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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
196
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.
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.
Guang An Men Hospital
Beijing, China
The Change in Modified Roland-Morris Disability Questionnaire (RMDQ) Score From Baseline
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.
Time frame: week 6
The Change in Modified Roland-Morris Disability Questionnaire (RMDQ) Score From Baseline
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.
Time frame: week 18
The Change in Modified Roland-Morris Disability Questionnaire (RMDQ) Score From Baseline
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.
Time frame: week 30
The Percentage of Participants With at Least 30% Reduction From Baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
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.
Time frame: week 6
The Percentage of Participants With at Least 30% Reduction From Baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
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.
Time frame: week 18
The Percentage of Participants With at Least 30% Reduction From Baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
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.
Time frame: week 30
The Percentage of Participants With at Least 50% Reduction From Baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
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.
Time frame: week 6
The Percentage of Participants With at Least 50% Reduction From Baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
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.
Time frame: week 18
The Percentage of Participants With at Least 50% Reduction From Baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
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.
Time frame: week 30
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
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.
Time frame: week 6
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
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.
Time frame: week 18
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
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.
Time frame: week 30
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
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.
Time frame: week 6
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
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.
Time frame: week 18
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
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.
Time frame: week 30
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
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.
Time frame: week 6
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
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.
Time frame: week 18
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
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.
Time frame: week 30
The Changed Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Symptom Severity Domain From Baseline
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.
Time frame: week 6
The Changed Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Symptom Severity Domain From Baseline
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.
Time frame: week 18
The Changed Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Symptom Severity Domain From Baseline
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.
Time frame: week 30
The Changed Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Physical Function Domain From Baseline
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.
Time frame: week 6
The Changed Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Physical Function Domain From Baseline
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.
Time frame: week 18
The Changed Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Physical Function Domain From Baseline
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.
Time frame: week 30
The Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Satisfaction Domain From Baseline
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.
Time frame: week 6
The Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Satisfaction Domain From Baseline
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.
Time frame: week 18
The Changed Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Satisfaction Domain From Baseline
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.
Time frame: week 30
The Percentage of Participants With Somewhat Satisfied in the Satisfaction Domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
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.
Time frame: week 6
The Percentage of Participants With Somewhat Satisfied in the Satisfaction Domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
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.
Time frame: week 18
The Percentage of Participants With Somewhat Satisfied in the Satisfaction Domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
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.
Time frame: week 30
The Percentage of Participants With Very Satisfied Based on the Satisfaction Domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
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.
Time frame: week 6
The Percentage of Participants With Very Satisfied Based on the Satisfaction Domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
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.
Time frame: week 18
The Percentage of Participants With Very Satisfied Based on the Satisfaction Domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
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.
Time frame: week 30
The Change of Hospital Anxiety and Depression Scale (HADS) Score From Baseline
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.
Time frame: week 6
The Change of Hospital Anxiety and Depression Scale (HADS) Score From Baseline
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.
Time frame: week 18
The Change of Hospital Anxiety and Depression Scale (HADS) Score From Baseline
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.
Time frame: week 30
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