<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03784729</url>
  </required_header>
  <id_info>
    <org_study_id>2018-161-KY</org_study_id>
    <nct_id>NCT03784729</nct_id>
  </id_info>
  <brief_title>Efficacy of Acupuncture for Lumbar Spinal Stenosis</brief_title>
  <official_title>Efficacy of Acupuncture for Intermittent Claudication of Patients With Lumbar Spinal Stenosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Degenerative lumbar spinal stenosis (DLSS) is a condition which there is narrowing space of&#xD;
      sagittal diameter of spinal canal or nerve root canal for spinal nerve or cauda equina&#xD;
      secondary to degenerative changes. DLSS is a common cause of gluteal or lower extremity pain,&#xD;
      women and elderly people aged 60-70 are more likely to have DLSS. The early symptoms of this&#xD;
      disease are soreness and pain in the low back, gluteal region and posterior region of thighs&#xD;
      which can be relieved after resting or changing posture. Being accompanied with gradually&#xD;
      aggravated symptoms, patients with DLSS may have neurogenic claudication with hypoesthesia&#xD;
      and numbness in lateral lower legs and feet, additionally, few patients may have bowel and&#xD;
      bladder disturbances. In accordance of the guidelines of North American Spine Society (NASS),&#xD;
      treatment options comprise surgical therapy, epidural steroid injections and physical therapy&#xD;
      and transcutaneous electrical stimulation, however, the long-term efficacy of surgery is not&#xD;
      superior to that of non-surgical therapy. Moreover, the short-term efficacy of non-surgical&#xD;
      therapy is with insufficient evidence. According to a systematic review and recent studies,&#xD;
      acupuncture may improve the symptoms of patients and their quality of life, however, there is&#xD;
      a lack of placebo-controlled and large sample sized study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 25, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change in Modified Roland-Morris Disability Questionnaire (RMDQ) score from baseline</measure>
    <time_frame>week 6</time_frame>
    <description>Modified Roland-Morris Disability Questionnaire (RMDQ) is a reliable pain-specific functional status questionnaire which is easy and simple for patients to complete. The RMDQ includes 24 questions with a score range of 0-24, and there is a phrase &quot;caused by low back pain&quot; after each question which could excluded other reasons for dysfunction of the back. For this scale, higher scores indicate more severe symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change in Modified Roland-Morris Disability Questionnaire (RMDQ) score from baseline</measure>
    <time_frame>week 18</time_frame>
    <description>Modified Roland-Morris Disability Questionnaire (RMDQ) is a reliable pain-specific functional status questionnaire which is easy and simple for patients to complete. The RMDQ includes 24 questions with a score range of 0-24, and there is a phrase &quot;caused by low back pain&quot; after each question which could excluded other reasons for dysfunction of the back. For this scale, higher scores indicate more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in Modified Roland-Morris Disability Questionnaire (RMDQ) score from baseline</measure>
    <time_frame>week 30</time_frame>
    <description>Modified Roland-Morris Disability Questionnaire (RMDQ) is a reliable pain-specific functional status questionnaire which is easy and simple for patients to complete. The RMDQ includes 24 questions with a score range of 0-24, and there is a phrase &quot;caused by low back pain&quot; after each question which could excluded other reasons for dysfunction of the back. For this scale, higher scores indicate more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of participants with at least 30% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)</measure>
    <time_frame>week 6</time_frame>
    <description>Modified Roland-Morris Disability Questionnaire (RMDQ) is a reliable pain-specific functional status questionnaire including 24 questions with a score range of 0-24. For this scale, higher scores indicate more severe symptoms. The proportion of patients wtih a reduction of at least 30% from baseline in the RMDQ will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of participants with at least 30% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)</measure>
    <time_frame>week 18</time_frame>
    <description>Modified Roland-Morris Disability Questionnaire (RMDQ) is a reliable pain-specific functional status questionnaire including 24 questions with a score range of 0-24. For this scale, higher scores indicate more severe symptoms. The proportion of patients wtih a reduction of at least 30% from baseline in the RMDQ will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of participants with at least 30% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)</measure>
    <time_frame>week 30</time_frame>
    <description>Modified Roland-Morris Disability Questionnaire (RMDQ) is a reliable pain-specific functional status questionnaire including 24 questions with a score range of 0-24. For this scale, higher scores indicate more severe symptoms. The proportion of patients wtih a reduction of at least 30% from baseline in the RMDQ will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of participants with at least 50% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)</measure>
    <time_frame>week 6</time_frame>
    <description>Modified Roland-Morris Disability Questionnaire (RMDQ) is a reliable pain-specific functional status questionnaire including 24 questions with a score range of 0-24. For this scale, higher scores indicate more severe symptoms. The proportion of patients wtih a reduction of at least 50% from baseline in the RMDQ will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of participants with at least 50% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)</measure>
