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Efficacy of Acupuncture for Lumbar Spinal Stenosis

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ClinicalTrials.gov Identifier: NCT03784729
Recruitment Status : Not yet recruiting
First Posted : December 24, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Intermittent Claudication Other: Acupuncture Other: Sham acupuncture Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Acupuncture for Intermittent Claudication of Patients With Lumbar Spinal Stenosis
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acupuncture
The acupoints of Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted.
Other: Acupuncture
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 to the capsules of L4 nerve roots. 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, KI13 will be inserted with 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 Comparator: Sham acupuncture
The acupoints of Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted into a depth of 2-3mm.
Other: Sham acupuncture
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 Outcome Measures :
  1. The change score of Modified Roland-Morris Disability Questionnaire (RMDQ) 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 Outcome Measures :
  1. The change score of Modified Roland-Morris Disability Questionnaire (RMDQ) 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 score of Modified Roland-Morris Disability Questionnaire (RMDQ) 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 proportion 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 proportion of patients wtih a reduction of at least 30% from baseline in the RMDQ will be calculated.

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

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

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

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

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

  9. The changed score of pain of buttocks or/and legs when walking, standing or back extending measured by Number Rating Scale (NRS) in the past one 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. The changed score of pain of buttocks or/and legs when walking, standing or back extending measured by Number Rating Scale (NRS) in the past one 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. The changed score of pain of buttocks or/and legs when walking, standing or back extending measured by Number Rating Scale (NRS) in the past one 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. The changed score of pain of lower back when walking, standing or back extending measured by Number Rating Scale (NRS) in the past one 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.

  13. The changed score of pain of lower back when walking, standing or back extending measured by Number Rating Scale (NRS) in the past one 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.

  14. The changed score of pain of lower back when walking, standing or back extending measured by Number Rating Scale (NRS) in the past one 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.

  15. 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. 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.

  16. 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. 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.

  17. 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. 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.

  18. 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. 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.

  19. 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. 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.

  20. 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. 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.

  21. The changed 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. 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.

  22. The changed 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. 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.

  23. 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. 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.

  24. The proportion of participants with somewhat satisfied in the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ) [ Time Frame: week 6 ]
    The proportion of patients with 2 points in the satisfaction domain of SSSQ.

  25. The proportion of participants with somewhat satisfied in the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ) [ Time Frame: week 18 ]
    The proportion of patients with 2 points in the satisfaction domain of SSSQ.

  26. The proportion of participants with somewhat satisfied in the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ) [ Time Frame: week 30 ]
    The proportion of patients with 2 points in the satisfaction domain of SSSQ.

  27. The proportion of participants with very satisfied in the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ) [ Time Frame: week 6 ]
    The proportion of patients with 1 points in the satisfaction domain of SSSQ.

  28. The proportion of participants with very satisfied in the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ) [ Time Frame: week 18 ]
    The proportion of patients with 1 points in the satisfaction domain of SSSQ.

  29. The proportion of participants with very satisfied in the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ) [ Time Frame: week 30 ]
    The proportion of patients with 1 points in the satisfaction domain of SSSQ.

  30. 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. 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.

  31. 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. 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.

  32. 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. 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 Outcome Measures:
  1. The proportion 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 proportion of patients with successful blinding [ Time Frame: Week 6 ]
    Successful blinding was defined as participants who are unclear about which treatment they had taken. Participants will be asked to answer the following questions: "Do you think you have received traditional acupuncture in the past 6 weeks?" after treatment (sessions 17 or 18) within 5 minutes. The participants will be able to choose one answer from the following: "Unclear", "Yes" or "No". Successful blinding was defined as participants who were unclear about which treatment they had been received after treatment.

  3. Incidence of adverse events [ Time Frame: week 1 to week 30 ]
    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.



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants who meet the requirements for a diagnosis of DLSS as well as have central sagittal diameter stenosis of lumbar spinal canal.
  • Neurogenic intermittent claudication (IC) characterized with progressive pain, numbness, weakness and tingling of buttocks or/and legs when standing, walking or with the back extended which relieve on sitting or lying down or bending forward; always walk in flexion or hunchback posture.
  • Have pain of low back, buttocks or/and legs when walking, standing or back extending and the pain which by using the NRS questionnaire is reported ≥4 points in the past one week.
  • Buttock or/and leg pain>low back pain.
  • A Roland-Morris score of at least 7.
  • MRI or CT scan taken within one year showed the anterior posterior diameter of the canal≤ 10mm and the cross section of spinal canal ≤ 70mm.
  • Age 50-80 years.
  • Signed consent and willingness to participate in the trial.

Exclusion Criteria:

  • Congenital stenosis of the vertebral canal, indications of surgery for DLSS (eg, 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 concerning pain and walking function such as fibromyalgia, chronic widespread pain, amputation, stroke, Parkinson's disease, spinal cord injury and dementia.
  • Participants who are cognitively impaired such that they are unable to understand the content of assessment scales or provide accurate data.
  • History of lumbar surgery.
  • Pregnancy or planned pregnancy within 12 months.
  • Acupuncture treatments for DLSS within the past 30 days.
  • Neurogenic intermittent claudication (IC) mainly manifested with numbness, weakness or paresthesia of lower extremities instead of pain.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784729


Contacts
Contact: Jing Zhou, Master 86-010-15650729586 zjinbj@sina.com
Contact: Zhishun Liu, PhD 86-010-13651016316 zhishunjournal@163.com

Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Responsible Party: Liu Zhishun, Principal Investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03784729     History of Changes
Other Study ID Numbers: 2018-161-KY
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Constriction, Pathologic
Intermittent Claudication
Spinal Stenosis
Pathological Conditions, Anatomical
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases