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Efficacy of Acupuncture for Lumbar Spinal Stenosis

Primary Purpose

Lumbar Spinal Stenosis, Intermittent Claudication

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture
Sham acupuncture
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guang An Men HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Acupuncture

Sham acupuncture

Arm Description

The acupoints of Shenshu (BL23), "Dachangshu (BL25)", Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted.

The acupoints of Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted into a depth of 2-3mm.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
The proportion 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 proportion of patients wtih a reduction of at least 30% from baseline in the RMDQ will be calculated.
The proportion 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 proportion of patients wtih a reduction of at least 30% from baseline in the RMDQ will be calculated.
The proportion 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 proportion of patients wtih a reduction of at least 30% from baseline in the RMDQ will be calculated.
The proportion 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 proportion of patients wtih a reduction of at least 50% from baseline in the RMDQ will be calculated.
The proportion 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 proportion of patients wtih a reduction of at least 50% from baseline in the RMDQ will be calculated.
The proportion 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 proportion of patients wtih a reduction of at least 50% from baseline in the RMDQ will be calculated.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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. 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.
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. 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.
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. 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.
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. 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.
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. 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.
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. 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.
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. 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.
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. 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.
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. 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.
The proportion of participants with somewhat satisfied in the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
The proportion of patients with 2 points in the satisfaction domain of SSSQ.
The proportion of participants with somewhat satisfied in the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
The proportion of patients with 2 points in the satisfaction domain of SSSQ.
The proportion of participants with somewhat satisfied in the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
The proportion of patients with 2 points in the satisfaction domain of SSSQ.
The proportion of participants with very satisfied based on the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
The proportion of patients with 1 points in the satisfaction domain of SSSQ.
The proportion of participants with very satisfied based on the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
The proportion of patients with 1 points in the satisfaction domain of SSSQ.
The proportion of participants with very satisfied based on the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
The proportion of patients with 1 points in the satisfaction domain of SSSQ.
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. 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.
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. 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.
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. 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.

Full Information

First Posted
December 17, 2018
Last Updated
July 21, 2020
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03784729
Brief Title
Efficacy of Acupuncture for Lumbar Spinal Stenosis
Official Title
Efficacy of Acupuncture for Intermittent Claudication of Patients With Lumbar Spinal Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis, Intermittent Claudication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
The acupoints of Shenshu (BL23), "Dachangshu (BL25)", Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted.
Arm Title
Sham acupuncture
Arm Type
Sham Comparator
Arm 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(s)
Acupuncture
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Sham acupuncture
Intervention 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.
Primary Outcome Measure Information:
Title
The change in Modified Roland-Morris Disability Questionnaire (RMDQ) score from baseline
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.
Time Frame
week 6
Secondary Outcome Measure Information:
Title
The change in Modified Roland-Morris Disability Questionnaire (RMDQ) score from baseline
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.
Time Frame
week 18
Title
The change in Modified Roland-Morris Disability Questionnaire (RMDQ) score from baseline
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.
Time Frame
week 30
Title
The proportion of participants with at least 30% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
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.
Time Frame
week 6
Title
The proportion of participants with at least 30% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
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.
Time Frame
week 18
Title
The proportion of participants with at least 30% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
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.
Time Frame
week 30
Title
The proportion of participants with at least 50% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
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.
Time Frame
week 6
Title
The proportion of participants with at least 50% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
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.
Time Frame
week 18
Title
The proportion of participants with at least 50% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
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.
Time Frame
week 30
Title
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
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.
Time Frame
week 6
Title
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
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.
Time Frame
week 18
Title
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
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.
Time Frame
week 30
Title
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
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.
Time Frame
week 6
Title
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
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.
Time Frame
week 18
Title
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
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.
Time Frame
week 30
Title
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
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.
Time Frame
week 6
Title
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
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.
Time Frame
week 18
Title
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
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.
Time Frame
week 30
Title
The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in symptom severity domain from baseline
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.
Time Frame
week 6
Title
The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in symptom severity domain from baseline
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.
Time Frame
week 18
Title
The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in symptom severity domain from baseline
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.
Time Frame
week 30
Title
The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in physical function domain from baseline
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.
Time Frame
week 6
Title
The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in physical function domain from baseline
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.
Time Frame
week 18
Title
The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in physical function domain from baseline
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.
Time Frame
week 30
Title
The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in satisfaction domain from baseline
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.
Time Frame
week 6
Title
The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in satisfaction domain from baseline
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.
Time Frame
week 18
Title
The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in satisfaction domain from baseline
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.
Time Frame
week 30
Title
The proportion of participants with somewhat satisfied in the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
Description
The proportion of patients with 2 points in the satisfaction domain of SSSQ.
Time Frame
week 6
Title
The proportion of participants with somewhat satisfied in the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
Description
The proportion of patients with 2 points in the satisfaction domain of SSSQ.
Time Frame
week 18
Title
The proportion of participants with somewhat satisfied in the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
Description
The proportion of patients with 2 points in the satisfaction domain of SSSQ.
Time Frame
week 30
Title
The proportion of participants with very satisfied based on the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
Description
The proportion of patients with 1 points in the satisfaction domain of SSSQ.
Time Frame
week 6
Title
The proportion of participants with very satisfied based on the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
Description
The proportion of patients with 1 points in the satisfaction domain of SSSQ.
Time Frame
week 18
Title
The proportion of participants with very satisfied based on the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
Description
The proportion of patients with 1 points in the satisfaction domain of SSSQ.
Time Frame
week 30
Title
The change of Hospital Anxiety and Depression Scale (HADS) score from baseline
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.
Time Frame
week 6
Title
The change of Hospital Anxiety and Depression Scale (HADS) score from baseline
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.
Time Frame
week 18
Title
The change of Hospital Anxiety and Depression Scale (HADS) score from baseline
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.
Time Frame
week 30
Other Pre-specified Outcome Measures:
Title
The proportion of patients who have expectancy of acupuncture
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.
Time Frame
Baseline
Title
The proportion of patients with successful blinding
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".
Time Frame
Week 6
Title
Incidence of adverse events
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.
Time Frame
week 1 to week 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Zhou, Master
Phone
86-010-15650729586
Email
zjinbj@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhishun Liu, PhD
Phone
86-010-13651016316
Email
zhishunjournal@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Liu, Master
Organizational Affiliation
Beijing University of Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Guang An Men Hospital
City
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruiming Jiao, Master
Phone
8610-88002331
Email
18801247843@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
32711555
Citation
Zhou J, Liu S, Sun Y, Wang W, Liu Z. Efficacy of acupuncture for treatment of intermittent claudication in patients with degenerative lumbar spinal stenosis: protocol for a randomized controlled trial. Trials. 2020 Jul 25;21(1):679. doi: 10.1186/s13063-020-04612-8.
Results Reference
derived

Learn more about this trial

Efficacy of Acupuncture for Lumbar Spinal Stenosis

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