Efficacy of Acupuncture for Lumbar Spinal Stenosis

Lumbar Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03784729
• Other study ID #: 2018-161-KY
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2020
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Jing Zhou, Master
• Phone: 86-010-15650729586
• Email: zjinbj[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: December 31, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Intermittent Claudication
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

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 until participates feel a sensation similar to electric shock radiating downward to the knees. For the other four acupoints (BL23, BL40, BL57 and KI3), the needles (Huatuo, Suzhou, China; 0.3 mm×40 mm) will be inserted to a depth of 15-25 mm, gently rotated three times and lifted to achieve de qi. It should be noted that the needle at KI3 will be inserted at an angle of 45°obliquely downward. There will be 18 treatment sessions with 3 times a week for continuous 6 weeks and a 30 min treatment per session.
• Sham acupuncture
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.

Locations

Country	Name	City	State
China	Guang An Men Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The proportion of patients who have expectancy of acupuncture	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.	Baseline
Other	The proportion of patients with successful blinding	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".	Week 6
Other	Incidence of adverse events	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.	week 1 to week 30
Primary	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.	week 6
Secondary	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.	week 18
Secondary	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.	week 30
Secondary	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.	week 6
Secondary	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.	week 18
Secondary	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.	week 30
Secondary	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.	week 6
Secondary	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.	week 18
Secondary	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.	week 30
Secondary	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.	week 6
Secondary	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.	week 18
Secondary	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.	week 30
Secondary	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.	week 6
Secondary	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.	week 18
Secondary	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.	week 30
Secondary	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.	week 6
Secondary	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.	week 18
Secondary	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.	week 30
Secondary	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.	week 6
Secondary	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.	week 18
Secondary	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.	week 30
Secondary	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.	week 6
Secondary	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.	week 18
Secondary	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.	week 30
Secondary	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.	week 6
Secondary	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.	week 18
Secondary	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.	week 30
Secondary	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.	week 6
Secondary	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.	week 18
Secondary	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.	week 30
Secondary	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.	week 6
Secondary	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.	week 18
Secondary	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.	week 30
Secondary	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.	week 6
Secondary	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.	week 18
Secondary	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.	week 30