Characterizing the Role of Pain Sensitivity in Acute to Persistent Low Back Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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

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Low Back Pain

Keywords

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low back pain pain sensitivity genes gene expression, quantitative sensory testing

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Incident cases

Persistent nonspecific low back pain

No interventions assigned to this group

Controls

Acute low back pain that resolves in \<6 months

No interventions assigned to this group

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela R Starkweather, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut School of Nursing

Countries

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United States

References

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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.

Reference Type RESULT

PMID: 26883808 (View on PubMed)

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.

Reference Type RESULT

PMID: 26736025 (View on PubMed)

Other Identifiers

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R01NR013932-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01NR013932-01