Nonsurgical integrative inpatient treatments for symptomatic lumbar spinal stenosis: a multi-arm randomized controlled pilot trial

Kiok Kim,1,* Kyung-Min Shin,2,* Christy L Hunt,3 Zhen Wang,4 Brent A Bauer,5 Ojin Kwon,2 Jun-Hwan Lee,2,6 Bok-Nam Seo,7 So-Young Jung,2 Yousuk Youn,1 Sang Ho Lee,1 Jung Chul Choi,1 Jae Eun Jung,8 Jaehong Kim,1 Wenchun Qu,3,9 Tae-Hun Kim,10 Jason S Eldrige9 1Department of Spine Center, Mokhuri Neck & Back Hospital, Seoul, South Korea; 2Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, South Korea; 3Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, MN, USA; 4Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA; 5Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA; 6Korean Medicine Life Science, Campus of Korea Institute of Oriental Medicine, University of Science & Technology (UST), Daejeon, South Korea; 7Future Medicine Division, Korea Institute of Oriental Medicine, Daejeon, South Korea; 8Hongik Neurosurgery Hospital, Seongnam, South Korea; 9Department of Anesthesiology, Division of Pain Medicine, Mayo Clinic, Rochester, MN, USA; 10Korean Medicine Clinical Trial Center, Korean Medicine Hospital, Kyung Hee University, Seoul, South Korea *These authors contributed equally to this work Background: Lumbar spinal stenosis (LSS) is a chronic condition that causes low back pain and neurogenic claudication, often resulting in significant limitation of daily activities. In this open-label randomized controlled pilot study, we assessed the safety and feasibility of 4-week novel integrative inpatient treatments for LSS. Methods: Thirty-six symptomatic LSS patients were randomly and equally allocated to one of the three groups: Mokhuri Chuna treatment 1 (MT1) group, Mokhuri Chuna treatment 2 (MT2) group, or conventional management treatment (CMT) group. MT1 patients were treated with herbal medication, Mokhuri Chuna, and acupuncture, and received daily physician consultation; MT2 patients were treated with Mokhuri Chuna and acupuncture without any herbal medication, and received daily physician consultation; and CMT patients received conventional pain management therapy that included epidural steroid injection, oral NSAID, and muscle relaxant medication, along with daily physiotherapy. The primary outcome of this pilot study was safety as measured by the type and incidence of adverse events (AEs). The secondary outcome measures included VAS score for low back pain and leg pain, Oswestry Disability Index, Oxford Claudication Score (OCS), walking capacity on a 50 m flat track and treadmill, and EuroQol-5D score. Magnetic resonance imaging was also performed up to 6 months after treatment cessation. Results: Thirty-four treated patients were included in the analysis, based on the modified intention-to-treat principle. No serious AEs were observed or reported. Compared to the CMT group, the MT1 and MT2 groups did show significant improvement at 3 and 6 months in various domains, including pain (VAS score for leg and back pain) and function (OCS and treadmill walking). Conclusion: These novel multimodal integrative treatments for LSS are both clinically safe and logistically feasible. Larger, adequately powered randomized controlled trials will be necessary to assess comparative efficacy and thoroughly analyze the cost-effectiveness of each treatment approach. Clinical trial registration number (CRIS): KCT0001218. Keywords: lumbar spinal stenosis, complementary and alternative medicine, acupuncture, Chuna, epidural steroid injection, low back pain