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A pilot study for effectiveness of non-pharmacological versus pharmacological treatment strategies for lumbar disc herniation: a pragmatic randomized controlled trial
Kim D, Kim E-S, Lee YJ, Lee JY, Park KS, Jung SY, Yang C, Han C-H, Ha I-H
Journal of Pain Research 2023 Sep 18;16:3197-3216
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

PURPOSE: We aimed to compare the efficacy, safety, and cost-effectiveness of non-pharmacological- and pharmacological treatment strategies for Lumbar disc herniation (LDH) in pragmatic clinical settings. Patients and METHODS: This study was a pilot, two-armed, parallel pragmatic randomized controlled trial. Thirty patients aged 19 to 70 years with a numeric rating scale (NRS) score >= 5 for sciatica and confirmed LDH on magnetic resonance imaging (MRI) were included. Participants were assigned in a 1 to 1 ratio to non-pharmacological (non-Phm) or pharmacological (Phm) treatment group. They were treated for 8 weeks and a total follow-up period was 26 weeks after randomization. Non-Phm treatment included acupuncture, spinal manual therapy, etc., Phm included medication, injection, nerve block, etc., The primary outcome was a numeric rating scale (NRS) of radiating leg pain. NRS for low back pain, Oswestry disability index, visual analog scale, Fear-Avoidance Beliefs Questionnaire, patient global impression of change, Short Form-12 Health Survey, version 2, 5-level European Quality of Life-5 dimensions (EQ-5D) were also measured. Linear mixed model was used to evaluated the difference in change of outcomes from baseline between two groups. An economic evaluation was conducted using incremental cost-effectiveness ratios. RESULTS: There was no significant difference between the two groups in the intervention period, but non-Phm group showed significantly greater degree of improvement in follow-up of Week 14. Difference in the NRS for sciatica and ODI were 1.65 (95% CI 0.59 to 2.71, p = 0.003) and 8.67 (95% CI 1.37 to 15.98, p = 0.21), respectively in Week 14. The quality-adjusted life year (QALY) value calculated by EQ-5D and Short Form-6 Dimension were 0.006 (95% CI -0.012 to 0.024, p = 0.472) and 0.015 (95% CI -0.008 to 0.038, p = 0.195) higher in non-Phm group than in Phm group. The cost was lower in non-Phm group than in Phm group (difference -682, 95% CI -3349 to 1699, p = 0.563). CONCLUSION: We confirmed that the non-Phm treatment could be more cost-effective treatments than Phm treatments and feasibility of a large-scale of main study in future.

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