    <time_frame>week 18</time_frame>
    <description>Modified Roland-Morris Disability Questionnaire (RMDQ) is a reliable pain-specific functional status questionnaire including 24 questions with a score range of 0-24. For this scale, higher scores indicate more severe symptoms. The proportion of patients wtih a reduction of at least 50% from baseline in the RMDQ will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of participants with at least 50% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)</measure>
    <time_frame>week 30</time_frame>
    <description>Modified Roland-Morris Disability Questionnaire (RMDQ) is a reliable pain-specific functional status questionnaire including 24 questions with a score range of 0-24. For this scale, higher scores indicate more severe symptoms. The proportion of patients wtih a reduction of at least 50% from baseline in the RMDQ will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back as measured by the Number Rating Scale (NRS) in the previous 1 week from baseline</measure>
    <time_frame>week 6</time_frame>
    <description>NRS is a brief scale for assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back as measured by the Number Rating Scale (NRS) in the previous 1 week from baseline</measure>
    <time_frame>week 18</time_frame>
    <description>NRS is a brief scale for assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back as measured by the Number Rating Scale (NRS) in the previous 1 week from baseline</measure>
    <time_frame>week 30</time_frame>
    <description>NRS is a brief scale for assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>At least 30% reductions from baseline in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back, as measured by the Number Rating Scale (NRS) for the previous 1 week</measure>
    <time_frame>week 6</time_frame>
    <description>NRS is a brief scale for assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>At least 30% reductions from baseline in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back, as measured by the Number Rating Scale (NRS) for the previous 1 week</measure>
    <time_frame>week 18</time_frame>
    <description>NRS is a brief scale for assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>At least 30% reductions from baseline in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back, as measured by the Number Rating Scale (NRS) for the previous 1 week</measure>
    <time_frame>week 30</time_frame>
    <description>NRS is a brief scale for assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>At least 50% reductions from baseline in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back, as measured by the Number Rating Scale (NRS) for the previous 1 week</measure>
    <time_frame>week 6</time_frame>
    <description>NRS is a brief scale for assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>At least 50% reductions from baseline in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back, as measured by the Number Rating Scale (NRS) for the previous 1 week</measure>
    <time_frame>week 18</time_frame>
    <description>NRS is a brief scale for assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>At least 50% reductions from baseline in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back, as measured by the Number Rating Scale (NRS) for the previous 1 week</measure>
    <time_frame>week 30</time_frame>
    <description>NRS is a brief scale for assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in symptom severity domain from baseline</measure>
    <time_frame>week 6</time_frame>
    <description>SSSQ is a short outcome measure for symptoms and functions. SSSQ consists of 18 questions and three domains including symptom severity, physical function and satisfaction with the degree of treatment. For all these three domains, scores for each domain is calculated by total score of this domain divide the number of answered questions, and if more than two items are missing, the scale scores for this domain are considered missing. Six questions in the symptom severity domain assess back, buttocks, legs or feet pain, pain frequency, numbness, weakness with scores ranging from 1 to 5 while one question assesses balance with scores ranging from 1, 3 and 5 and higher scores indicating worse symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in symptom severity domain from baseline</measure>
    <time_frame>week 18</time_frame>
    <description>SSSQ is a short outcome measure for symptoms and functions. SSSQ consists of 18 questions and three domains including symptom severity, physical function and satisfaction with the degree of treatment. For all these three domains, scores for each domain is calculated by total score of this domain divide the number of answered questions, and if more than two items are missing, the scale scores for this domain are considered missing. Six questions in the symptom severity domain assess back, buttocks, legs or feet pain, pain frequency, numbness, weakness with scores ranging from 1 to 5 while one question assesses balance with scores ranging from 1, 3 and 5 and higher scores indicating worse symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in symptom severity domain from baseline</measure>
    <time_frame>week 30</time_frame>
    <description>SSSQ is a short outcome measure for symptoms and functions. SSSQ consists of 18 questions and three domains including symptom severity, physical function and satisfaction with the degree of treatment. For all these three domains, scores for each domain is calculated by total score of this domain divide the number of answered questions, and if more than two items are missing, the scale scores for this domain are considered missing. Six questions in the symptom severity domain assess back, buttocks, legs or feet pain, pain frequency, numbness, weakness with scores ranging from 1 to 5 while one question assesses balance with scores ranging from 1, 3 and 5 and higher scores indicating worse symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in physical function domain from baseline</measure>
