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

Low Back Pain Clinical Trial

Official title:

Characterizing Pain Sensitivity in Persistent Nonspecific Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01981382
• Other study ID #: 1R01NR013932-01
• Secondary ID: R01NR013932-01
• Status: Completed
• Phase: N/A
• First received: November 4, 2013
• Last updated: November 10, 2016
• Start date: October 2013
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Hypersensitivity
• Low Back Pain

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut	National Institute of Nursing Research (NINR)

References & 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) — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Experimental Pain Threshold	Quantitative sensory testing will be used to evaluate pain sensitivity over time	6 months	No
Secondary	mRNA expression of pain sensitivity genes	Expression of pain sensitivity genes will be measured over time	6 months	No