Effectiveness and cost-effectiveness of mechanical diagnosis and treatment combined with transforaminal epidural steroid injections for patients on a waiting list for surgery for a chronic lumbar herniated disc: a randomized controlled trial and economic evaluation

Elizabeth N. Mutubuki; Hans van Helvoirt; Johanna M. van Dongen; Mariska van ’t Klooster; Ângela Jornada Ben; Carmen LA. Vleggeert-Lankamp; Frank Huygen; Maurits W. van Tulder; Hanneke AHJ. Klopper-Kes; Servan Rooker; Mathieu Lenders; Niels A. van der Gaag; Carel FE Hoffmann; Paul Leliefeld P; Elmar M. Kleinjan; Marije Pol; Raymond WJG. Ostelo

doi:10.1016/j.spinee.2025.01.012

Effectiveness and cost-effectiveness of mechanical diagnosis and treatment combined with transforaminal epidural steroid injections for patients on a waiting list for surgery for a chronic lumbar herniated disc: a randomized controlled trial and economic evaluation

Elizabeth N. Mutubuki, Hans van Helvoirt, Johanna M. van Dongen, Mariska van ’t Klooster, Ângela Jornada Ben, Carmen LA. Vleggeert-Lankamp, Frank Huygen, Maurits W. van Tulder, Hanneke AHJ. Klopper-Kes, Servan Rooker, Mathieu Lenders, Niels A. van der Gaag, Carel FE Hoffmann, Paul Leliefeld P, Elmar M. Kleinjan, Marije Pol, Raymond WJG. Ostelo

Research output: Contribution to Journal › Article › Academic › peer-review

Abstract

Background Context Mechanical Diagnosis and Treatment (MDT) and epidural steroid injections have the potential to reduce pain and disability in sciatica patients and prevent surgery. However, data on their combined influence in reducing the amount of sciatica surgeries is lacking.

Purpose To assess if a combination therapy (MDT and TESIs), administered while being on the waiting list for lumbar herniated disc surgery, is effective and cost-effective compared to no intervention (i.e., usual care).

Study design Multicentre randomized controlled trial with economic evaluation and one-year follow-up.

Patient Sample Seventy-two adult patients on a waiting list for lumbar herniated disc surgery.

Outcome Measures Primary outcome was undergoing lumbar disc surgery during follow-up (yes/no). Secondary outcomes included back and leg pain intensity (NPRS), physical functioning (RMDQ-23), self-perceived recovery (GPE), and health-related quality of life (EQ-5D-5L). Total societal and total healthcare were measured.

Methods Participants were randomly assigned to combination therapy (intervention group, n=34) or no intervention (control group, n=38).

Results Twenty-nine out of 38 control group patients and 11 out of 34 intervention group patients received surgery. The adjusted odds ratio of receiving surgery in the intervention group compared to the control group was 0.09 (95%CI: 0.02 to 0.35) and the adjusted risk ratio 0.29 (95%CI: 0.08 to 0.69). There were no differences in clinical effects between both groups. Surgical, total societal, and total healthcare costs were on average €1,969, €1,754, and €2,363 lower in the intervention group, respectively. The combination therapy's probability of being cost-effective was moderate (≤0.66) across a range of willingness-to-pay values from €20,000/QALY to €80,000/QALY, from a societal perspective.

Conclusion Patients on the waiting list for lumbar disc surgery and who are open to postpone surgery, may benefit from the combination therapy intervention.

Original language	English
Pages (from-to)	1309-1321
Number of pages	13
Journal	The Spine Journal
Volume	25
Issue number	7
Early online date	31 Jan 2025
DOIs	https://doi.org/10.1016/j.spinee.2025.01.012
Publication status	Published - Jul 2025