    <time_frame>week 6</time_frame>
    <description>SSSQ is a short outcome measure for symptoms and functions. SSSQ consists of 18 questions and three domains including symptom severity, physical function and satisfaction with the degree of treatment. For all these three domains, scores for each domain is calculated by total score of this domain divide the number of answered questions, and if more than two items are missing, the scale scores for this domain are considered missing. The physical function domain assessing walking distance and ability to walk for pleasures, for shopping and for getting around the house or apartment and from bathroom to bedroom has 5 questions with scores ranging from 1 to 4 and higher scores indicating less satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in physical function domain from baseline</measure>
    <time_frame>week 18</time_frame>
    <description>SSSQ is a short outcome measure for symptoms and functions. SSSQ consists of 18 questions and three domains including symptom severity, physical function and satisfaction with the degree of treatment. For all these three domains, scores for each domain is calculated by total score of this domain divide the number of answered questions, and if more than two items are missing, the scale scores for this domain are considered missing. The physical function domain assessing walking distance and ability to walk for pleasures, for shopping and for getting around the house or apartment and from bathroom to bedroom has 5 questions with scores ranging from 1 to 4 and higher scores indicating less satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in physical function domain from baseline</measure>
    <time_frame>week 30</time_frame>
    <description>SSSQ is a short outcome measure for symptoms and functions. SSSQ consists of 18 questions and three domains including symptom severity, physical function and satisfaction with the degree of treatment. For all these three domains, scores for each domain is calculated by total score of this domain divide the number of answered questions, and if more than two items are missing, the scale scores for this domain are considered missing. The physical function domain assessing walking distance and ability to walk for pleasures, for shopping and for getting around the house or apartment and from bathroom to bedroom has 5 questions with scores ranging from 1 to 4 and higher scores indicating less satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in satisfaction domain from baseline</measure>
    <time_frame>week 6</time_frame>
    <description>SSSQ is a short outcome measure for symptoms and functions. SSSQ consists of 18 questions and three domains including symptom severity, physical function and satisfaction with the degree of treatment. For all these three domains, scores for each domain is calculated by total score of this domain divide the number of answered questions, and if more than two items are missing, the scale scores for this domain are considered missing. The satisfaction domain has four categories (very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied) with a score range of 1 to 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in satisfaction domain from baseline</measure>
    <time_frame>week 18</time_frame>
    <description>SSSQ is a short outcome measure for symptoms and functions. SSSQ consists of 18 questions and three domains including symptom severity, physical function and satisfaction with the degree of treatment. For all these three domains, scores for each domain is calculated by total score of this domain divide the number of answered questions, and if more than two items are missing, the scale scores for this domain are considered missing. The satisfaction domain has four categories (very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied) with a score range of 1 to 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in satisfaction domain from baseline</measure>
    <time_frame>week 30</time_frame>
    <description>SSSQ is a short outcome measure for symptoms and functions. SSSQ consists of 18 questions and three domains including symptom severity, physical function and satisfaction with the degree of treatment. For all these three domains, scores for each domain is calculated by total score of this domain divide the number of answered questions, and if more than two items are missing, the scale scores for this domain are considered missing. The satisfaction domain has four categories (very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied) with a score range of 1 to 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of participants with somewhat satisfied in the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)</measure>
    <time_frame>week 6</time_frame>
    <description>The proportion of patients with 2 points in the satisfaction domain of SSSQ.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of participants with somewhat satisfied in the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)</measure>
    <time_frame>week 18</time_frame>
    <description>The proportion of patients with 2 points in the satisfaction domain of SSSQ.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of participants with somewhat satisfied in the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)</measure>
    <time_frame>week 30</time_frame>
    <description>The proportion of patients with 2 points in the satisfaction domain of SSSQ.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of participants with very satisfied based on the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)</measure>
    <time_frame>week 6</time_frame>
