Condition category
Musculoskeletal Diseases
Date applied
27/06/2010
Date assigned
31/01/2012
Last edited
14/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Lumbar back pain is extremely common, but usually gets better over time. Nevertheless, some people become seriously debilitated. It is important to find the specific pain generator responsible for these symptoms. A provocative discogram is a diagnostic test to help identify which of the disc(s) of the spine, if any, are causing pain. The aim of this study is to compare the surgical outcomes of patients operated on with or without discography before the operation.

Who can participate?
Patients aged 23 - 74 with chronic (long-term) low back pain

What does the study involve?
Participants are randomly allocated into two groups. Participants in one group undergo provocative discography to find out the main generator of the pain, and those with positive findings are sent to undergo surgical treatment. Participants in the other group do not undergo provocative discography and all undergo surgery. The surgical outcomes of the two groups are compared.

What are the possible benefits and risks of participating?
All participants undergo standard tests and after that surgical treatment which will hopefully improve their health and physical function. Discography has proven to be a relatively safe procedure. Major risks of procedure include infection, hematoma (a solid swelling of clotted blood) and nerve injury. These complications are extremely rare. The most feared complication is discitis (inflammation between the discs) which is also extremely rare.

Where is the study run from?
University of Zagreb School of Medicine and the Clinic of Traumatology Zagreb (Croatia)

When is the study starting and how long is it expected to run for?
January 2003 to December 2009

Who is funding the study?
Ministry of Health (Croatia)

Who is the main contact?
Petra Margetic
hpetra23@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marin Stancic

ORCID ID

Contact details

Clinic for Neurosurgery
KBC Zagreb
Kispaticeva 12
Zagreb
10000
Croatia
-
marin@stancic.eu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The role of provocative discography in surgical treatment for patients with chronic low back pain: a randomised controlled study

Acronym

Study hypothesis

Provocative discography is able to locate the precise disc of clinical significance and determine the exact cause of the pain

Ethics approval

1. Medical Ethics Committee of Clinic for Traumatology Zagreb, 28/11/2007
2. Medical Ethics Committee of Zagreb Medical University, 04/02/2008

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Low back pain/ischiatic pain

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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%

Secondary outcome measures

1. 36-item Short Form Health Survey (SF-36) update
2. Likert bipolar scaling method measuring either positive or negative response to a statement

Overall trial start date

01/01/2003

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

310 patients

Participant exclusion criteria

1. Tumour
2. Trauma
3. Psychiatric disease
4. Pregnancy

Recruitment start date

01/01/2003

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Croatia

Trial participating centre

KBC Zagreb
Zagreb
10000
Croatia

Sponsor information

Organisation

KBC Zagreb [Klinički bolnički centar Zagreb] (Croatia)

Sponsor details

c/o Marin Stancic
Clinic for Neurosurgery
Kispaticeva 12
Zagreb
10000
Croatia

Sponsor type

Hospital/treatment centre

Website

http://www.kbc-zagreb.hr/

Funders

Funder type

Hospital/treatment centre

Funder name

KBC Zagreb [Klinički bolnički centar Zagreb] (Croatia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

14/02/2017: Plain English summary added.