Characterizing the Role of Pain Sensitivity in Acute to P... | NCT01981382

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

NCT01981382

Sponsor

University of Connecticut

Status

Completed

Last Update Posted

Nov 15, 2016Estimated

Enrollment

220Actual

Phase

Not provided

Conditions

Low Back Pain

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01NR013932-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Oct 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Nov 4, 2013

First Submission Date that Met QC Criteria

Nov 4, 2013

First Posted Date

Nov 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2016

Last Update Posted Date

Nov 15, 2016Estimated

Name	Class
National Institute of Nursing Research (NINR)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

220Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Incident cases		Persistent nonspecific low back pain
Controls		Acute low back pain that resolves in <6 months

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Experimental Pain Threshold	Quantitative sensory testing will be used to evaluate pain sensitivity over time	6 months

Secondary Outcomes

Measure	Description	Time Frame
mRNA expression of pain sensitivity genes	Expression of pain sensitivity genes will be measured over time	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-50 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

Exclusion Criteria:

<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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Angela R Starkweather, PhD, RN	University of Connecticut School of Nursing	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26883808	Result	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.
26736025	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.

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms