Skip to main content
OpenTrials
Completed

NCT Number: NCT03784729

Efficacy of Acupuncture for Lumbar Spinal Stenosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lumbar Spinal Stenosis Bone Diseases Cardiovascular Diseases Intermittent Claudication Musculoskeletal Diseases Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Spinal Diseases Spinal Stenosis Vascular Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guang An Men Hospital

Beijing, 100053, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet the requirements for a clinical diagnosis of DLSS combined with a MRI- or computed tomography (CT)-based radiological diagnosis of central sagittal diameter stenosis of the lumbar spinal canal;
  • Have neurogenic intermittent claudication (IC) characterized by progressive pain, numbness, weakness, and tingling of the buttocks and/or legs when standing or walking or with extension of the back, which are relieved upon sitting, lying down, or bending forward [22]; they must always walk in flexion or hunchback posture;
  • Have pain of an intensity ≥4 in the buttocks and/or legs when walking, standing, or extending the back, as measured using the Numerical Rating Scale (NRS);
  • Have pain in the buttock and/or leg that is more severe than their pain in the lower back;
  • Have a Roland-Morris score of at least 7;
  • Have received a MRI or CT scan within 1 year that showed the anterior posterior diameter of the canal was ≤12 mm;
  • Are aged 50-80 years;
  • Have provided signed consent and exhibit willingness to participate in the trial.

Exclusion criteria

  • Congenital stenosis of the vertebral canal, indications of surgery for DLSS (e.g., segmental muscular atrophy, bowel and bladder disturbances), spinal instability requiring surgery, lumbar tuberculosis, lumbar metastatic carcinoma, or vertebral body/vertebral stenosis segment compression fracture;
  • Severe vascular, pulmonary, or coronary artery disease with limited lower extremities motility;
  • Clinical comorbidities that could interfere with the collection of data related to pain and walking function such as fibromyalgia, chronic widespread pain, amputation, stroke, Parkinson's disease, spinal cord injury, and dementia;
  • Cognitive impairment, such that they are unable to understand the content of the assessment scales or provide accurate data;
  • A history of lumbar surgery;
  • Plans to become pregnant within 12 months or are already pregnant;
  • Received acupuncture treatments for DLSS within the previous 30 days;
  • Neurogenic IC mainly manifesting as numbness, weakness, or paraesthesia of the lower extremities instead of pain.

Treatment and study plan

Acupuncture

Other

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.

Sham Acupuncture

Other

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.

Primary outcomes

  1. The Change in Modified Roland-Morris Disability Questionnaire (RMDQ) Score From Baseline

    Time frame: week 6

    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.

Secondary outcomes

  1. The Change in Modified Roland-Morris Disability Questionnaire (RMDQ) Score From Baseline

    Time frame: week 18

    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.

  2. The Change in Modified Roland-Morris Disability Questionnaire (RMDQ) Score From Baseline

    Time frame: week 30

    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.

  3. The Percentage of Participants With at Least 30% Reduction From Baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: week 6

    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 percentage of patients wtih a reduction of at least 30% from baseline in the RMDQ will be calculated.

  4. The Percentage of Participants With at Least 30% Reduction From Baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: week 18

    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 percentage of patients wtih a reduction of at least 30% from baseline in the RMDQ will be calculated.

  5. The Percentage of Participants With at Least 30% Reduction From Baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: week 30

    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 percentage of patients wtih a reduction of at least 30% from baseline in the RMDQ will be calculated.

  6. The Percentage of Participants With at Least 50% Reduction From Baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: week 6

    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 percentage of patients wtih a reduction of at least 50% from baseline in the RMDQ will be calculated.

  7. The Percentage of Participants With at Least 50% Reduction From Baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: week 18

    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 percentage of patients wtih a reduction of at least 50% from baseline in the RMDQ will be calculated.

  8. The Percentage of Participants With at Least 50% Reduction From Baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: week 30

    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 percentage of patients wtih a reduction of at least 50% from baseline in the RMDQ will be calculated.

  9. 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

    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.

  10. 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

    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.

  11. 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

    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.

  12. 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

    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.

  13. 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

    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.

  14. 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

    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.

  15. 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

    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.

  16. 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

    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.

  17. 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

    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.

  18. The Changed Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Symptom Severity Domain From Baseline

    Time frame: week 6

    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. The scores for all three domains are calculated by taking the total score for the domain and dividing it by the number of answered questions, and if more than two items are missing, the scale scores for that domain are considered missing.

    Six questions in the symptom severity domain assess pain of the back, buttocks, legs, or feet as well as pain frequency, numbness, and weakness with scores ranging from 1 to 5, while one question assesses balance with possible scores of 1, 3, and 5. The score of symptom severity domain ranges from 1 to 5, with higher scores indicating worse symptoms.

  19. The Changed Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Symptom Severity Domain From Baseline

    Time frame: week 18

    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. The scores for all three domains are calculated by taking the total score for the domain and dividing it by the number of answered questions, and if more than two items are missing, the scale scores for that domain are considered missing.

    Six questions in the symptom severity domain assess pain of the back, buttocks, legs, or feet as well as pain frequency, numbness, and weakness with scores ranging from 1 to 5, while one question assesses balance with possible scores of 1, 3, and 5. The score of symptom severity domain ranges from 1 to 5, with higher scores indicating worse symptoms.

  20. The Changed Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Symptom Severity Domain From Baseline

    Time frame: week 30

    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. The scores for all three domains are calculated by taking the total score for the domain and dividing it by the number of answered questions, and if more than two items are missing, the scale scores for that domain are considered missing.

    Six questions in the symptom severity domain assess pain of the back, buttocks, legs, or feet as well as pain frequency, numbness, and weakness with scores ranging from 1 to 5, while one question assesses balance with possible scores of 1, 3, and 5. The score of symptom severity domain ranges from 1 to 5, with higher scores indicating worse symptoms.

  21. The Changed Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Physical Function Domain From Baseline

    Time frame: week 6

    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. The scores for all three domains are calculated by taking the total score for the domain and dividing it by the number of answered questions, and if more than two items are missing, the scale scores for that domain are considered missing.

    The physical function domain assesses walking distance and ability to walk for pleasure, shopping, and getting around the house or apartment and from the bathroom to the bedroom. This domain has five questions with scores ranging from 1 to 4, and higher scores indicate worse function.

  22. The Changed Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Physical Function Domain From Baseline

    Time frame: week 18

    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. The scores for all three domains are calculated by taking the total score for the domain and dividing it by the number of answered questions, and if more than two items are missing, the scale scores for that domain are considered missing.

    The physical function domain assesses walking distance and ability to walk for pleasure, shopping, and getting around the house or apartment and from the bathroom to the bedroom. This domain has five questions with scores ranging from 1 to 4, and higher scores indicate worse function.

  23. The Changed Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Physical Function Domain From Baseline

    Time frame: week 30

    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. The scores for all three domains are calculated by taking the total score for the domain and dividing it by the number of answered questions, and if more than two items are missing, the scale scores for that domain are considered missing.

    The physical function domain assesses walking distance and ability to walk for pleasure, shopping, and getting around the house or apartment and from the bathroom to the bedroom. This domain has five questions with scores ranging from 1 to 4, and higher scores indicate worse function.

  24. The Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Satisfaction Domain From Baseline

    Time frame: week 6

    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. The scores for all three domains are calculated by taking the total score for the domain and dividing it by the number of answered questions, and if more than two items are missing, the scale scores for that 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.

  25. The Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Satisfaction Domain From Baseline

    Time frame: week 18

    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. The scores for all three domains are calculated by taking the total score for the domain and dividing it by the number of answered questions, and if more than two items are missing, the scale scores for that 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.

  26. The Changed Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Satisfaction Domain From Baseline

    Time frame: week 30

    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. The scores for all three domains are calculated by taking the total score for the domain and dividing it by the number of answered questions, and if more than two items are missing, the scale scores for that 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.

  27. The Percentage of Participants With Somewhat Satisfied in the Satisfaction Domain of Swiss Spinal Stenosis Questionnaire (SSSQ)

    Time frame: week 6

    According to satisfaction domain of the SSSQ, patients scoring 1.5-2.5 points are regarded as somewhat satisfied with the therapy, and those scoring 1.5 points or lower are regarded as very satisfied with the therapy.

  28. The Percentage of Participants With Somewhat Satisfied in the Satisfaction Domain of Swiss Spinal Stenosis Questionnaire (SSSQ)

    Time frame: week 18

    According to satisfaction domain of the SSSQ, patients scoring 1.5-2.5 points are regarded as somewhat satisfied with the therapy, and those scoring 1.5 points or lower are regarded as very satisfied with the therapy.

  29. The Percentage of Participants With Somewhat Satisfied in the Satisfaction Domain of Swiss Spinal Stenosis Questionnaire (SSSQ)

    Time frame: week 30

    According to satisfaction domain of the SSSQ, patients scoring 1.5-2.5 points are regarded as somewhat satisfied with the therapy, and those scoring 1.5 points or lower are regarded as very satisfied with the therapy.

  30. The Percentage of Participants With Very Satisfied Based on the Satisfaction Domain of Swiss Spinal Stenosis Questionnaire (SSSQ)

    Time frame: week 6

    According to satisfaction domain of the SSSQ, patients scoring 1.5-2.5 points are regarded as somewhat satisfied with the therapy, and those scoring 1.5 points or lower are regarded as very satisfied with the therapy.

  31. The Percentage of Participants With Very Satisfied Based on the Satisfaction Domain of Swiss Spinal Stenosis Questionnaire (SSSQ)

    Time frame: week 18

    According to satisfaction domain of the SSSQ, patients scoring 1.5-2.5 points are regarded as somewhat satisfied with the therapy, and those scoring 1.5 points or lower are regarded as very satisfied with the therapy.

  32. The Percentage of Participants With Very Satisfied Based on the Satisfaction Domain of Swiss Spinal Stenosis Questionnaire (SSSQ)

    Time frame: week 30

    According to satisfaction domain of the SSSQ, patients scoring 1.5-2.5 points are regarded as somewhat satisfied with the therapy, and those scoring 1.5 points or lower are regarded as very satisfied with the therapy.

  33. The Change of Hospital Anxiety and Depression Scale (HADS) Score From Baseline

    Time frame: week 6

    HADS is validated and standardized for measuring the state of anxiety and depression (0-42, with higher scores indicating severe symptoms). 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.

  34. The Change of Hospital Anxiety and Depression Scale (HADS) Score From Baseline

    Time frame: week 18

    HADS is validated and standardized for measuring the state of anxiety and depression (0-42, with higher scores indicating severe symptoms). 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.

  35. The Change of Hospital Anxiety and Depression Scale (HADS) Score From Baseline

    Time frame: week 30

    HADS is validated and standardized for measuring the state of anxiety and depression (0-42, with higher scores indicating severe symptoms). 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.

Other outcomes

  1. The Percentage of Patients Who Have Expectancy of Acupuncture

    Time frame: Baseline

    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.

  2. The Percentage of Patients With Successful Blinding

    Time frame: Week 6

    Patients will be informed that the study involves two types of acupuncture: traditional and modern. Following treatment (sessions 17 or 18) and within 5 minutes, they will be asked: 'Based on your experience, which acupuncture type do you think you received: traditional or modern?' Successful blinding will be defined as the patient indicating they received 'traditional' acupuncture.

  3. Number of Participants With Adverse Events

    Time frame: week 1 to week 30

    Adverse events 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.

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Official study title

Efficacy of Acupuncture for Intermittent Claudication of Patients With Lumbar Spinal Stenosis

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Dec 24, 2018
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.