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 (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.

Keywords: Cost-effectiveness; Effectiveness; Lumbar disc herniation; Lumbar disc surgery; Mechanical diagnosis therapy; Steroid injections.