Funding

ZorgOnderzoek Nederlands Medische Wetenschappen (ZonMw) & Rugpoli funded the PLUS-study. Author disclosures: ENM: Nothing to disclose. HVH: Nothing to disclose. JMVD: Nothing to disclose. MVK: Nothing to disclose. AJB: Nothing to disclose. CVL: Scientific Advisory Board/Other Office: Rijndam Rehabilitation Centre Advisory Board, Excom Eurospine, Board CSRS Europe, President Netherlands Association for Neurosurgery, unpaid (none); Grants: Thromboembolic complications in Neurosurgery (Covidien), Fundamentals of radiculopathy (YM Fund/Achmea health insurance and Eurospine), Stop Smoking (Achmea), 5yr FU disc prosthesis in cervical spine surgery (CSRS E). faculty for EANS, CSRS, Eurospine (none). FH: Consulting: Boston Scientific (None); Speaking and/or Teaching Arrangements: ABBOTT Grunenthal (None). MWVT: Grant: ZonMw (F). HAKK: Nothing to disclose. SR: Nothing to disclose. ML: Nothing to disclose. NAVDG: Nothing to disclose. CFEH: Nothing to disclose. PLP: Nothing to disclose. EMK: Nothing to disclose. MP: Nothing to disclose. RWJGO: Grant: ZonMW (F); ZonMW (G); DBRIC (D); NVMT (F); DBRIC (F); ZonMW (F).

Funders	Funder number
YM Fund
ZorgOnderzoek Nederlands Medische Wetenschappen
Centre for Studies in Religion and Society, University of Victoria
Rijndam Rehabilitation Centre Advisory Board
NVMT
ZonMw
Covidien
Achmea health insurance and Eurospine
DBRIC
Netherlands Association for Neurosurgery
Fundamentals of radiculopathy

Keywords

Effectiveness
Cost-effectiveness
Lumbar Disc Herniation
Lumbar Disc surgery
Mechanical Diagnosis Therapy
Steroid Injections

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Mutubuki, E. N., van Helvoirt, H., van Dongen, J. M., van ’t Klooster, M., Jornada Ben, Â., Vleggeert-Lankamp, C. LA., Huygen, F., van Tulder, M. W., Klopper-Kes, H. AHJ., Rooker, S., Lenders, M., van der Gaag, N. A., Hoffmann, C. FE., P, P. L., Kleinjan, E. M., Pol, M., & Ostelo, R. WJG. (2025). Effectiveness and cost-effectiveness of mechanical diagnosis and treatment combined with transforaminal epidural steroid injections for patients on a waiting list for surgery for a chronic lumbar herniated disc: a randomized controlled trial and economic evaluation. The Spine Journal, 25(7), 1309-1321. https://doi.org/10.1016/j.spinee.2025.01.012

Mutubuki, Elizabeth N. ; van Helvoirt, Hans ; van Dongen, Johanna M. et al. / Effectiveness and cost-effectiveness of mechanical diagnosis and treatment combined with transforaminal epidural steroid injections for patients on a waiting list for surgery for a chronic lumbar herniated disc: a randomized controlled trial and economic evaluation. In: The Spine Journal. 2025 ; Vol. 25, No. 7. pp. 1309-1321.

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title = "Effectiveness and cost-effectiveness of mechanical diagnosis and treatment combined with transforaminal epidural steroid injections for patients on a waiting list for surgery for a chronic lumbar herniated disc: a randomized controlled trial and economic evaluation",

abstract = "Background Context Mechanical Diagnosis and Treatment (MDT) and epidural steroid injections have the potential to reduce pain and disability in sciatica patients and prevent surgery. However, data on their combined influence in reducing the amount of sciatica surgeries is lacking. Purpose To assess if a combination therapy (MDT and TESIs), administered while being on the waiting list for lumbar herniated disc surgery, is effective and cost-effective compared to no intervention (i.e., usual care). Study design Multicentre randomized controlled trial with economic evaluation and one-year follow-up. Patient Sample Seventy-two adult patients on a waiting list for lumbar herniated disc surgery. Outcome Measures Primary outcome was undergoing lumbar disc surgery during follow-up (yes/no). Secondary outcomes included back and leg pain intensity (NPRS), physical functioning (RMDQ-23), self-perceived recovery (GPE), and health-related quality of life (EQ-5D-5L). Total societal and total healthcare were measured. Methods Participants were randomly assigned to combination therapy (intervention group, n=34) or no intervention (control group, n=38). Results Twenty-nine out of 38 control group patients and 11 out of 34 intervention group patients received surgery. The adjusted odds ratio of receiving surgery in the intervention group compared to the control group was 0.09 (95\%CI: 0.02 to 0.35) and the adjusted risk ratio 0.29 (95\%CI: 0.08 to 0.69). There were no differences in clinical effects between both groups. Surgical, total societal, and total healthcare costs were on average €1,969, €1,754, and €2,363 lower in the intervention group, respectively. The combination therapy's probability of being cost-effective was moderate (≤0.66) across a range of willingness-to-pay values from €20,000/QALY to €80,000/QALY, from a societal perspective. Conclusion Patients on the waiting list for lumbar disc surgery and who are open to postpone surgery, may benefit from the combination therapy intervention.",

