Microdiscectomy compared with transforaminal epidural steroid injection for persistent radicular pain caused by prolapsed intervertebral disc: the NERVES RCT
Background: Sciatica is a common condition reported to affect > 3% of the UK population at any time and is most often caused by a prolapsed intervertebral disc. Currently, there is no uniformly adopted treatment strategy. Invasive treatments, such as surgery (i.e. microdiscectomy) and transforami...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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NIHR Journals Library
2021-04-01
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| Series: | Health Technology Assessment |
| Subjects: | |
| Online Access: | https://doi.org/10.3310/hta25240 |
| _version_ | 1818951034955890688 |
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| author | Martin J Wilby Ashley Best Eifiona Wood Girvan Burnside Emma Bedson Hannah Short Dianne Wheatley Daniel Hill-McManus Manohar Sharma Simon Clark Jennifer Bostock Sally Hay Ganesan Baranidharan Cathy Price Richard Mannion Peter J Hutchinson Dyfrig A Hughes Anthony Marson Paula R Williamson |
| author_facet | Martin J Wilby Ashley Best Eifiona Wood Girvan Burnside Emma Bedson Hannah Short Dianne Wheatley Daniel Hill-McManus Manohar Sharma Simon Clark Jennifer Bostock Sally Hay Ganesan Baranidharan Cathy Price Richard Mannion Peter J Hutchinson Dyfrig A Hughes Anthony Marson Paula R Williamson |
| author_sort | Martin J Wilby |
| collection | DOAJ |
| description | Background: Sciatica is a common condition reported to affect > 3% of the UK population at any time and is most often caused by a prolapsed intervertebral disc. Currently, there is no uniformly adopted treatment strategy. Invasive treatments, such as surgery (i.e. microdiscectomy) and transforaminal epidural steroid injection, are often reserved for failed conservative treatment. Objective: To compare the clinical effectiveness and cost-effectiveness of microdiscectomy with transforaminal epidural steroid injection for the management of radicular pain secondary to lumbar prolapsed intervertebral disc for non-emergency presentation of sciatica of < 12 months’ duration. Interventions: Patients were randomised to either (1) microdiscectomy or (2) transforaminal epidural steroid injection. Design: A pragmatic, multicentre, randomised prospective trial comparing microdiscectomy with transforaminal epidural steroid injection for sciatica due to prolapsed intervertebral disc with < 1 year symptom duration. Setting: NHS services providing secondary spinal surgical care within the UK. Participants: A total of 163 participants (aged 16–65 years) were recruited from 11 UK NHS outpatient clinics. Main outcome measures: The primary outcome was participant-completed Oswestry Disability Questionnaire score at 18 weeks post randomisation. Secondary outcomes were visual analogue scores for leg pain and back pain; modified Roland–Morris score (for sciatica), Core Outcome Measures Index score and participant satisfaction at 12-weekly intervals. Cost-effectiveness and quality of life were assessed using the EuroQol-5 Dimensions, five-level version; Hospital Episode Statistics data; medication usage; and self-reported cost data at 12-weekly intervals. Adverse event data were collected. The economic outcome was incremental cost per quality-adjusted life-year gained from the perspective of the NHS in England. Results: Eighty-three participants were allocated to transforaminal epidural steroid injection and 80 participants were allocated to microdiscectomy, using an online randomisation system. At week 18, Oswestry Disability Questionnaire scores had decreased, relative to baseline, by 26.7 points in the microdiscectomy group and by 24.5 points in the transforaminal epidural steroid injection. The difference between the treatments was not statistically significant (estimated treatment effect –4.25 points, 95% confidence interval –11.09 to 2.59 points). Nor were there significant differences between treatments in any of the secondary outcomes: Oswestry Disability Questionnaire scores, visual analogue scores for leg pain and back pain, modified Roland–Morris score and Core Outcome Measures Index score up to 54 weeks. There were four (3.8%) serious adverse events in the microdiscectomy group, including one nerve palsy (foot drop), and none in the transforaminal epidural steroid injection group. Compared with transforaminal epidural steroid injection, microdiscectomy had an incremental cost-effectiveness ratio of £38,737 per quality-adjusted life-year gained and a probability of 0.17 of being cost-effective at a willingness to pay threshold of £20,000 per quality-adjusted life-year. Limitations: Primary outcome data was invalid or incomplete for 24% of participants. Sensitivity analyses demonstrated robustness to assumptions made regarding missing data. Eighteen per cent of participants in the transforaminal epidural steroid injection group subsequently received microdiscectomy prior to their primary outcome assessment. Conclusions: To the best of our knowledge, the NErve Root Block VErsus Surgery trial is the first trial to evaluate the comparative clinical effectiveness and cost-effectiveness of microdiscectomy and transforaminal epidural steroid injection. No statistically significant difference was found between the two treatments for the primary outcome. It is unlikely that microdiscectomy is cost-effective compared with transforaminal epidural steroid injection at a threshold of £20,000 per quality-adjusted life-year for sciatica secondary to prolapsed intervertebral disc. Future work: These results will lead to further studies in the streamlining and earlier management of discogenic sciatica. Trial registration: Current Controlled Trials ISRCTN04820368 and EudraCT 2014-002751-25. