Lumbar Spinal StenosisNCT03784729

Efficacy of Acupuncture for Lumbar Spinal Stenosis

A study testing Acupuncture in people with Lumbar Spinal Stenosis and Intermittent Claudication, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 to 80 years
Conditions the study is for: Lumbar Spinal Stenosis, Intermittent Claudication
What is being tested?: Acupuncture
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 196 participants
Where: 1 siteChina
Study dates: 25 Mar 2019to 18 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Guang An Men Hospital
Beijing, 100053

Other trials in China

About this study

Official title: Efficacy of Acupuncture for Intermittent Claudication of Patients With Lumbar Spinal Stenosis

Degenerative lumbar spinal stenosis (DLSS) is a condition which there is narrowing space of sagittal diameter of spinal canal or nerve root canal for spinal nerve or cauda equina secondary to degenerative changes. DLSS is a common cause of gluteal or lower extremity pain, women and elderly people aged 60-70 are more likely to have DLSS. The early symptoms of this disease are soreness and pain in the low back, gluteal region and posterior region of thighs which can be relieved after resting or changing posture. Being accompanied with gradually aggravated symptoms, patients with DLSS may have neurogenic claudication with hypoesthesia and numbness in lateral lower legs and feet, additionally, few patients may have bowel and bladder disturbances. In accordance of the guidelines of North American Spine Society (NASS), treatment options comprise surgical therapy, epidural steroid injections and physical therapy and transcutaneous electrical stimulation, however, the long-term efficacy of surgery is not superior to that of non-surgical therapy. Moreover, the short-term efficacy of non-surgical therapy is with insufficient evidence. According to a systematic review and recent studies, acupuncture may improve the symptoms of patients and their quality of life, however, there is a lack of placebo-controlled and large sample sized study.

Conditions: Lumbar Spinal Stenosis, Intermittent Claudication
Being tested: Acupuncture, Sham acupuncture
Medical subject headings: Spinal Stenosis, Intermittent Claudication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcupunctureOther
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 acupunctureOther
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.

Study groups in NCT03784729
Study group	Role	What they receive
Acupuncture	Experimental	The acupoints of Shenshu (BL23), "Dachangshu (BL25)", Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted. Receives: Other: Acupuncture
Sham acupuncture	Sham comparator	The acupoints of Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted into a depth of 2-3mm. Receives: Other: Sham acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: week 6

Secondary outcomes (35)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Mar 201918 Mar 2022

First posted24 Dec 2018
Study start25 Mar 2019
Primary completion1 Oct 2021
Study completion18 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 196 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03784729
Sponsor's protocol ID: 2018-161-KY
Status last verified: Aug 2025
First submitted: 17 Dec 2018
Last updated: 20 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Zhu L, Sun Y, Kang J, Liang J, Su T, Fu W, Zhang W, Dai R, Hou Y, Zhao H, Peng W, Wang W, Zhou J, Jiao R, Sun B, Yan Y, Liu Y, Liu Z. Effect of Acupuncture on Neurogenic Claudication Among Patients With Degenerative Lumbar Spinal Stenosis : A Randomized Clinical Trial. Ann Intern Med. 2024 Aug;177(8):1048-1057. doi: 10.7326/M23-2749. Epub 2024 Jul 2.
PubMed 38950397
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.
PubMed 32711555

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
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Recruiting
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All Lumbar Spinal Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Acupuncture for Intermittent Claudication of Patients With Lumbar Spinal Stenosis
ClinicalTrials.gov ID: NCT03784729
Acronym / sponsor ID: 2018-161-KY
Conditions: Lumbar Spinal Stenosis, Intermittent Claudication
Study type: Interventional
Recruitment status: Completed
Enrolment: 196 participants (actual)
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
Study start: 25 Mar 2019 (actual)
Primary completion: 1 Oct 2021 (actual)
Study completion: 18 Mar 2022 (actual)
First posted: 24 Dec 2018 (actual)
Results: Posted 20 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Acupuncture	Experimental	Other: AcupunctureThe acupoints of Shenshu (BL23), "Dachangshu (BL25)", Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted.
Sham acupuncture	Sham comparator	Other: Sham acupunctureThe acupoints of Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted into a depth of 2-3mm.

