title: Efficacy of acupuncture for degenerative lumbar spinal stenosis: protocol for a randomised sham acupuncture-controlled trial.
abstract: Degenerative lumbar spinal stenosis (DLSS) is a major public health problem and the primary reason why older adults seek lumbar spine surgery. Acupuncture may be effective for DLSS, but the evidence supporting this possibility is still limited.
  
  
  
  A total of 80 participants with DLSS will be randomly allocated to either an acupuncture group or a sham acupuncture (SA) group at a ratio of 1:1. 24 treatments will be provided over 8 weeks. The primary outcome is the score change of the Modified Roland-Morris Disability Questionnaire (RMDQ) responses from baseline to week 8. The secondary outcomes include the assessment of lower back pain and leg pain using the Numeric Rating Scale (NRS), the change in the number of steps per month, and the assessment of the specific quality of life using the Swiss Spinal Stenosis Questionnaire (SSSQ). We will follow-up with the participants until week 32. All of the participants who received allocation will be included in the statistical analysis.
  
  
  
  This protocol has been approved by the Research Ethical Committee of Guang'anmen Hospital (Permission number: 2015EC114) and Fengtai Hospital of Integrated Traditional and Western Medicine (Permission number: 16KE0409). The full data set will be made available when this trial is completed and published. Applications for the release of data should be made to ZL (principal investigator).
  
  
  
  NCT02644746.
authors.affiliation: Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.|Beijing University of Chinese Medicine, Beijing, China.
authors.forename: Zongshi
authors.initials: Z
authors.lastname: Qin
authors.affiliation: Department of Acupuncture, Beijing Fengtai Hospital of Integrated Traditional and Western Medicine, Beijing, China.
authors.forename: Yulong
authors.initials: Y
authors.lastname: Ding
authors.affiliation: Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
authors.forename: Jiani
authors.initials: J
authors.lastname: Wu
authors.affiliation: Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.|Beijing University of Chinese Medicine, Beijing, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Zhou
authors.affiliation: Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
authors.forename: Likun
authors.initials: L
authors.lastname: Yang
authors.affiliation: Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.|Beijing University of Chinese Medicine, Beijing, China.
authors.forename: Xiaoxu
authors.initials: X
authors.lastname: Liu
authors.affiliation: Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
authors.forename: Zhishun
authors.initials: Z
authors.lastname: Liu
mesh_terms: D015670:Acupuncture Therapy / Q000379:methods*; D000368:Aged; D000369:Aged, 80 and over; D002681:China; D002985:Clinical Protocols; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000628:therapy; D008159:Lumbar Vertebrae / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011788:Quality of Life; D013130:Spinal Stenosis / Q000628:therapy*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
keywords: Lumbar spinal stenosis; acupuncture; efficacy; randomized controlled trial