Low-Dose Radiation to Prevent Complications of Back Surgery

Failed Back Surgery Syndrome Clinical Trial

Official title:

Radiotherapy to Prevent Fibrosis After Lumbar Laminectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00018876
• Other study ID #: R21AR047121
• Secondary ID: R21AR047121NIAMS
• Status: Completed
• Phase: Phase 1
• First received: July 5, 2001
• Last updated: June 6, 2013
• Start date: October 2000
• Est. completion date: October 2002

Study information

• Verified date: March 2006
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

Researchers have long known that low-dose radiation inhibits fibroblast and osteoblast activity. Studies in humans have shown that perioperative radiation therapy is a useful way to prevent both keloid and heterotopic bone formation. However, researchers have not previously studied radiation as a means to inhibit peridural fibrosis. Our previous studies of both rat and dog models showed a significant reduction in peridural fibrosis after laminectomy using low-dose external beam radiation (700 cGy) given 24 hours prior to surgery. Based on our results from these animal studies, we will test whether (1) low-dose radiation given 24 hours before surgery will decrease the amount of peridural fibrosis in people and (2) this reduction in peridural fibrosis will lead to improved results of surgery.

For this study, we will enroll 46 patients with failed back surgery syndrome believed to be secondary to perineural fibrosis in a randomized, double-blinded, controlled clinical trial. We will assign patients to one of two groups before surgery: preoperative radiation (treatment group) or no preoperative radiation (control group). We will treat half of the patients with external beam radiation before re-exploration and decompression of their peridural fibrosis (treatment group) and perform re-exploration and decompression in the other half without preoperative radiation (control group).

All patients will undergo simulation radiation treatment planning and will not know if they received radiation or not. For patients randomized to receive preoperative radiation, we will administer a single dose of 700 cGy to a 6.0-cm-wide field centered on the spinal cord at the affected level, using a 6 MV Varian 600C linear accelerator. We will administer treatment with two fields angled 45 degrees from the vertical plane so that the skin surface for the proposed incision will not be irritated. This should prevent any wound healing problems. Only the radiation oncologist and research assistant will know whether radiation was administered. The patient and the surgeon will be masked as to the treatment.

The neurosurgeon co-investigators will perform the same surgical procedure on all patients 24 hours after their radiation (or sham) treatment. We will give all patients preoperative antibiotics. The surgeon will reopen the previous midline posterior lumbar skin incision and dissect the subcutaneous tissue away from the spinous process and laminae. Once the surgeon has adequately exposed the previous surgical site, he or she will place a self-retaining retractor. The surgeon will decompress the nerve by removing the scar tissue from around the nerve root and thecal sac. The surgeon will also remove any intravertebral disc material thought to be causing nerve root compression. On completion of the operation, the surgeon will stop bleeding with electrocautery, irrigate the wound with antibiotic, and close the wound in layers. In general, the hospital stay after surgery is one night. The patient begins gradual ambulation on the evening of surgery.

We will administer the North American Spine Society (NASS) Lumbar Spine Outcome Assessment to patients before treatment and at followup visits to assess their physical functioning. We will also use the NASS questionnaire to collect demographic and lifestyle information at baseline and to assess patient expectations regarding treatment and level of satisfaction with the treatment during the followup period. We will do a physical examination and administer the patient-reported questionnaire prior to surgery and at 1, 3, 6, and 12 months after surgery. We will obtain magnetic resonance (MR) imaging of the lumbar spine 12 months after treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome
• Fibrosis
• Postdiscectomy Epidural Fibrosis
• Postlaminectomy Syndrome
• Postoperative Complications
• Spinal Diseases
• Syndrome

Intervention

Procedure:
• Lumbar nerve root decompression

• Preoperative low-dose external beam radiation

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (19)

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Long DM. Failed back surgery syndrome. Neurosurg Clin N Am. 1991 Oct;2(4):899-919. Review. — View Citation

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Nguyen CM, Haughton VM, Ho KC, An HS. MR contrast enhancement: an experimental study in postlaminectomy epidural fibrosis. AJNR Am J Neuroradiol. 1993 Jul-Aug;14(4):997-1002. — View Citation

North RB, Campbell JN, James CS, Conover-Walker MK, Wang H, Piantadosi S, Rybock JD, Long DM. Failed back surgery syndrome: 5-year follow-up in 102 patients undergoing repeated operation. Neurosurgery. 1991 May;28(5):685-90; discussion 690-1. — View Citation

Porchet F, Lombardi D, de Preux J, Pople IK. Inhibition of epidural fibrosis with ADCON-L: effect on clinical outcome one year following re-operation for recurrent lumbar radiculopathy. Neurol Res. 1999;21 Suppl 1:S51-60. — View Citation

Ross JS, Robertson JT, Frederickson RC, Petrie JL, Obuchowski N, Modic MT, deTribolet N. Association between peridural scar and recurrent radicular pain after lumbar discectomy: magnetic resonance evaluation. ADCON-L European Study Group. Neurosurgery. 1996 Apr;38(4):855-61; discussion 861-3. — View Citation

Yukawa Y, Kato F, Kajino G, Nakamura S. Serial gadolinium-enhanced MR imaging after lumbar disc resection: observation of the affected root. J Spinal Disord. 1997 Oct;10(5):404-9. — View Citation

* Note: There are 19 references in all — Click here to view all references