Who may qualify

Ages: 50 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AcupunctureThe 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.	Other	Acupuncture
Sham acupunctureThe 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.	Other	Sham acupuncture

Primary outcome

The Change in Modified Roland-Morris Disability Questionnaire (RMDQ) Score From Baseline
Time frame: week 6
Modified Roland-Morris Disability Questionnaire (RMDQ) is a reliable pain-specific functional status questionnaire which is easy and simple for patients to complete. The RMDQ includes 24 questions with a score range of 0-24, and there is a phrase "caused by low back pain" after each question which could excluded other reasons for dysfunction of the back. For this scale, higher scores indicate more severe symptoms.

35 secondary outcomes

The Change in Modified Roland-Morris Disability Questionnaire (RMDQ) Score From Baseline
Time frame: week 18
The Change in Modified Roland-Morris Disability Questionnaire (RMDQ) Score From Baseline
Time frame: week 30
The Percentage of Participants With at Least 30% Reduction From Baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
Time frame: week 6
The Percentage of Participants With at Least 30% Reduction From Baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
Time frame: week 18
The Percentage of Participants With at Least 30% Reduction From Baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
Time frame: week 30
The Percentage of Participants With at Least 50% Reduction From Baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
Time frame: week 6
The Percentage of Participants With at Least 50% Reduction From Baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
Time frame: week 18
The Percentage of Participants With at Least 50% Reduction From Baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
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
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
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
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
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
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
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
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
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
Time frame: week 30
The Changed Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Symptom Severity Domain From Baseline
Time frame: week 6
The Changed Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Symptom Severity Domain From Baseline
Time frame: week 18
The Changed Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Symptom Severity Domain From Baseline
Time frame: week 30
The Changed Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Physical Function Domain From Baseline
Time frame: week 6
The Changed Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Physical Function Domain From Baseline
Time frame: week 18
The Changed Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Physical Function Domain From Baseline
Time frame: week 30
The Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Satisfaction Domain From Baseline
Time frame: week 6
The Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Satisfaction Domain From Baseline
Time frame: week 18
The Changed Mean Score of Swiss Spinal Stenosis Questionnaire (SSSQ) in Satisfaction Domain From Baseline
Time frame: week 30
The Percentage of Participants With Somewhat Satisfied in the Satisfaction Domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
Time frame: week 6
The Percentage of Participants With Somewhat Satisfied in the Satisfaction Domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
Time frame: week 18
The Percentage of Participants With Somewhat Satisfied in the Satisfaction Domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
Time frame: week 30
The Percentage of Participants With Very Satisfied Based on the Satisfaction Domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
Time frame: week 6
The Percentage of Participants With Very Satisfied Based on the Satisfaction Domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
Time frame: week 18
The Percentage of Participants With Very Satisfied Based on the Satisfaction Domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
Time frame: week 30
The Change of Hospital Anxiety and Depression Scale (HADS) Score From Baseline
Time frame: week 6
The Change of Hospital Anxiety and Depression Scale (HADS) Score From Baseline
Time frame: week 18
The Change of Hospital Anxiety and Depression Scale (HADS) Score From Baseline
Time frame: week 30

Results and safety

Results posted to the registry on 20 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acupuncture	98	86
Sham Acupuncture	98	88

Primary outcome: The Change in Modified Roland-Morris Disability Questionnaire (RMDQ) Score From Baseline

Time frame: week 6. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Acupuncture n = 87	Sham Acupuncture n = 91
Value	-4.3 (-5.2 to -3.4)	-3.0 (-3.9 to -2.1)

35 secondary outcomes are reported in the full results.

Adverse events

Time frame: 31 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acupuncture	3 of 98 (3.1%)	6 of 98 (6.1%)	0 of 98
Sham Acupuncture	1 of 98 (1%)	2 of 98 (2%)	0 of 98

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38950397Zhu L, Sun Y, Kang J, Liang J, Su T, Fu W, Zhang W, Dai R, Hou Y, Zhao H, Peng W, Wang W, Zhou J, Jiao R, Sun B, Yan Y, Liu Y, Liu Z. Effect of Acupuncture on Neurogenic Claudication Among Patients With Degenerative Lumbar Spinal Stenosis : A Randomized Clinical Trial. Ann Intern Med. 2024 Aug;177(8):1048-1057. doi: 10.7326/M23-2749. Epub 2024 Jul 2.
Derived from this study: PubMed 32711555Zhou 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yan Liu, Master study director

Beijing University of Chinese Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture in people with Lumbar Spinal Stenosis and Intermittent Claudication, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Change in Modified Roland-Morris Disability Questionnaire (RMDQ) Score From Baseline (time frame: week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03784729, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.