RESUMO
BACKGROUND AND PURPOSE: This parallel, single-center, pragmatic, randomized controlled study aimed to investigate the effectiveness and safety of motion style acupuncture treatment (MSAT; a combination of acupuncture and Doin therapy) to reduce pain and improve the functional disability of patients with acute low back pain (aLBP) due to road traffic accidents. MATERIALS AND METHODS: Ninety-six patients with aLBP admitted to the Haeundae Jaseng Hospital of Korean Medicine in South Korea due to traffic accidents were treated with integrative Korean medicine (IKM) with additional 3-day MSAT sessions during hospitalization (MSAT group, 48 patients) or without (control group, 48 patients), and followed up for 90 days. RESULTS: The mean numeric rating scale (NRS) scores of low back pain (LBP) of the MSAT and control groups were both 6.7 (95% confidence interval [CI]: 6.3, 7.1) at baseline. After completing the third round of all applicable treatment sessions (the primary endpoint in this study), the mean NRS scores of the MSAT and control groups were 3.76 (95% CI: 3.54, 3.99) and 5.32 (95% CI: 5.09, 5.55), respectively. The difference in the mean NRS score between the two groups was 1.56 (95% CI: 1.25, 1.87). CONCLUSION: IKM treatment combined with MSAT can reduce pain and improve the range of motion of patients with aLBP. TRIAL REGISTRATION: This trial is registered at ClinicalTrial.gov (NCT04956458).
Assuntos
Terapia por Acupuntura , Dor Lombar , Humanos , Dor Lombar/terapia , Masculino , Feminino , Terapia por Acupuntura/métodos , Pessoa de Meia-Idade , Adulto , República da Coreia , Pacientes Internados , Resultado do Tratamento , Medição da Dor , Região LombossacralRESUMO
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 19-70 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.
RESUMO
BACKGROUND: Presentation of musculoskeletal symptoms, such as pain, discomfort, or disability, caused by a traffic accident (TA) is a common occurrence. However, studies on treatment and management of sudden low back pain (LBP) caused by a TA are very scarce, while studies on the effectiveness of motion style acupuncture therapy (MSAT) used on such patients are also rare. Accordingly, a randomized controlled trial (RCT) is planned to assess the effectiveness and safety of MSAT using traction (T-MSAT) for the treatment of pain and functional problems in patients with acute LBP caused by a TA. METHODS: This study will be conducted at Jaseng Hospital of Korean Medicine in South Korea, using a two-armed, parallel, assessor-blinded RCT design. The study population will consist of 100 participants who will be randomly assigned in a 1:1 ratio to either the T-MSAT+integrative Korean medicine therapy (IKMT) group or IKMT control group. The treatment will be applied continuously for 3 days after admission. The primary outcome will be the difference between the numeric rating scale (NRS) scores at admission and immediately after treatment on the fourth day of admission. Secondary outcomes will include visual analogue scale (VAS) for LBP and radiating leg pain; NRS for radiating leg pain; lumbar active range of motion; Oswestry Disability Index (ODI); Patient Global Impression of Change (PGIC); the Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5-K); and 12-item short-form health survey (SF-12). DISCUSSION: This study is a RCT to assess the effectiveness and safety of T-MSAT for acute LBP caused by a TA. The findings could be used by healthcare-related policy makers and clinicians in primary care institutions, which are frequently visited by patients suffering from LBP caused by a TA.