    <description>The proportion of patients with 1 points in the satisfaction domain of SSSQ.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of participants with very satisfied based on the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)</measure>
    <time_frame>week 18</time_frame>
    <description>The proportion of patients with 1 points in the satisfaction domain of SSSQ.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of participants with very satisfied based on the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)</measure>
    <time_frame>week 30</time_frame>
    <description>The proportion of patients with 1 points in the satisfaction domain of SSSQ.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of Hospital Anxiety and Depression Scale (HADS) score from baseline</measure>
    <time_frame>week 6</time_frame>
    <description>HADS is validated and standardized for measuring the state of anxiety and depression. HADS has 2 subscales with 14 items (7 items each), and a total score of 0 to 21 with 0 to 3 for each item.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of Hospital Anxiety and Depression Scale (HADS) score from baseline</measure>
    <time_frame>week 18</time_frame>
    <description>HADS is validated and standardized for measuring the state of anxiety and depression. HADS has 2 subscales with 14 items (7 items each), and a total score of 0 to 21 with 0 to 3 for each item.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of Hospital Anxiety and Depression Scale (HADS) score from baseline</measure>
    <time_frame>week 30</time_frame>
    <description>HADS is validated and standardized for measuring the state of anxiety and depression. HADS has 2 subscales with 14 items (7 items each), and a total score of 0 to 21 with 0 to 3 for each item.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The proportion of patients who have expectancy of acupuncture</measure>
    <time_frame>Baseline</time_frame>
    <description>Expectancy of acupuncture will be recorded at baseline. Participants will be required to answer two questions: &quot;In general, do you believe acupuncture is effective for treating the illness?&quot; and &quot;Do you think acupuncture will be helpful to improve your symptoms of DLSS?&quot; Participants could choose &quot;Unclear&quot;, &quot;Yes&quot; or &quot;No&quot; as the answer.</description>
  </other_outcome>
  <other_outcome>
    <measure>The proportion of patients with successful blinding</measure>
    <time_frame>Week 6</time_frame>
    <description>Patients will be asked to answer the following questions after treatment (sessions 17 or 18) within 5 minutes: &quot;Do you think you have received traditional acupuncture over the past 6 weeks?&quot; The patients can answer &quot;yes&quot; or &quot;no&quot;.</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>week 1 to week 30</time_frame>
    <description>AEs related to acupuncture include severe pain (assessed by VAS, 7 points at least), broken needle, fainting, local hematoma, localized infection and post-acupuncture discomfortable symptoms such as nausea, vomiting, palpitation, dizziness, headache, anorexia and insomnia, etc. during treatment period. Adverse events irrelevant with the treatment will also be recorded in detail.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">196</enrollment>
  <condition>Lumbar Spinal Stenosis</condition>
  <condition>Intermittent Claudication</condition>
  <arm_group>
    <arm_group_label>Acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The acupoints of Shenshu (BL23), &quot;Dachangshu (BL25)&quot;, Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham acupuncture</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The acupoints of Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted into a depth of 2-3mm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <description>The acupoints of Shenshu (BL23), &quot;Dachangshu (BL25)&quot;, Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted. For the bilateral&quot; BL25&quot;, sterile disposable steel needles (Huatuo, Suzhou, China; 0.3 mm×75 mm) will be inserted to a depth of 50-70mm until until participates feel a sensation similar to electric shock radiating downward to the knees. For the other four acupoints (BL23, BL40, BL57 and KI3), the needles (Huatuo, Suzhou, China; 0.3 mm×40 mm) will be inserted to a depth of 15-25 mm, gently rotated three times and lifted to achieve de qi. It should be noted that the needle at KI3 will be inserted at an angle of 45°obliquely downward. There will be 18 treatment sessions with 3 times a week for continuous 6 weeks and a 30 min treatment per session.</description>
    <arm_group_label>Acupuncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham acupuncture</intervention_name>
    <description>The acupoints of Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted into a depth of 2-3mm .No manipulation of needles without deqi will be conducted. The treatment duration and frequency of sessions for participants in the SA group will be the same as in the acupuncture group.</description>
    <arm_group_label>Sham acupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meet the requirements for a clinical diagnosis of DLSS combined with a MRI- or&#xD;
             computed tomography (CT)-based radiological diagnosis of central sagittal diameter&#xD;
             stenosis of the lumbar spinal canal;&#xD;
&#xD;
          -  Have neurogenic intermittent claudication (IC) characterized by progressive pain,&#xD;
             numbness, weakness, and tingling of the buttocks and/or legs when standing or walking&#xD;
             or with extension of the back, which are relieved upon sitting, lying down, or bending&#xD;
             forward [22]; they must always walk in flexion or hunchback posture;&#xD;
&#xD;
          -  Have pain of an intensity ≥4 in the buttocks and/or legs when walking, standing, or&#xD;
             extending the back, as measured using the Numerical Rating Scale (NRS);&#xD;
&#xD;
