Efficacy and Safety of Acupuncture for Degenerative Lumbar Spinal Stenosis
Condition: Degenerative Lumbar Spinal Stenosis
MeSH terms: Spinal Stenosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      Degenerative Lumbar spinal stenosis (DLSS) is a major problem for public health and the
      primary reason the older seek lumbar spine surgery. Acupuncture is safe and maybe effective
      for DLSS but the evidence is poor. Therefore, an objective assessment of acupuncture efficacy
      is critical for making informed decisions about its appropriate role for patients. A total of
      80 participants meet prior inclusion criteria will be recruited. The participants will be
      allocated to acupuncture group or placebo needle (unpenetrated acupuncture) group randomly.
      Twenty-four treatments will be provided over 8 weeks. The primary change of Modified
      Roland-Morris Disability Questionnaire (RMDQ) and secondary outcomes including the change of
      Number Rating Scale (NRS); the change of Self-paced Walking test (SPWT); the change of Swiss
      Spinal Stenosis Questionnaire (SSSQ); the expectations that acupuncture might help
      participants with DLSS. All outcomes will be assessed at baseline, and/or after 4, 8, 20 and
      32 weeks. Statistical analysis will include independent sample t-test, Chi-squared test and
      non-parametric test. The investigators hope the result of this trial will clarify the value
      of acupuncture for DLSS and help clinicians make proper decisions.
    


Intervention name(s): acupuncture; placebo needle
Intervention type(s): Device; Device
Intervention description(s): Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57), Taixi (KI3) acupoints will be used. For bilateral Dachangshu (BL 25), the needle will be inserted vertically at approximately 40-70 mm until participants got a electric shock feeling downward to calves, then the needle should be elevated up 2 mm, without rotating or lifting. For other four acupoints (BL23, BL40, BL57, KI3), they will be inserted 10 to 15 mm in depth with three times light amplitude rotation and lift to induce a sensation of soreness. The manipulations will be performed 3 times in total during 1 session (every 10 min). There are 24 treatment sessions after baseline, 3 times a week, and the patients will undergo a 30-min treatment each session.; Acupuncturists will use blunt tip needles (Huatuo, Suzhou, China) that cannot penetrate skin and stimulate deep tissues, and the thrusting and twisting motions will be used by acupuncturists to simulate the treatment and blind the patients. Each placebo needle consists of four parts: needle handle, needle body, blunt tip and adhesive pad. The chosen of acupoints, treatment duration, and frequency of sessions will be the same as the acupuncture group. To guarantee blinding, the investigators will make appointments with each participant on alternate days to prevent crosstalk among groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: degenerative lumbar spinal stenosis; acupuncture; randomized controlled trial