PMID- 29742708
OWN - NLM
STAT- MEDLINE
DCOM- 20180516
LR  - 20210109
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 97
IP  - 19
DP  - 2018 May
TI  - The effectiveness and safety of nonsurgical integrative interventions for 
      symptomatic lumbar spinal spondylolisthesis: A randomized controlled 
      multinational, multicenter trial protocol.
PG  - e0667
LID - 10.1097/MD.0000000000010667 [doi]
LID - e0667
AB  - BACKGROUND: Surgery is generally accepted as the main therapeutic option for 
      symptomatic lumbar spondylolisthesis. However, new nonsurgical therapeutic 
      options need to be explored for this population. OBJECTIVES: The objective of 
      this study is to assess the effectiveness and safety of a 5-week Mokhuri 
      treatment program compared with conventional nonsurgical treatments for 
      symptomatic lumbar spondylolisthesis. METHODS: This is a study protocol for a 
      multinational, multicenter clinical randomized controlled trial comparing the 
      effectiveness and safety of 5 weeks of nonsurgical integrative treatments (a 
      Mokhuri treatment program consisting of Chuna, acupuncture, and patient 
      education) with nonsurgical conventional treatments (drugs for pain relief, 
      epidural steroid injections, and physical therapy). Clinical outcomes including 
      visual analogue scale (VAS) scores ranging from 0 to 100 for low back pain and 
      leg pain, EQ-5D scores, Oswestry disability index (ODI) scores, Roland-Morris 
      Disability Questionnaire (RMDQ) scores, Zurich Claudication Questionnaire (ZCQ) 
      scores, walking duration and distance without leg pain, and a 5-minute treadmill 
      test, and the ratio between the actual duration of participation and the 
      originally scheduled duration in each group, the presence of any additional 
      spondylolisthesis treatments, the types of concomitant treatments during the 
      follow-up period, and adverse events (AEs) will be assessed at 7 weeks, 18 weeks, 
      30 weeks, 54 weeks, and 102 weeks after the end of the treatments. CONCLUSION AND 
      DISCUSSION: The results of this study will provide clinical evidence on 
      nonsurgical integrative interventions for patients with symptomatic lumbar 
      spondylolisthesis. CLINICAL TRIAL REGISTRY:: clinicaltrials.gov (NCT03107468).
FAU - Kim, Kiok
AU  - Kim K
AD  - Department of Spine Center, Mokhuri Neck and Back Hospital, Seoul Hongik 
      Neurosurgery Hospital, Seongnam, Republic of Korea Department of Physical 
      Medicine and Rehabilitation Department of Anesthesiology, Division of Pain 
      Medicine, Mayo Clinic, Rochester, MN, USA Korean Medicine Clinical Trial Center, 
      Korean Medicine Hospital, Kyung Hee University, Seoul, Republic of Korea.
FAU - Youn, Yousuk
AU  - Youn Y
FAU - Lee, Sang Ho
AU  - Lee SH
FAU - Choi, Jung Chul
AU  - Choi JC
FAU - Jung, Jae Eun
AU  - Jung JE
FAU - Kim, Jaehong
AU  - Kim J
FAU - Qu, Wenchun
AU  - Qu W
FAU - Eldrige, Jason
AU  - Eldrige J
FAU - Kim, Tae-Hun
AU  - Kim TH
LA  - eng
SI  - ClinicalTrials.gov/NCT03107468
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Adrenal Cortex Hormones)
RN  - 0 (Analgesics)
SB  - IM
MH  - *Acupuncture Therapy/adverse effects
MH  - Adrenal Cortex Hormones/administration & dosage
MH  - Adult
MH  - Aged
MH  - Analgesics/therapeutic use
MH  - Clinical Protocols
MH  - Humans
MH  - Injections, Epidural
MH  - International Cooperation
MH  - *Lumbar Vertebrae
MH  - Middle Aged
MH  - Pain/prevention & control
MH  - *Patient Education as Topic
MH  - Physical Therapy Modalities
MH  - Sample Size
MH  - Spondylolisthesis/drug therapy/physiopathology/*therapy
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC5959416
COIS- The authors have no conflicts of interest to disclose.
EDAT- 2018/05/10 06:00
MHDA- 2018/05/17 06:00
PMCR- 2018/05/11
CRDT- 2018/05/10 06:00
PHST- 2018/05/10 06:00 [entrez]
PHST- 2018/05/10 06:00 [pubmed]
PHST- 2018/05/17 06:00 [medline]
PHST- 2018/05/11 00:00 [pmc-release]
AID - 00005792-201805110-00027 [pii]
AID - MD-D-18-02557 [pii]
AID - 10.1097/MD.0000000000010667 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2018 May;97(19):e0667. doi: 10.1097/MD.0000000000010667.