Bone Marrow Aspiration Pain Study

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01524523
First received: February 1, 2012
Last updated: August 20, 2013
Last verified: June 2013
  Purpose

Background:

- Many people feel pain during and after bone marrow aspiration (collection). Studies suggest that pain may be related to different kinds of inflammation, or the presence of nitric oxide (a normally occurring gas) in the body. Researchers want to study nitric oxide levels in the blood and breath before and after bone marrow collection. They will look at how these levels relate to feelings of pain.

Objectives:

- To better understand pain related to having a bone marrow collection.

Eligibility:

- Individuals at least 18 years of age who are enrolled in a study that requires bone marrow collection.

Design:

  • Participants will be screened with a physical exam, medical history, and blood sample.
  • Participants will provide study blood and breath samples to check nitric oxide levels. Participants will also have a test to measure skin sensitivity to heat and touch.
  • During the collection, participants will keep track of their pain levels.
  • After the collection, participants will keep track of any pain medications they take. They will also record if and when they eat any foods that contain nitrates for about 24 hours.

Condition
Acute Pain
Gene Expression
Nitric Oxide

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Biochemical and Genetic Mechanisms of Acute Clinical Pain During Bone Marrow Aspiration

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Differences over time between whole blood gene expression in the peripheral blood of healthy subjects undergoing an acute pain stimulus.

Secondary Outcome Measures:
  • Quantification and differences in laboratory correlates (particularly plasma nitrite, nitrosated proteins, and cyclic GMP) in health subjects pre- and post-BMA.
  • Quantification of pain sensory perception in healthy subjects

Enrollment: 0
Study Start Date: December 2011
Estimated Study Completion Date: June 2013
Detailed Description:

Abstract:

This project will explore the biochemical mechanisms associated with acute pain produced by bone marrow aspiration in 36 healthy subjects by : 1) Evaluation of any strong relationships of NO metabolism (as measured by plasma nitrite, nitrosated proteins, cyclic GMP, plasma hemoglobin, reticulocytes, as well as markers of inflammation) with the levels of acute pain in healthy subjects and; 2) Identification of differentially expressed genes and proteins as markers for the nature and severity of pain from bone marrow aspiration. Elucidation of these relationships may identify novel targets for intervention leading to attenuation of pain, improved treatment and less impact on quality of life (QOL) and may identify potential mechanisms for the role of NO in other inflammatory or pain syndromes.

Objectives:

The first objective of the study is to characterize genetic expression during acute pain and pain free phases pre and post bone marrow aspiration (BMA). The second objective is to measure at multiple time points levels of exhaled Nitric Oxide (eNO) and other biomarkers in subjects during pre- and post BMA. The third objective is to evaluate acute and experimental pain perception in these subjects.

Population:

This study will recruit healthy subjects (N=36) who have agreed to donate bone marrow.

Design:

This is a prospective, exploratory study of sensory and affective pain in healthy volunteers. Participants will undergo evaluations (eNO, blood collection, and quantitative sensory testing) during a clinic visit to undergo bone marrow aspiration.

Importance:

The purpose of this study is to improve the understanding of the biochemical and molecular genetic mechanisms associated with acute pain in a healthy population by characterizing the leukocyte transcriptome of pain pre- and post BMA. It is hypothesized that analysis of the transcriptome will result in a panel of biomarkers that correlate with acute pain in a healthy population. The successful elucidation of these relationships may identify novel targets for intervention leading to attenuation of pain, improved treatment and less impact on quality of life and functional status.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA FOR SUBJECTS:

All subjects enrolled in the parent protocol are eligible for enrollment in this study provided they have met all the inclusion criteria in the parent protocol and if they meet all of the following criteria:

  • Age greater than or equal to 18 years old.
  • No chronic medication use that in the judgment of the investigators could confound the study or biomarker measurements.
  • Can speak and understand English to complete assessments and scales

EXCLUSION CRITERIA FOR ALL STUDY PARTICIPANTS:

Study participants will be excluded from the study if he/she has one or more of the following:

  • Inability to provide informed consent.
  • Drug or alcohol dependence/abuse within the past 5 years
  • Cigarette smoking or the use of any tobacco products within two years
  • Use of tranquilizers, steroids, and non-steroidal anti-inflammatory agents three or more times per week.
  • Clinically significant medical condition that will confound the analysis of factors associated with pain, such as:

    • Chronic inflammatory disease (i.e. rheumatoid arthritis, systemic lupus erythematosus, cirrhosis)
    • Chronic pain condition
    • Diabetes mellitus
    • Known malignancies
  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: NCT01524523

Sponsors and Collaborators
Investigators
Principal Investigator: Wendy B Smith, Ph.D. National Institutes of Health Clinical Center (CC)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01524523     History of Changes
Other Study ID Numbers: 120001, 12-CC-0001
Study First Received: February 1, 2012
Last Updated: August 20, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Gene Expression
Acute Pain
Nitric Oxide
Pain
Bone Marrow

ClinicalTrials.gov processed this record on July 24, 2014