PMID- 36923649
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230316
IS  - 1178-7090 (Print)
IS  - 1178-7090 (Electronic)
IS  - 1178-7090 (Linking)
VI  - 16
DP  - 2023
TI  - A Protocol for a Single-Centered, Pragmatic, Randomized, Controlled, Parallel 
      Trial Comparing Comprehensive Nonsurgical Therapy Options for Individuals with 
      Lumbar Spinal Stenosis.
PG  - 773-784
LID - 10.2147/JPR.S398897 [doi]
AB  - AIM: Lumbar spinal stenosis (LSS) is a long-term degenerative disease. 
      Considering the risks and advantages of the patient's age range and the 
      characteristics of the condition, non-surgical treatment is recommended. To 
      determine the best first-line non-surgical therapy for LSS, few studies have 
      examined different non-surgical therapies. Therefore, the main objective of this 
      study is to determine whether the selection of comprehensive Chinese medicine 
      (CM) treatment for LSS is more successful than non-surgical conservative 
      treatment. PATIENTS AND METHODS: In this two-armed, parallel, single-centered, 
      pragmatic randomized controlled study, 94 LSS participants will be randomized to 
      receive 24 sessions of comprehensive CM therapy or conservative treatment for 3 
      months, with follow-up assessments at 6, 9, 12, and 15 months. The primary 
      outcome will be based on the success rate of the Zurich Claudication 
      Questionnaire (ZCQ) for the most clinical important difference (MCID) at 3 and 15 
      months. Secondary outcomes include Numerical Rating Scale (NRS) scores for back 
      and leg pain, ZCQ scores, Oswestry Disability Index scores for lumbar 
      dysfunction, and Short-Form 12 scores for health-related quality of life at 3, 6, 
      9, 12, and 15 months. Adverse events and incidences of surgery will be reported 
      anytime during the trial and follow-up. CONCLUSION: This protocol examines the 
      comparative efficacy of comprehensive CM therapy compared with conventional care 
      through a pragmatic randomized controlled trial to present data to facilitate 
      clinical or policy decision-making. The outcomes will make it easier to decide 
      which patient-centered treatments to prioritize for LSS.
CI  - (c) 2023 Sun et al.
FAU - Sun, Ya'nan
AU  - Sun Y
AD  - Traditional Chinese Medicine Department, Xuanwu Hospital Capital Medical 
      University, Beijing, People's Republic of China.
FAU - An, Yi
AU  - An Y
AD  - First Clinical College, Beijing University of Chinese Medicine Affiliated 
      Dongzhimen Hospital, Beijing, People's Republic of China.
FAU - Fan, Xiran
AU  - Fan X
AD  - First Clinical College, Beijing University of Chinese Medicine Affiliated 
      Dongzhimen Hospital, Beijing, People's Republic of China.
FAU - Liu, Changxin
AU  - Liu C
AD  - Tuina and Pain Management Department, Beijing University of Chinese Medicine 
      Affiliated Dongzhimen Hospital, Beijing, People's Republic of China.
FAU - Li, Duoduo
AU  - Li D
AD  - Tuina and Pain Management Department, Beijing University of Chinese Medicine 
      Affiliated Dongzhimen Hospital, Beijing, People's Republic of China.
FAU - Lei, Yuan
AU  - Lei Y
AD  - Tuina and Pain Management Department, Beijing University of Chinese Medicine 
      Affiliated Dongzhimen Hospital, Beijing, People's Republic of China.
FAU - Weng, Zhiwen
AU  - Weng Z
AD  - Tuina and Pain Management Department, Beijing University of Chinese Medicine 
      Affiliated Dongzhimen Hospital, Beijing, People's Republic of China.
FAU - Gong, Yuanyuan
AU  - Gong Y
AD  - Tuina and Pain Management Department, Beijing University of Chinese Medicine 
      Affiliated Dongzhimen Hospital, Beijing, People's Republic of China.
FAU - Wang, Xiyou
AU  - Wang X
AD  - Tuina and Pain Management Department, Beijing University of Chinese Medicine 
      Affiliated Dongzhimen Hospital, Beijing, People's Republic of China.
FAU - Yu, Changhe
AU  - Yu C
AD  - Tuina and Pain Management Department, Beijing University of Chinese Medicine 
      Affiliated Dongzhimen Hospital, Beijing, People's Republic of China.
LA  - eng
PT  - Journal Article
DEP - 20230309
PL  - New Zealand
TA  - J Pain Res
JT  - Journal of pain research
JID - 101540514
PMC - PMC10010744
OTO - NOTNLM
OT  - Chinese medicine
OT  - comprehensive treatment
OT  - conservative treatment
OT  - lumbar spinal stenosis
OT  - patient centered
OT  - pragmatic randomized controlled trial
COIS- The authors declare that they have no conflicts of interest.
EDAT- 2023/03/17 06:00
MHDA- 2023/03/17 06:01
PMCR- 2023/03/09
CRDT- 2023/03/16 02:26
PHST- 2022/12/03 00:00 [received]
PHST- 2023/02/20 00:00 [accepted]
PHST- 2023/03/16 02:26 [entrez]
PHST- 2023/03/17 06:00 [pubmed]
PHST- 2023/03/17 06:01 [medline]
PHST- 2023/03/09 00:00 [pmc-release]
AID - 398897 [pii]
AID - 10.2147/JPR.S398897 [doi]
PST - epublish
SO  - J Pain Res. 2023 Mar 9;16:773-784. doi: 10.2147/JPR.S398897. eCollection 2023.