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

NCT01981382 | Completed DMC

• 2 other identifiers: 1R01NR013932-01R01NR013932-01
• Study Type: observational
• Target: 220
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Experimental Pain Threshold

  Quantitative sensory testing will be used to evaluate pain sensitivity over time

  6 months

Secondary Outcomes (1)

• mRNA expression of pain sensitivity genes

  6 months

Study Arms (2)

Incident cases

Persistent nonspecific low back pain

Controls

Acute low back pain that resolves in \<6 months

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• years of age;
• 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
• comprehend English

You may not qualify if:

• \<18 or \>50 years of age;
• chronic pain at another site or associated with a painful condition (eg., fibromyalgia, neuropathy, rheumatoid arthritis);
• previous spinal surgery;
• presence of neurological deficits;
• history of comorbidities that affect sensorimotor function (eg., multiple sclerosis, spinal cord injury, diabetes); and
• untreated psychological disorders (major depression, bipolar disorder, schizophrenia)

Sponsors & Collaborators

• University of Connecticut: lead
• National Institute of Nursing Research (NINR): collaborator

Related Publications (2)

• 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.

  PMID: 26883808 RESULT

• 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.

  PMID: 26736025 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Angela R Starkweather, PhD, RN

  University of Connecticut School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 11, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 15, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share