The role of provocative discography in surgical treatment for patients with chronic low back pain
| ISRCTN | ISRCTN51240362 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51240362 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/06/2010
- Registration date
- 31/01/2012
- Last edited
- 14/02/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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
Contact information
Scientific
Clinic for Neurosurgery
KBC Zagreb
Kispaticeva 12
Zagreb
10000
Croatia
| marin@stancic.eu |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The role of provocative discography in surgical treatment for patients with chronic low back pain: a randomised controlled study |
| Study hypothesis | Provocative discography is able to locate the precise disc of clinical significance and determine the exact cause of the pain |
| Ethics approval(s) | 1. Medical Ethics Committee of Clinic for Traumatology Zagreb, 28/11/2007 2. Medical Ethics Committee of Zagreb Medical University, 04/02/2008 |
| 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 |
| Primary outcome measure | 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 study start date | 01/01/2003 |
| Overall study end date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 310 patients |
| 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 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
Study participating centre
10000
Croatia
Sponsor information
Hospital/treatment centre
c/o Marin Stancic
Clinic for Neurosurgery
Kispaticeva 12
Zagreb
10000
Croatia
| Website | http://www.kbc-zagreb.hr/ |
|---|---|
"ROR" |
https://ror.org/00r9vb833 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
14/02/2017: Plain English summary added.
