Trial record 13 of 203 for:    Open Studies | "Low Back Pain"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Virginia Commonwealth University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01981382
First received: November 4, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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.


Condition
Low Back Pain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Characterizing Pain Sensitivity in Persistent Nonspecific Low Back Pain

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Experimental Pain Threshold [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Quantitative sensory testing will be used to evaluate pain sensitivity over time


Secondary Outcome Measures:
  • mRNA expression of pain sensitivity genes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Expression of pain sensitivity genes will be measured over time


Biospecimen Retention:   Samples With DNA

whole blood


Estimated Enrollment: 220
Study Start Date: October 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Incident cases
Persistent nonspecific low back pain
Controls
Acute low back pain that resolves in <6 months

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01981382

Contacts
Contact: Amy Heineman, BS, RN 8046288262 s2aheine@vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University School of Nursing Recruiting
Richmond, Virginia, United States, 23298
Contact: Amy Heineman, BS, RN    804-628-8262    s2aheine@vcu.edu   
Principal Investigator: Angela R Starkweather, PhD, RN         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Angela R Starkweather, PhD, RN Virginia Commonwealth University School of Nursing
Study Director: Amy Heineman, BS, RN Virginia Commonwealth University School of Nursing
  More Information

Additional Information:
No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01981382     History of Changes
Other Study ID Numbers: 1R01NR013932-01, R01NR013932-01
Study First Received: November 4, 2013
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
low back pain
pain sensitivity
genes
gene expression,
quantitative sensory testing

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014