The Effectiveness and safety of T-MSAT on inpatients with acute low back pain caused by traffic accidents: A protocol for randomized controlled trial

Abstract

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.

Figure 1

Trial flow. D/C = discharge, F/U = follow-up, LBP = lower back pain, NRS = numeric rating scale, ODI = Oswestry Disability Index, PCL-5-K = Post-traumatic Stress Disorder Checklist for DSM-5, PGIC = Patient Global Impression of Change, ROM = range of motion, SF-12 = 12-item short-form health survey, VAS = visual analogue scale.