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NCT00341367 · ClinicalTrials.gov registry record

Blood Sample Donations to Study the Role of Genes in Pain

A clinical trial, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

Completed
Registry status
320
Enrollment target

NCT00341367: Completed study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

NCT00341367 is a clinical trial that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 320 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00341367 has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

COMPLETED
Registry status
320 participants
Enrollment target

Study Summary

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. Info

Trial Details

FieldValue
Enrollment Target 320 participants
Start Date 2002-12-10
Est. Completion 2010-03-11

What the finished NCT00341367 record still lists

NCT00341367 is an observational study that tracks outcomes without assigning an intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT00341367 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00341367 about?

NCT00341367 is a clinical study titled "Blood Sample Donations to Study the Role of Genes in Pain". 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 sligh...

What is the current status of trial NCT00341367?

This trial is currently completed. The enrollment target is 320 participants. The study started on 2002-12-10. Estimated completion is 2010-03-11.

Who is sponsoring clinical trial NCT00341367?

This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00341367, the US trial registry maintained by the National Library of Medicine. NCT00341367 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.