative sensory testing will be used to evaluate pain sensitivity over time
- mRNA expression of pain sensitivity genes [ Time Frame: 6 months ]Expression of pain sensitivity genes will be measured over time
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981382
|Principal Investigator:||Angela R Starkweather, PhD, RN||University of Connecticut School of Nursing|