NCT00341367

Blood Sample Donations to Study the Role of Genes in Pain

Completed Last updated 2 July 2017

What this trial tests

trial in Pain in 320 participants. Completed in 11 March 2010.

Timeline

10 December 2002

11 March 2010

Quick facts

Lead sponsor	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	320
Start date	10 December 2002
Estimated completion	11 March 2010
Sites	1 location across United States

Conditions studied

• Pain — all drugs for Pain →

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Who can join

Eligibility, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study attempts to identify genes that may increase or decrease the likelihood of sciatic pain (shooting pain down the leg) persisting 1 year after treatment of a herniated spinal disc. Many proteins in the nerves, spinal cord, and brain are involved in processing pain. These proteins vary slightly in different people. Animal studies have shown that rats and mice with certain types of proteins experience chronic pain after sciatic injury while those with other types do not. Better information about the role of genes in pain processing may lead to a test for the risk of chronic pain for specific individuals and more effective treatment approaches.

This study will include people who participated in the Maine Lumbar Pain Study of the natural history of spinal pain. The Maine study included patients treated for sciatic pain caused by a herniated disc. In this study, patients who did not improve with medical treatment were referred for surgery to remove the disc. Of those referred for surgery, 275 elected to have the operation, and 232 did not. One year after surgical consultation, leg pain was reduced in 81 percent of patients who underwent surgery. Of those who declined surgery, 56 percent improved after 1 year. This study will look for genetic differences in the non-surgical group that might reveal differences among those who improved and those who did not.

Participants will provide a blood sample (approximately 2 tablespoons) for genetic testing. They will also provide information on the ethnic background of their parents and grandparents. Different gene variants occur in different ethnic groups, so information on ethnic background will help researchers know what gene variants to look for. Participants will complete a questionnaire about their smoking history, because the same protein in the brain that responds to nicotine may also play a part in decreasing or increasing pain. Also, some surgeons believe that smoking can interfere with spinal bone healing. Information from this study will help resolve this question.

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Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.