          -  Have pain in the buttock and/or leg that is more severe than their pain in the lower&#xD;
             back;&#xD;
&#xD;
          -  Have a Roland-Morris score of at least 7;&#xD;
&#xD;
          -  Have received a MRI or CT scan within 1 year that showed the anterior posterior&#xD;
             diameter of the canal was ≤12 mm;&#xD;
&#xD;
          -  Are aged 50-80 years;&#xD;
&#xD;
          -  Have provided signed consent and exhibit willingness to participate in the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Congenital stenosis of the vertebral canal, indications of surgery for DLSS (e.g.,&#xD;
             segmental muscular atrophy, bowel and bladder disturbances), spinal instability&#xD;
             requiring surgery, lumbar tuberculosis, lumbar metastatic carcinoma, or vertebral&#xD;
             body/vertebral stenosis segment compression fracture;&#xD;
&#xD;
          -  Severe vascular, pulmonary, or coronary artery disease with limited lower extremities&#xD;
             motility;&#xD;
&#xD;
          -  Clinical comorbidities that could interfere with the collection of data related to&#xD;
             pain and walking function such as fibromyalgia, chronic widespread pain, amputation,&#xD;
             stroke, Parkinson's disease, spinal cord injury, and dementia;&#xD;
&#xD;
          -  Cognitive impairment, such that they are unable to understand the content of the&#xD;
             assessment scales or provide accurate data;&#xD;
&#xD;
          -  A history of lumbar surgery;&#xD;
&#xD;
          -  Plans to become pregnant within 12 months or are already pregnant;&#xD;
&#xD;
          -  Received acupuncture treatments for DLSS within the previous 30 days;&#xD;
&#xD;
          -  Neurogenic IC mainly manifesting as numbness, weakness, or paraesthesia of the lower&#xD;
             extremities instead of pain.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yan Liu, Master</last_name>
    <role>Study Director</role>
    <affiliation>Beijing University of Chinese Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jing Zhou, Master</last_name>
    <phone>86-010-15650729586</phone>
    <email>zjinbj@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhishun Liu, PhD</last_name>
    <phone>86-010-13651016316</phone>
    <email>zhishunjournal@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Guang An Men Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ruiming Jiao, Master</last_name>
      <phone>8610-88002331</phone>
      <email>18801247843@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</investigator_affiliation>
    <investigator_full_name>Liu Zhishun</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Intermittent Claudication</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03784729
org study id: 2018-161-KY
nct id: NCT03784729
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Degenerative lumbar spinal stenosis (DLSS) is a condition which there is narrowing space of
      sagittal diameter of spinal canal or nerve root canal for spinal nerve or cauda equina
      secondary to degenerative changes. DLSS is a common cause of gluteal or lower extremity pain,
      women and elderly people aged 60-70 are more likely to have DLSS. The early symptoms of this
      disease are soreness and pain in the low back, gluteal region and posterior region of thighs
      which can be relieved after resting or changing posture. Being accompanied with gradually
      aggravated symptoms, patients with DLSS may have neurogenic claudication with hypoesthesia
      and numbness in lateral lower legs and feet, additionally, few patients may have bowel and
      bladder disturbances. In accordance of the guidelines of North American Spine Society (NASS),
      treatment options comprise surgical therapy, epidural steroid injections and physical therapy
      and transcutaneous electrical stimulation, however, the long-term efficacy of surgery is not
      superior to that of non-surgical therapy. Moreover, the short-term efficacy of non-surgical
      therapy is with insufficient evidence. According to a systematic review and recent studies,
      acupuncture may improve the symptoms of patients and their quality of life, however, there is
      a lack of placebo-controlled and large sample sized study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: The change in Modified Roland-Morris Disability Questionnaire (RMDQ) score from baseline
time frame: week 6
description: Modified Roland-Morris Disability Questionnaire (RMDQ) is a reliable pain-specific functional status questionnaire which is easy and simple for patients to complete. The RMDQ includes 24 questions with a score range of 0-24, and there is a phrase "caused by low back pain" after each question which could excluded other reasons for dysfunction of the back. For this scale, higher scores indicate more severe symptoms.
measure: The change in Modified Roland-Morris Disability Questionnaire (RMDQ) score from baseline
time frame: week 18
description: Modified Roland-Morris Disability Questionnaire (RMDQ) is a reliable pain-specific functional status questionnaire which is easy and simple for patients to complete. The RMDQ includes 24 questions with a score range of 0-24, and there is a phrase "caused by low back pain" after each question which could excluded other reasons for dysfunction of the back. For this scale, higher scores indicate more severe symptoms.
measure: The change in Modified Roland-Morris Disability Questionnaire (RMDQ) score from baseline
time frame: week 30
description: Modified Roland-Morris Disability Questionnaire (RMDQ) is a reliable pain-specific functional status questionnaire which is easy and simple for patients to complete. The RMDQ includes 24 questions with a score range of 0-24, and there is a phrase "caused by low back pain" after each question which could excluded other reasons for dysfunction of the back. For this scale, higher scores indicate more severe symptoms.
