NCT00018876

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2000

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2001

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 9, 2001

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2002

Completed
Last Updated

June 7, 2013

Status Verified

March 1, 2006

First QC Date

July 5, 2001

Last Update Submit

June 6, 2013

Conditions

Failed Back Surgery SyndromePostlaminectomy SyndromePostdiscectomy Epidural Fibrosis

Keywords

Epidural fibrosisFailed back surgery syndromePostlaminectomy syndromeLumbar laminectomyRadiotherapyRadiationPerineural scar formationPeridural fibrosisBack surgery

Interventions

Lumbar nerve root decompressionPROCEDURE
Preoperative low-dose external beam radiationPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (19)

  • Abitbol JJ, Lincoln TL, Lind BI, Amiel D, Akeson WH, Garfin SR. Preventing postlaminectomy adhesion. A new experimental model. Spine (Phila Pa 1976). 1994 Aug 15;19(16):1809-14. doi: 10.1097/00007632-199408150-00004.

    PMID: 7973979BACKGROUND

  • Brotchi J, Pirotte B, De Witte O, Levivier M. Prevention of epidural fibrosis in a prospective series of 100 primary lumbo-sacral discectomy patients: follow-up and assessment at re-operation. Neurol Res. 1999;21 Suppl 1:S47-50. doi: 10.1080/01616412.1999.11741027.

    PMID: 10214572BACKGROUND

  • Daltroy LH, Cats-Baril WL, Katz JN, Fossel AH, Liang MH. The North American spine society lumbar spine outcome assessment Instrument: reliability and validity tests. Spine (Phila Pa 1976). 1996 Mar 15;21(6):741-9. doi: 10.1097/00007632-199603150-00017.

    PMID: 8882698BACKGROUND

  • Dullerud R, Graver V, Haakonsen M, Haaland AK, Loeb M, Magnaes B. Influence of fibrinolytic factors on scar formation after lumbar discectomy. A magnetic resonance imaging follow-up study with clinical correlation performed 7 years after surgery. Spine (Phila Pa 1976). 1998 Jul 1;23(13):1464-9. doi: 10.1097/00007632-199807010-00007.

    PMID: 9670398BACKGROUND

  • Fandino J, Botana C, Viladrich A, Gomez-Bueno J. Reoperation after lumbar disc surgery: results in 130 cases. Acta Neurochir (Wien). 1993;122(1-2):102-4. doi: 10.1007/BF01446994.

    PMID: 8333299BACKGROUND

  • Geisler FH. Prevention of peridural fibrosis: current methodologies. Neurol Res. 1999;21 Suppl 1:S9-22. doi: 10.1080/01616412.1999.11741021.

    PMID: 10214566BACKGROUND

  • Gerszten PC, Moossy JJ, Bahri S, Kalend A, Martinez AJ. Inhibition of peridural fibrosis after laminectomy using low-dose external beam radiation in a rat model. Neurosurgery. 1999 Mar;44(3):597-602; discussion 602-3. doi: 10.1097/00006123-199903000-00090.

    PMID: 10069597BACKGROUND

  • Grane P, Tullberg T, Rydberg J, Lindgren L. Postoperative lumbar MR imaging with contrast enhancement. Comparison between symptomatic and asymptomatic patients. Acta Radiol. 1996 May;37(3 Pt 1):366-72. doi: 10.1177/02841851960371P177.

    PMID: 8845271BACKGROUND

  • Hinton JL Jr, Warejcka DJ, Mei Y, McLendon RE, Laurencin C, Lucas PA, Robinson JS Jr. Inhibition of epidural scar formation after lumbar laminectomy in the rat. Spine (Phila Pa 1976). 1995 Mar 1;20(5):564-70; discussion 579-80. doi: 10.1097/00007632-199503010-00011.

    PMID: 7604326BACKGROUND

  • Jonsson B, Stromqvist B. Repeat decompression of lumbar nerve roots. A prospective two-year evaluation. J Bone Joint Surg Br. 1993 Nov;75(6):894-7. doi: 10.1302/0301-620X.75B6.8245078.

    PMID: 8245078BACKGROUND

  • Lo TC, Seckel BR, Salzman FA, Wright KA. Single-dose electron beam irradiation in treatment and prevention of keloids and hypertrophic scars. Radiother Oncol. 1990 Nov;19(3):267-72. doi: 10.1016/0167-8140(90)90153-n.

    PMID: 2126387BACKGROUND

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

    PMID: 1840393BACKGROUND

  • Maroon JC, Abla A, Bost J. Association between peridural scar and persistent low back pain after lumbar discectomy. Neurol Res. 1999;21 Suppl 1:S43-6. doi: 10.1080/01616412.1999.11741026.

    PMID: 10214571BACKGROUND

  • 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.

    PMID: 8352176BACKGROUND

  • 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.

    PMID: 1831546BACKGROUND

  • 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. doi: 10.1080/01616412.1999.11741028.

    PMID: 10214573BACKGROUND

  • 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.

    PMID: 8692415BACKGROUND

  • 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.

    PMID: 9355057BACKGROUND

  • Gerszten PC, Moossy JJ, Flickinger JC, Welch WC. Low-dose radiotherapy for the inhibition of peridural fibrosis after reexploratory nerve root decompression for postlaminectomy syndrome. J Neurosurg. 2003 Oct;99(3 Suppl):271-7. doi: 10.3171/spi.2003.99.3.0271.

    PMID: 14563144RESULT

MeSH Terms

Conditions

Failed Back Surgery Syndromepost laminectomy syndrome

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsBack PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Peter C. Gerszten, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2001

First Posted

July 9, 2001

Study Start

October 1, 2000

Study Completion

October 1, 2002

Last Updated

June 7, 2013

Record last verified: 2006-03

Locations

US(1)