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
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引用次数: 0
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 (ie, usual care).
Study design: Multicentre randomized controlled trial with economic evaluation and 1-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, 0.02-0.35) and the adjusted risk ratio 0.29 (95% CI, 0.08-0.69). 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.
期刊介绍:
The Spine Journal, the official journal of the North American Spine Society, is an international and multidisciplinary journal that publishes original, peer-reviewed articles on research and treatment related to the spine and spine care, including basic science and clinical investigations. It is a condition of publication that manuscripts submitted to The Spine Journal have not been published, and will not be simultaneously submitted or published elsewhere. The Spine Journal also publishes major reviews of specific topics by acknowledged authorities, technical notes, teaching editorials, and other special features, Letters to the Editor-in-Chief are encouraged.