keywords = "Effectiveness, Cost-effectiveness, Lumbar Disc Herniation, Lumbar Disc surgery, Mechanical Diagnosis Therapy, Steroid Injections",

author = "Mutubuki, \{Elizabeth N.\} and \{van Helvoirt\}, Hans and \{van Dongen\}, \{Johanna M.\} and \{van {\textquoteright}t Klooster\}, Mariska and \{Jornada Ben\}, {\^A}ngela and Vleggeert-Lankamp, \{Carmen LA.\} and Frank Huygen and \{van Tulder\}, \{Maurits W.\} and Klopper-Kes, \{Hanneke AHJ.\} and Servan Rooker and Mathieu Lenders and \{van der Gaag\}, \{Niels A.\} and Hoffmann, \{Carel FE\} and P, \{Paul Leliefeld\} and Kleinjan, \{Elmar M.\} and Marije Pol and Ostelo, \{Raymond WJG.\}",

year = "2025",

month = jul,

doi = "10.1016/j.spinee.2025.01.012",

language = "English",

volume = "25",

pages = "1309--1321",

journal = "The Spine Journal",

issn = "1529-9430",

publisher = "Elsevier Inc.",

number = "7",

}

Mutubuki, EN, van Helvoirt, H, van Dongen, JM, van ’t Klooster, M, Jornada Ben, Â, Vleggeert-Lankamp, CLA, Huygen, F, van Tulder, MW, Klopper-Kes, HAHJ, Rooker, S, Lenders, M, van der Gaag, NA, Hoffmann, CFE, P, PL, Kleinjan, EM, Pol, M & Ostelo, RWJG 2025, 'Effectiveness and cost-effectiveness of mechanical diagnosis and treatment combined with transforaminal epidural steroid injections for patients on a waiting list for surgery for a chronic lumbar herniated disc: a randomized controlled trial and economic evaluation', The Spine Journal, vol. 25, no. 7, pp. 1309-1321. https://doi.org/10.1016/j.spinee.2025.01.012

Effectiveness and cost-effectiveness of mechanical diagnosis and treatment combined with transforaminal epidural steroid injections for patients on a waiting list for surgery for a chronic lumbar herniated disc: a randomized controlled trial and economic evaluation. / Mutubuki, Elizabeth N.; van Helvoirt, Hans; van Dongen, Johanna M. et al.
In: The Spine Journal, Vol. 25, No. 7, 07.2025, p. 1309-1321.

Research output: Contribution to Journal › Article › Academic › peer-review

TY - JOUR

T1 - Effectiveness and cost-effectiveness of mechanical diagnosis and treatment combined with transforaminal epidural steroid injections for patients on a waiting list for surgery for a chronic lumbar herniated disc: a randomized controlled trial and economic evaluation

AU - Mutubuki, Elizabeth N.

AU - van Helvoirt, Hans

AU - van Dongen, Johanna M.

AU - van ’t Klooster, Mariska

AU - Jornada Ben, Ângela

AU - Vleggeert-Lankamp, Carmen LA.

AU - Huygen, Frank

AU - van Tulder, Maurits W.

AU - Klopper-Kes, Hanneke AHJ.

AU - Rooker, Servan

AU - Lenders, Mathieu

AU - van der Gaag, Niels A.

AU - Hoffmann, Carel FE

AU - P, Paul Leliefeld

AU - Kleinjan, Elmar M.

AU - Pol, Marije

AU - Ostelo, Raymond WJG.

