Sciatica Clinical Trial
Official title:
Outcome of Surgery for Sciatica - a Comparison of Data From Three National Quality Registries
Verified date | August 2016 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Purpose: The incidence of surgery for lumbar disc hernia varies. According to the national
spine registries in Sweden, Norway and Denmark, there is a 30-60% difference in surgical
incidence between these countries. The cause for this difference is not known. It may reflect
a difference in incidence of lumbar disc hernia, but with a similar socio-economic and
ethnical background in these countries, it is more likely that the differences are due to
varying surgical indications. Comparing indications for surgery, patient reported outcome and
factors predictive for outcome after surgery for lumbar disc hernia in these countries could
provide information about optimal indications for surgery.
Hypotheses: (i) there are no differences in patient-reported outcome after surgery between
these countries, (ii) there are no differences in indications for surgery between these
countries and (iii), factors that predict outcome are similar in these countries.
Method of research: By using data from three Nordic national spine registers, we will compare
baseline data, indications for surgery and patient reported outcome one year after surgery
for lumbar disc herniation. Register based studies have advantages such as large sample
sizes, reflecting real life, but they also have limitations such as lower follow-up rates
than clinical trials. A non-response analysis will be performed to take this into account.
Status | Completed |
Enrollment | 7500 |
Est. completion date | June 2015 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients treated with surgery for lumbar disc herniation in Denmark, Sweden or Norway and registered in a national quality register. Exclusion Criteria: - Patients not treated with discectomy for the lumbar disc herniation. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet |
Højmark K, Støttrup C, Carreon L, Andersen MO. Patient-reported outcome measures unbiased by loss of follow-up. Single-center study based on DaneSpine, the Danish spine surgery registry. Eur Spine J. 2016 Jan;25(1):282-6. doi: 10.1007/s00586-015-4127-3. Epub 2015 Jul 25. — View Citation
Solberg TK, Sørlie A, Sjaavik K, Nygaard ØP, Ingebrigtsen T. Would loss to follow-up bias the outcome evaluation of patients operated for degenerative disorders of the lumbar spine? Acta Orthop. 2011 Feb;82(1):56-63. doi: 10.3109/17453674.2010.548024. Epub 2010 Dec 29. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oswestry disability index | Index at baseline, index change from preoperative to 1 year follow-up and actual index at 1 year follow-up. Oswestry disability index version 2.1 (from 0; no disability to 100; maximum disability) |
preoperative and 1 year postoperative | |
Secondary | Numerical rating scale for leg pain | Index at baseline, index change from preoperative to 1 year follow-up and actual index at 1 year follow-up. Numerical rating scale for leg pain (from 0; no pain to 10; maximum pain). The numerical rating scale is used in Norway. The visual analogue scale (0-100) used in Sweden and Denmark will be converted to the numerical rating scale. |
preoperative and 1 year postoperative | |
Secondary | Numerical rating scale for back pain | Index at baseline, index change from preoperative to 1 year follow-up and actual index at 1 year follow-up. Numerical rating scale for back pain (from 0; no pain to 10; maximum pain). The numerical rating scale is used in Norway. The visual analogue scale (0-100) used in Sweden and Denmark will be converted to the numerical rating scale. |
preoperative and 1 year postoperative | |
Secondary | EQ-5D | EQ-5D is a 5-item questionnaire measuring mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The answers are translated to an index representing the societal perspective of health. Index at baseline, change from preoperative to 1 year follow-up and actual index at 1 year follow-up will be presented. The EQ-5D-index is constructed using the British tariff (UK-TTO; from -0.59; worst possible health to 1; perfect health). |
preoperative and 1 year postoperative | |
Secondary | Return to work rate | The participants are asked to what extent they work preoperatively and at the 1 year follow-up. | Preoperative work rate. Work rate at the 1 year follow-up. | |
Secondary | Additional surgery in the same segment of the lumbar spine | During the 1 year follow-up |
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