measure: The proportion of participants with at least 30% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
time frame: week 6
description: Modified Roland-Morris Disability Questionnaire (RMDQ) is a reliable pain-specific functional status questionnaire including 24 questions with a score range of 0-24. For this scale, higher scores indicate more severe symptoms. The proportion of patients wtih a reduction of at least 30% from baseline in the RMDQ will be calculated.
measure: The proportion of participants with at least 30% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
time frame: week 18
description: Modified Roland-Morris Disability Questionnaire (RMDQ) is a reliable pain-specific functional status questionnaire including 24 questions with a score range of 0-24. For this scale, higher scores indicate more severe symptoms. The proportion of patients wtih a reduction of at least 30% from baseline in the RMDQ will be calculated.
measure: The proportion of participants with at least 30% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
time frame: week 30
description: Modified Roland-Morris Disability Questionnaire (RMDQ) is a reliable pain-specific functional status questionnaire including 24 questions with a score range of 0-24. For this scale, higher scores indicate more severe symptoms. The proportion of patients wtih a reduction of at least 30% from baseline in the RMDQ will be calculated.
measure: The proportion of participants with at least 50% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
time frame: week 6
description: Modified Roland-Morris Disability Questionnaire (RMDQ) is a reliable pain-specific functional status questionnaire including 24 questions with a score range of 0-24. For this scale, higher scores indicate more severe symptoms. The proportion of patients wtih a reduction of at least 50% from baseline in the RMDQ will be calculated.
measure: The proportion of participants with at least 50% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
time frame: week 18
description: Modified Roland-Morris Disability Questionnaire (RMDQ) is a reliable pain-specific functional status questionnaire including 24 questions with a score range of 0-24. For this scale, higher scores indicate more severe symptoms. The proportion of patients wtih a reduction of at least 50% from baseline in the RMDQ will be calculated.
measure: The proportion of participants with at least 50% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
time frame: week 30
description: Modified Roland-Morris Disability Questionnaire (RMDQ) is a reliable pain-specific functional status questionnaire including 24 questions with a score range of 0-24. For this scale, higher scores indicate more severe symptoms. The proportion of patients wtih a reduction of at least 50% from baseline in the RMDQ will be calculated.
measure: Changes in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back as measured by the Number Rating Scale (NRS) in the previous 1 week from baseline
time frame: week 6
description: NRS is a brief scale for assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain.
measure: Changes in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back as measured by the Number Rating Scale (NRS) in the previous 1 week from baseline
time frame: week 18
description: NRS is a brief scale for assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain.
measure: Changes in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back as measured by the Number Rating Scale (NRS) in the previous 1 week from baseline
time frame: week 30
description: NRS is a brief scale for assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain.
measure: At least 30% reductions from baseline in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back, as measured by the Number Rating Scale (NRS) for the previous 1 week
time frame: week 6
description: NRS is a brief scale for assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain.
measure: At least 30% reductions from baseline in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back, as measured by the Number Rating Scale (NRS) for the previous 1 week
time frame: week 18
description: NRS is a brief scale for assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain.
measure: At least 30% reductions from baseline in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back, as measured by the Number Rating Scale (NRS) for the previous 1 week
time frame: week 30
description: NRS is a brief scale for assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain.
measure: At least 50% reductions from baseline in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back, as measured by the Number Rating Scale (NRS) for the previous 1 week
time frame: week 6
description: NRS is a brief scale for assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain.
measure: At least 50% reductions from baseline in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back, as measured by the Number Rating Scale (NRS) for the previous 1 week
time frame: week 18
description: NRS is a brief scale for assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain.
measure: At least 50% reductions from baseline in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back, as measured by the Number Rating Scale (NRS) for the previous 1 week
time frame: week 30
description: NRS is a brief scale for assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain.
measure: The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in symptom severity domain from baseline
time frame: week 6
description: SSSQ is a short outcome measure for symptoms and functions. SSSQ consists of 18 questions and three domains including symptom severity, physical function and satisfaction with the degree of treatment. For all these three domains, scores for each domain is calculated by total score of this domain divide the number of answered questions, and if more than two items are missing, the scale scores for this domain are considered missing. Six questions in the symptom severity domain assess back, buttocks, legs or feet pain, pain frequency, numbness, weakness with scores ranging from 1 to 5 while one question assesses balance with scores ranging from 1, 3 and 5 and higher scores indicating worse symptoms.
