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Blood Sample Donations to Study the Role of Genes in Pain

NCT00341367 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 320

Last updated 2017-07-02

No results posted yet for this 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. Information from this study will help resolve this question.

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Conditions

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    lead NIH

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-10
Completion
2010-03-11

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00341367 on ClinicalTrials.gov