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 24. See the NIHR Journals Library website for further project information. |
| first_indexed | 2024-12-20T09:28:04Z |
| format | Article |
| id | doaj.art-822c34010724485e9bf788140139f60f |
| institution | Directory Open Access Journal |
| issn | 1366-5278 2046-4924 |
| language | English |
| last_indexed | 2024-12-20T09:28:04Z |
| publishDate | 2021-04-01 |
| publisher | NIHR Journals Library |
| record_format | Article |
| series | Health Technology Assessment |
| spelling | doaj.art-822c34010724485e9bf788140139f60f2022-12-21T19:45:08ZengNIHR Journals LibraryHealth Technology Assessment1366-52782046-49242021-04-01252410.3310/hta2524012/201/10Microdiscectomy compared with transforaminal epidural steroid injection for persistent radicular pain caused by prolapsed intervertebral disc: the NERVES RCTMartin J Wilby0Ashley Best1Eifiona Wood2Girvan Burnside3Emma Bedson4Hannah Short5Dianne Wheatley6Daniel Hill-McManus7Manohar Sharma8Simon Clark9Jennifer Bostock10Sally Hay11Ganesan Baranidharan12Cathy Price13Richard Mannion14Peter J Hutchinson15Dyfrig A Hughes16Anthony Marson17Paula R Williamson18Department of Neurosurgery, The Walton Centre NHS Foundation Trust (member of Liverpool Health Partners), Liverpool, UKLiverpool Clinical Trials Centre, University of Liverpool (member of Liverpool Health Partners), Liverpool, UKCentre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UKLiverpool Clinical Trials Centre, University of Liverpool (member of Liverpool Health Partners), Liverpool, UKLiverpool Clinical Trials Centre, University of Liverpool (member of Liverpool Health Partners), Liverpool, UKLiverpool Clinical Trials Centre, University of Liverpool (member of Liverpool Health Partners), Liverpool, UKLiverpool Clinical Trials Centre, University of Liverpool (member of Liverpool Health Partners), Liverpool, UKCentre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UKDepartment of Pain Medicine, The Walton Centre NHS Foundation Trust, Liverpool, Liverpool, UKDepartment of Neurosurgery, The Walton Centre NHS Foundation Trust (member of Liverpool Health Partners), Liverpool, UKPatient and public involvement representative, Kent, UKPatient and public involvement representative, Norfolk, UKLeeds Teaching Hospital NHS Trust, Leeds General Infirmary, Leeds, UKPain Clinic, Solent NHS Trust, Southampton, UKCambridge University Hospitals NHS Trust, Cambridge, UKAcademic Division of Neurosurgery, University of Cambridge, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UKCentre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UKDepartment of Pharmacology and Therapeutics, University of Liverpool and The Walton Centre NHS Foundation Trust, Liverpool, UKLiverpool Clinical Trials Centre, University of Liverpool (member of Liverpool Health Partners), Liverpool, UKBackground: Sciatica is a common condition reported to affect > 3% of the UK population at any time and is most often caused by a prolapsed intervertebral disc. Currently, there is no uniformly adopted treatment strategy. Invasive treatments, such as surgery (i.e. microdiscectomy) and transforaminal epidural steroid injection, are often reserved for failed conservative treatment. Objective: To compare the clinical effectiveness and cost-effectiveness of microdiscectomy with transforaminal epidural steroid injection for the management of radicular pain secondary to lumbar prolapsed intervertebral disc for non-emergency presentation of sciatica of < 12 months’ duration. Interventions: Patients were randomised to either (1) microdiscectomy or (2) transforaminal epidural steroid injection. Design: A pragmatic, multicentre, randomised prospective trial comparing microdiscectomy with transforaminal epidural steroid injection for sciatica due to prolapsed intervertebral disc with < 1 year symptom duration. Setting: NHS services providing secondary spinal surgical care within the UK. Participants: A total of 163 participants (aged 16–65 years) were recruited from 11 UK NHS outpatient clinics. Main outcome measures: The primary outcome was participant-completed Oswestry Disability Questionnaire score at 18 weeks post randomisation. Secondary outcomes were visual analogue scores for leg pain and back pain; modified Roland–Morris score (for sciatica), Core Outcome Measures Index score and participant satisfaction at 12-weekly intervals. Cost-effectiveness and quality of life were assessed using the