measure: The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in symptom severity domain from baseline
time frame: week 18
description: SSSQ is a short outcome measure for symptoms and functions. SSSQ consists of 18 questions and three domains including symptom severity, physical function and satisfaction with the degree of treatment. For all these three domains, scores for each domain is calculated by total score of this domain divide the number of answered questions, and if more than two items are missing, the scale scores for this domain are considered missing. Six questions in the symptom severity domain assess back, buttocks, legs or feet pain, pain frequency, numbness, weakness with scores ranging from 1 to 5 while one question assesses balance with scores ranging from 1, 3 and 5 and higher scores indicating worse symptoms.
measure: The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in symptom severity domain from baseline
time frame: week 30
description: SSSQ is a short outcome measure for symptoms and functions. SSSQ consists of 18 questions and three domains including symptom severity, physical function and satisfaction with the degree of treatment. For all these three domains, scores for each domain is calculated by total score of this domain divide the number of answered questions, and if more than two items are missing, the scale scores for this domain are considered missing. Six questions in the symptom severity domain assess back, buttocks, legs or feet pain, pain frequency, numbness, weakness with scores ranging from 1 to 5 while one question assesses balance with scores ranging from 1, 3 and 5 and higher scores indicating worse symptoms.
measure: The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in physical function domain from baseline
time frame: week 6
description: SSSQ is a short outcome measure for symptoms and functions. SSSQ consists of 18 questions and three domains including symptom severity, physical function and satisfaction with the degree of treatment. For all these three domains, scores for each domain is calculated by total score of this domain divide the number of answered questions, and if more than two items are missing, the scale scores for this domain are considered missing. The physical function domain assessing walking distance and ability to walk for pleasures, for shopping and for getting around the house or apartment and from bathroom to bedroom has 5 questions with scores ranging from 1 to 4 and higher scores indicating less satisfaction.
measure: The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in physical function domain from baseline
time frame: week 18
description: SSSQ is a short outcome measure for symptoms and functions. SSSQ consists of 18 questions and three domains including symptom severity, physical function and satisfaction with the degree of treatment. For all these three domains, scores for each domain is calculated by total score of this domain divide the number of answered questions, and if more than two items are missing, the scale scores for this domain are considered missing. The physical function domain assessing walking distance and ability to walk for pleasures, for shopping and for getting around the house or apartment and from bathroom to bedroom has 5 questions with scores ranging from 1 to 4 and higher scores indicating less satisfaction.
measure: The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in physical function domain from baseline
time frame: week 30
description: SSSQ is a short outcome measure for symptoms and functions. SSSQ consists of 18 questions and three domains including symptom severity, physical function and satisfaction with the degree of treatment. For all these three domains, scores for each domain is calculated by total score of this domain divide the number of answered questions, and if more than two items are missing, the scale scores for this domain are considered missing. The physical function domain assessing walking distance and ability to walk for pleasures, for shopping and for getting around the house or apartment and from bathroom to bedroom has 5 questions with scores ranging from 1 to 4 and higher scores indicating less satisfaction.
measure: The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in satisfaction domain from baseline
time frame: week 6
description: SSSQ is a short outcome measure for symptoms and functions. SSSQ consists of 18 questions and three domains including symptom severity, physical function and satisfaction with the degree of treatment. For all these three domains, scores for each domain is calculated by total score of this domain divide the number of answered questions, and if more than two items are missing, the scale scores for this domain are considered missing. The satisfaction domain has four categories (very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied) with a score range of 1 to 4.
measure: The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in satisfaction domain from baseline
time frame: week 18
description: SSSQ is a short outcome measure for symptoms and functions. SSSQ consists of 18 questions and three domains including symptom severity, physical function and satisfaction with the degree of treatment. For all these three domains, scores for each domain is calculated by total score of this domain divide the number of answered questions, and if more than two items are missing, the scale scores for this domain are considered missing. The satisfaction domain has four categories (very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied) with a score range of 1 to 4.
measure: The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in satisfaction domain from baseline
time frame: week 30
description: SSSQ is a short outcome measure for symptoms and functions. SSSQ consists of 18 questions and three domains including symptom severity, physical function and satisfaction with the degree of treatment. For all these three domains, scores for each domain is calculated by total score of this domain divide the number of answered questions, and if more than two items are missing, the scale scores for this domain are considered missing. The satisfaction domain has four categories (very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied) with a score range of 1 to 4.
measure: The proportion of participants with somewhat satisfied in the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
time frame: week 6
description: The proportion of patients with 2 points in the satisfaction domain of SSSQ.