PY - 2025/7

Y1 - 2025/7

N2 - Background Context Mechanical Diagnosis and Treatment (MDT) and epidural steroid injections have the potential to reduce pain and disability in sciatica patients and prevent surgery. However, data on their combined influence in reducing the amount of sciatica surgeries is lacking. Purpose To assess if a combination therapy (MDT and TESIs), administered while being on the waiting list for lumbar herniated disc surgery, is effective and cost-effective compared to no intervention (i.e., usual care). Study design Multicentre randomized controlled trial with economic evaluation and one-year follow-up. Patient Sample Seventy-two adult patients on a waiting list for lumbar herniated disc surgery. Outcome Measures Primary outcome was undergoing lumbar disc surgery during follow-up (yes/no). Secondary outcomes included back and leg pain intensity (NPRS), physical functioning (RMDQ-23), self-perceived recovery (GPE), and health-related quality of life (EQ-5D-5L). Total societal and total healthcare were measured. Methods Participants were randomly assigned to combination therapy (intervention group, n=34) or no intervention (control group, n=38). Results Twenty-nine out of 38 control group patients and 11 out of 34 intervention group patients received surgery. The adjusted odds ratio of receiving surgery in the intervention group compared to the control group was 0.09 (95%CI: 0.02 to 0.35) and the adjusted risk ratio 0.29 (95%CI: 0.08 to 0.69). There were no differences in clinical effects between both groups. Surgical, total societal, and total healthcare costs were on average €1,969, €1,754, and €2,363 lower in the intervention group, respectively. The combination therapy's probability of being cost-effective was moderate (≤0.66) across a range of willingness-to-pay values from €20,000/QALY to €80,000/QALY, from a societal perspective. Conclusion Patients on the waiting list for lumbar disc surgery and who are open to postpone surgery, may benefit from the combination therapy intervention.

AB - Background Context Mechanical Diagnosis and Treatment (MDT) and epidural steroid injections have the potential to reduce pain and disability in sciatica patients and prevent surgery. However, data on their combined influence in reducing the amount of sciatica surgeries is lacking. Purpose To assess if a combination therapy (MDT and TESIs), administered while being on the waiting list for lumbar herniated disc surgery, is effective and cost-effective compared to no intervention (i.e., usual care). Study design Multicentre randomized controlled trial with economic evaluation and one-year follow-up. Patient Sample Seventy-two adult patients on a waiting list for lumbar herniated disc surgery. Outcome Measures Primary outcome was undergoing lumbar disc surgery during follow-up (yes/no). Secondary outcomes included back and leg pain intensity (NPRS), physical functioning (RMDQ-23), self-perceived recovery (GPE), and health-related quality of life (EQ-5D-5L). Total societal and total healthcare were measured. Methods Participants were randomly assigned to combination therapy (intervention group, n=34) or no intervention (control group, n=38). Results Twenty-nine out of 38 control group patients and 11 out of 34 intervention group patients received surgery. The adjusted odds ratio of receiving surgery in the intervention group compared to the control group was 0.09 (95%CI: 0.02 to 0.35) and the adjusted risk ratio 0.29 (95%CI: 0.08 to 0.69). There were no differences in clinical effects between both groups. Surgical, total societal, and total healthcare costs were on average €1,969, €1,754, and €2,363 lower in the intervention group, respectively. The combination therapy's probability of being cost-effective was moderate (≤0.66) across a range of willingness-to-pay values from €20,000/QALY to €80,000/QALY, from a societal perspective. Conclusion Patients on the waiting list for lumbar disc surgery and who are open to postpone surgery, may benefit from the combination therapy intervention.

KW - Effectiveness

KW - Cost-effectiveness

KW - Lumbar Disc Herniation

KW - Lumbar Disc surgery

KW - Mechanical Diagnosis Therapy

KW - Steroid Injections

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UR - https://www.scopus.com/inward/citedby.url?scp=85218999836&partnerID=8YFLogxK

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DO - 10.1016/j.spinee.2025.01.012

M3 - Article

C2 - 39894273

SN - 1529-9430

VL - 25

SP - 1309

EP - 1321

JO - The Spine Journal

JF - The Spine Journal

IS - 7

ER -

Mutubuki EN, van Helvoirt H, van Dongen JM, van ’t Klooster M, Jornada Ben Â, Vleggeert-Lankamp CLA et al. Effectiveness and cost-effectiveness of mechanical diagnosis and treatment combined with transforaminal epidural steroid injections for patients on a waiting list for surgery for a chronic lumbar herniated disc: a randomized controlled trial and economic evaluation. The Spine Journal. 2025 Jul;25(7):1309-1321. Epub 2025 Jan 31. doi: 10.1016/j.spinee.2025.01.012

Effectiveness and cost-effectiveness of mechanical diagnosis and treatment combined with transforaminal epidural steroid injections for patients on a waiting list for surgery for a chronic lumbar herniated disc: a randomized controlled trial and economic evaluation

Abstract

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