EuroQol-5 Dimensions, five-level version; Hospital Episode Statistics data; medication usage; and self-reported cost data at 12-weekly intervals. Adverse event data were collected. The economic outcome was incremental cost per quality-adjusted life-year gained from the perspective of the NHS in England. Results: Eighty-three participants were allocated to transforaminal epidural steroid injection and 80 participants were allocated to microdiscectomy, using an online randomisation system. At week 18, Oswestry Disability Questionnaire scores had decreased, relative to baseline, by 26.7 points in the microdiscectomy group and by 24.5 points in the transforaminal epidural steroid injection. The difference between the treatments was not statistically significant (estimated treatment effect –4.25 points, 95% confidence interval –11.09 to 2.59 points). Nor were there significant differences between treatments in any of the secondary outcomes: Oswestry Disability Questionnaire scores, visual analogue scores for leg pain and back pain, modified Roland–Morris score and Core Outcome Measures Index score up to 54 weeks. There were four (3.8%) serious adverse events in the microdiscectomy group, including one nerve palsy (foot drop), and none in the transforaminal epidural steroid injection group. Compared with transforaminal epidural steroid injection, microdiscectomy had an incremental cost-effectiveness ratio of £38,737 per quality-adjusted life-year gained and a probability of 0.17 of being cost-effective at a willingness to pay threshold of £20,000 per quality-adjusted life-year. Limitations: Primary outcome data was invalid or incomplete for 24% of participants. Sensitivity analyses demonstrated robustness to assumptions made regarding missing data. Eighteen per cent of participants in the transforaminal epidural steroid injection group subsequently received microdiscectomy prior to their primary outcome assessment. Conclusions: To the best of our knowledge, the NErve Root Block VErsus Surgery trial is the first trial to evaluate the comparative clinical effectiveness and cost-effectiveness of microdiscectomy and transforaminal epidural steroid injection. No statistically significant difference was found between the two treatments for the primary outcome. It is unlikely that microdiscectomy is cost-effective compared with transforaminal epidural steroid injection at a threshold of £20,000 per quality-adjusted life-year for sciatica secondary to prolapsed intervertebral disc. Future work: These results will lead to further studies in the streamlining and earlier management of discogenic sciatica. Trial registration: Current Controlled Trials ISRCTN04820368 and EudraCT 2014-002751-25. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 24. See the NIHR Journals Library website for further project information.https://doi.org/10.3310/hta25240sciaticaprolapsed discprolapsed intervertebral discinjectiontransforaminal epidural steroid injectionmicrodiscectomysurgeryclinical trialrandomisedcost-effectiveness analysishealth technology assessment |
| spellingShingle | Martin J Wilby Ashley Best Eifiona Wood Girvan Burnside Emma Bedson Hannah Short Dianne Wheatley Daniel Hill-McManus Manohar Sharma Simon Clark Jennifer Bostock Sally Hay Ganesan Baranidharan Cathy Price Richard Mannion Peter J Hutchinson Dyfrig A Hughes Anthony Marson Paula R Williamson Microdiscectomy compared with transforaminal epidural steroid injection for persistent radicular pain caused by prolapsed intervertebral disc: the NERVES RCT Health Technology Assessment sciatica prolapsed disc prolapsed intervertebral disc injection transforaminal epidural steroid injection microdiscectomy surgery clinical trial randomised cost-effectiveness analysis health technology assessment |
| title | Microdiscectomy compared with transforaminal epidural steroid injection for persistent radicular pain caused by prolapsed intervertebral disc: the NERVES RCT |
| title_full | Microdiscectomy compared with transforaminal epidural steroid injection for persistent radicular pain caused by prolapsed intervertebral disc: the NERVES RCT |
| title_fullStr | Microdiscectomy compared with transforaminal epidural steroid injection for persistent radicular pain caused by prolapsed intervertebral disc: the NERVES RCT |
| title_full_unstemmed | Microdiscectomy compared with transforaminal epidural steroid injection for persistent radicular pain caused by prolapsed intervertebral disc: the NERVES RCT |
| title_short | Microdiscectomy compared with transforaminal epidural steroid injection for persistent radicular pain caused by prolapsed intervertebral disc: the NERVES RCT |
| title_sort | microdiscectomy compared with transforaminal epidural steroid injection for persistent radicular pain caused by prolapsed intervertebral disc the nerves rct |
| topic | sciatica prolapsed disc prolapsed intervertebral disc injection transforaminal epidural steroid injection microdiscectomy surgery clinical trial randomised cost-effectiveness analysis health technology assessment |
| url | https://doi.org/10.3310/hta25240 |
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