measure: The proportion of participants with somewhat satisfied in the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
time frame: week 18
description: The proportion of patients with 2 points in the satisfaction domain of SSSQ.
measure: The proportion of participants with somewhat satisfied in the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
time frame: week 30
description: The proportion of patients with 2 points in the satisfaction domain of SSSQ.
measure: The proportion of participants with very satisfied based on the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
time frame: week 6
description: The proportion of patients with 1 points in the satisfaction domain of SSSQ.
measure: The proportion of participants with very satisfied based on the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
time frame: week 18
description: The proportion of patients with 1 points in the satisfaction domain of SSSQ.
measure: The proportion of participants with very satisfied based on the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
time frame: week 30
description: The proportion of patients with 1 points in the satisfaction domain of SSSQ.
measure: The change of Hospital Anxiety and Depression Scale (HADS) score from baseline
time frame: week 6
description: HADS is validated and standardized for measuring the state of anxiety and depression. HADS has 2 subscales with 14 items (7 items each), and a total score of 0 to 21 with 0 to 3 for each item.
measure: The change of Hospital Anxiety and Depression Scale (HADS) score from baseline
time frame: week 18
description: HADS is validated and standardized for measuring the state of anxiety and depression. HADS has 2 subscales with 14 items (7 items each), and a total score of 0 to 21 with 0 to 3 for each item.
measure: The change of Hospital Anxiety and Depression Scale (HADS) score from baseline
time frame: week 30
description: HADS is validated and standardized for measuring the state of anxiety and depression. HADS has 2 subscales with 14 items (7 items each), and a total score of 0 to 21 with 0 to 3 for each item.
measure: The proportion of patients who have expectancy of acupuncture
time frame: Baseline
description: Expectancy of acupuncture will be recorded at baseline. Participants will be required to answer two questions: "In general, do you believe acupuncture is effective for treating the illness?" and "Do you think acupuncture will be helpful to improve your symptoms of DLSS?" Participants could choose "Unclear", "Yes" or "No" as the answer.
measure: The proportion of patients with successful blinding
time frame: Week 6
description: Patients will be asked to answer the following questions after treatment (sessions 17 or 18) within 5 minutes: "Do you think you have received traditional acupuncture over the past 6 weeks?" The patients can answer "yes" or "no".
measure: Incidence of adverse events
time frame: week 1 to week 30
description: AEs related to acupuncture include severe pain (assessed by VAS, 7 points at least), broken needle, fainting, local hematoma, localized infection and post-acupuncture discomfortable symptoms such as nausea, vomiting, palpitation, dizziness, headache, anorexia and insomnia, etc. during treatment period. Adverse events irrelevant with the treatment will also be recorded in detail.
arm group label: Acupuncture
arm group type: Experimental
description: The acupoints of Shenshu (BL23), "Dachangshu (BL25)", Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted.
arm group label: Sham acupuncture
arm group type: Sham Comparator
description: The acupoints of Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted into a depth of 2-3mm.
intervention type: Other
intervention name: Acupuncture
description: The acupoints of Shenshu (BL23), "Dachangshu (BL25)", Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted. For the bilateral" BL25", sterile disposable steel needles (Huatuo, Suzhou, China; 0.3 mm×75 mm) will be inserted to a depth of 50-70mm until until participates feel a sensation similar to electric shock radiating downward to the knees. For the other four acupoints (BL23, BL40, BL57 and KI3), the needles (Huatuo, Suzhou, China; 0.3 mm×40 mm) will be inserted to a depth of 15-25 mm, gently rotated three times and lifted to achieve de qi. It should be noted that the needle at KI3 will be inserted at an angle of 45°obliquely downward. There will be 18 treatment sessions with 3 times a week for continuous 6 weeks and a 30 min treatment per session.
arm group label: Acupuncture
intervention type: Other
intervention name: Sham acupuncture
description: The acupoints of Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted into a depth of 2-3mm .No manipulation of needles without deqi will be conducted. The treatment duration and frequency of sessions for participants in the SA group will be the same as in the acupuncture group.
arm group label: Sham acupuncture
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yan Liu, Master
role: Study Director
affiliation: Beijing University of Chinese Medicine
last name: Jing Zhou, Master
phone: 86-010-15650729586
email: zjinbj@sina.com
last name: Zhishun Liu, PhD
phone: 86-010-13651016316
email: zhishunjournal@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
investigator full name: Liu Zhishun
investigator title: Principal Investigator
mesh term: Spinal Stenosis
mesh term: Intermittent Claudication
mesh term: Constriction, Pathologic