Clinical trial NCT01981382: Characterizing the Role of Pain Sensitivity in Acute to Persistent Low Back Pain
Official title: Characterizing Pain Sensitivity in Persistent Nonspecific Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: low back pain
pain sensitivity
genes
gene expression,
quantitative sensory testing
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2013-11-11
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men and women between the ages of 18-50 years of age who are diagnosed with an acute nonspecific LBP episode defined as pain anywhere in the region of the low back bound superiorly by T12 and inferiorly by the buttock crease, which has been present for \>24 hours but \<4 weeks duration and was preceded by at least 1 pain-free month.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Experimental Pain Threshold
timeFrame: 6 months
Secondary outcomes:
measure: mRNA expression of pain sensitivity genes
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Connecticut School of Nursing
name: Angela R Starkweather, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Starkweather AR, Lyon DE, Kinser P, Heineman A, Sturgill JL, Deng X, Siangphoe U, Elswick RK, Greenspan J, Dorsey SG. Comparison of Low Back Pain Recovery and Persistence: A Descriptive Study of Characteristics at Pain Onset. Biol Res Nurs. 2016 Jul;18(4):401-10. doi: 10.1177/1099800416631819. Epub 2016 Feb 16.
citation: Starkweather AR, Ramesh D, Lyon DE, Siangphoe U, Deng X, Sturgill J, Heineman A, Elswick RK Jr, Dorsey SG, Greenspan J. Acute Low Back Pain: Differential Somatosensory Function and Gene Expression Compared With Healthy No-Pain Controls. Clin J Pain. 2016 Nov;32(11):933-939. doi: 10.1097/AJP.0000000000000347.