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ISRCTN
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ISRCTN51240362
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ClinicalTrials.gov identifier
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Public title
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The role of provocative discography in surgical treatment for patients with chronic low back pain
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Scientific title
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The role of provocative discography in surgical treatment for patients with chronic low back pain: a randomised controlled study
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Provocative discography is able to locate the precise disc of clinical significance and determine the exact cause of the pain
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Lay summary
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Lay summary under review 2
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Ethics approval
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1. Medical Ethics Committee of Clinic for Traumatology Zagreb, 28 November 2007
2. Medical Ethics Committee of Zagreb Medical University, 04 February 2008
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Study design
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Randomised controlled trial
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Countries of recruitment
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Croatia
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Disease/condition/study domain
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Low back pain / ischiatic pain
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Participants - inclusion criteria
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1. Aged 23 - 74 years, either sex
2. Chronic low back pain and ischiatic pain
3. Radiological findings describe more than one cause of the pain
4. Uncertain clinical status after complete diagnostic imaging
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Participants - exclusion criteria
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1. Tumour
2. Trauma
3. Psychiatric disease
4. Pregnancy
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Anticipated start date
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01/01/2003
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Anticipated end date
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31/12/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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310 patients
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Interventions
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At first all 310 patients were randomized into a trial group with 207 patients and a control group with 103 patients.
Patients in trial group filled in the Oswestry, Zung and MSPQ test, if the results did not show high depression values (Zung results more than 33) and somatisation (MSPQ results more than 12 in patients with Zung results between 18 and 33) we considered the patients adequate to be sent to provocative discography.
Patients with positive findings on provocative discography were sent to surgical treatment. Surgery was performed on patients in trial group with positive finding on discography and also on all patients in control group without discography.
All patients, in both groups were categorized by Thalgott. In cases categorized as C and/or D changes on more segments (mostly two) we performed transpedicular fixation. In cases categorized E and F group by Thalgott we performed circumferential – posterolateral and intercorporal fixation.
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Primary outcome measure(s)
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1. Statistically significant difference between two pre-operative groups should be 4 points or 8%
2. Statistically significant difference between pre-operative and post-operative groups should be 10 points or 20%.
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Secondary outcome measure(s)
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1. 36-item Short Form Health Survey (SF-36) update
2. Likert bipolar scaling method measuring either positive or negative response to a statement
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Sources of funding
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KBC Zagreb [Klinički bolnički centar Zagreb] (Croatia)
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Trial website
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Publications
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Contact name
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Prof
Marin
Stancic
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Address
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Clinic for Neurosurgery
KBC Zagreb
Kispaticeva 12
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City/town
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Zagreb
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Zip/Postcode
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10000
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Country
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Croatia
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Email
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marin@stancic.eu
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Sponsor
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KBC Zagreb [Klinički bolnički centar Zagreb] (Croatia)
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Address
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c/o Marin Stancic
Clinic for Neurosurgery
Kispaticeva 12
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City/town
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Zagreb
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Zip/Postcode
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10000
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Country
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Croatia
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Sponsor website:
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http://www.kbc-zagreb.hr/
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Date applied
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27/06/2010
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Last edited
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31/01/2012
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Date ISRCTN assigned
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31/01/2012
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