Low-Dose Radiation to Prevent Complications of Back Surgery (NCT00018876) | Clinical Trial Compass
CompletedPhase 1
Low-Dose Radiation to Prevent Complications of Back Surgery
United States46 participantsStarted 2000-10
Plain-language summary
More than 10,000 people each year in the United States have "failed back surgery syndrome" caused by scars that form around the outer surface of the spinal cord. Such scarring, known as peridural fibrosis, is common after back surgery known as either lumbar discectomy or laminectomy. Peridural fibrosis may cause recurring low back pain or leg pain after surgery. Operating again to remove the scar tissue often leads to more scarring.
Researchers have not previously studied radiation as a way to prevent peridural fibrosis. We will test whether low-dose radiation given 24 hours before surgery will decrease the amount of peridural fibrosis and if this reduction will lead to improved results of surgery. Half of the participants will receive radiation before surgery and the other half will not. We will evaluate patients at followup visits 1, 3, 6, and 12 months after surgery with a physical exam and questionnaire. At 12 months, we will obtain magnetic resonance imaging (MRI) of the lower spine.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Patients with a clinical diagnosis of failed back surgery syndrome.
* Previous surgery at either the L4-5 or L5-S1 levels.
* Patients with peridural fibrosis around the symptomatic nerve root (either L5 or S1) on contrast-enhanced MR imaging.
* Willing and able to be treated and followed at the University of Pittsburgh Medical Center.
* Cooperative individuals with no language barrier, and who sign an informed consent form.
Exclusion Criteria:
* Patients less than 18 years of age.
* Patients with prior radiotherapy to the same region of the back.
* Female patients with a functioning, intact reproductive system are ineligible until a pregnancy test performed within 48 hours of radiotherapy rules out pregnancy.
* Patients with organic brain syndrome or dementia.
* Severe vascular, pulmonary or coronary artery disease which would place them at an unacceptably high risk to undergo general anesthesia.
* Myocardial infarction within the last 6 months.
* Metastatic cancer.
* Excessive alcohol consumption or evidence of drug use.
* Spondylolisthesis requiring surgical fusion (greater than 5 mm of vertebral slippage.)
* Unable to undergo MR imaging.