Bone Marrow Aspiration Pain Study

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.

- 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