A Pilot Study for Effectiveness of Non-Pharmacological versus Pharmacological Treatment Strategies for Lumbar Disc Herniation: A Pragmatic Randomized Controlled Trial

Abstract

Doori Kim,1 Eun-San Kim,1 Yoon Jae Lee,1 Jee Young Lee,2 Kyong Sun Park,3 So Young Jung,4 Changsop Yang,5 Chang-Hyun Han,6,7 In-Hyuk Ha1 1Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, 06110, Republic of Korea; 2Department of Korean Internal Medicine, Integrative Cancer Center, Cha Ilsan Medical Center, Goyang-si, Gyeonggi-do, Republic of Korea; 3Jaseng Hospital of Korean Medicine, Seoul, 06110, Republic of Korea; 4Clinical Research Coordinating Team, Korea Institute of Oriental Medicine, Daejeon, 34054, Republic of Korea; 5Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea; 6Korean Convergence Medical Science, University of Science & Technology (UST), School of Korea Institute of Oriental Medicine, Daejeon, 34054, Republic of Korea; 7KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, 34054, Republic of KoreaCorrespondence: In-Hyuk Ha, Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 540 Gangnam-daero, Gangnam-gu, Seoul, 06110, Republic of Korea, Tel [phone], Fax [phone], Email [email protected] Chang-Hyun Han, KM Science Research Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea, Tel [phone], Fax [phone], Email [email protected]: 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– 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 1:1 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.Keywords: conservative treatment, intervertebral disc displacement, low back pain, sciatica

Keywords

• conservative treatment
• intervertebral disc displacement
• low back pain
• sciatica;