Lumbar Spinal StenosisNCT06102798
Acupuncture for Lumbar Spinal Stenosis
A study testing Acunpuncture in people with Lumbar Spinal Stenosis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
The clinical trial aims to evaluate the efficacy and safety of acupuncture in alleviating neurogenic claudication symptoms among patients with degenerative lumbar spinal stenosis (LSS). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Acunpuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 diagnosis criteria of LSS;
- Aged between 50-80 years;
- Neurogenic claudication (NC) for more than 3 months;
- Able to walk for at least 20 meters continually without device assistance, and forced to stopped walking out of NC within 30 mins in the meanwhile;
- The average pain of buttocks and/or legs scores≥4 on the Numerical Rating Scale (NRS) when walking, standing, or extending the back in the past week;
- More severe pain in the buttock and/or leg than in the lower back;
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- Score at least 7 on Modified Roland-Morris Disability Questionnaire（RMDQ）;
- Central sagittal diameter stenosis of lumbar spinal canal as manifested by MRI or CT scan;
- Volunteer to participate the trial and provide written informed consent.
Who cannot join
- Non-degenerative LSS, such as congenital, post-traumatic or spondylolisthesis LSS; operation indications, such as segmental muscular atrophy, bowel and bladder disfunction, and spinal instability; tuberculosis or tumor in the lumbar area; or multiple vertebral compression fracture or compression fracture in the segment of stenosis;
- Vascular claudication;
- Severe heart, pulmonary, liver and/or kidney diseases;
- Clinical comorbidities that may interfere with the assessment of pain intensity or walking ability, such as fibromyalgia, chronic widespread pain, amputation, stroke, Parkinson's disease, spinal cord injury, severe diabetes, and severe hypertension etc;
- Unable to complete motorized treadmill test at the speed of 2km/h;
- Severe psychiatric disorder or cognitive impairment that prevent the understanding of the outcome evaluating questionnaires;
- A history of lumbar surgery;
- Have received acupuncture treatments in the previous 2 weeks;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing
Zhishun Liu, +861088002331, zhishunjournal@163.com
About this study
Official title: The Efficacy and Safety of Acupuncture in Relieving Neurogenic Claudication Among Patients With Lumbar Spinal Stenosis: a Randomized Controlled Trial
The clinical trial aims to evaluate the efficacy and safety of acupuncture in alleviating neurogenic claudication symptoms among patients with degenerative lumbar spinal stenosis (LSS).
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Acunpuncture, Sham acupuncture
- Keywords
- Acupuncture, Neurogenic Claudication, Randomized controlled trial, Lumbar Spinal Stenosis
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcunpunctureDevice
For the bilateral" BL25", sterile disposable steel needles (Hwato, China; 0.3 mm×75 mm) will be inserted through adhesive pads to a depth of 50-70mm 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 (Hwato, China; 0.3 mm×40 mm) will be inserted through adhesive pads to a depth of 15-25 mm, gently rotated three times and lifted to achieve de qi.
Sham acupunctureDevice
For all the points, the needles will be inserted into adhesive pads without skin penetration. Needles will be lifted, thrust and twirled for 3 times to mimic real acupuncture. No manipulation will be conducted during 30-minute maintenance.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Hwato brand disposable acupuncture needles and adhesive pads will be used. The acupoints of Shenshu (BL23), "Dachangshu (BL25)", Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted. There will be 18 treatment sessions with 3 times a week for continuous 6 weeks and a 30 min treatment per session. Receives: Device: Acunpuncture |
| Sham acupuncture | Sham comparator | Hwato brand disposable placebo needles (with the handle identical to the needles in the acupuncture group and the body at a size 0.30 × 25 mm) and adhesive pads will be used. The acupoints of Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be selected. The treatment duration and frequency of sessions for participants in the SA group will be the same as in the acupuncture group. Receives: Device: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants who achieves at least 30% improvement in total walking distance from baseline.
The total walking distance is defined as the distance that participants forced to stop due to symptoms of neurogenic claudication or a time limit of 30 minutes during the motorized treadmill test (MTT).
Measured: Weeks 6 and 18
Secondary outcomes (14)
The proportion of participants who have at least 50% reduction from baseline in the average scores of buttocks and/or legs pain when walking, standing, or extending the back in the past week as measured by the Number Rating Scale (NRS).
Number Rating Scale (NRS) is a brief scale 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 minimum value is 0 points, and the maximum value is 10 points. The higher the score, the worse the result.
Measured: Weeks 6,18 and 30
The proportion of participants who achieved at least 50% improvement in total walking distance from baseline.
The total walking distance is defined as the distance that participants forced to stop due to symptoms of neurogenic claudication or a time limit of 30 minutes during the MTT.
Measured: Weeks 6 and 18
The change in total walking distance from baseline.
The total walking distance is defined as the distance that participants forced to stop due to symptoms of neurogenic claudication or a time limit of 30 minutes during the MTT.
Measured: Weeks 6 and 18
The change in the time to first symptoms from baseline.
The time to first symptoms refers to the time when one or both legs experience pain, fatigue, abnormal sensations, and/or tightness during the MTT.
Measured: Weeks 6 and 18
The change in the time to first moderate pain symptom from baseline.
The first moderate pain symptom refers to NRS score ≥4. Number Rating Scale (NRS) is a brief scale 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 minimum value is 0 points, and the maximum value is 10 points. The higher the score, the worse the result.
Measured: Weeks 6 and 18
The change in final pain intensity from baseline.
When the subject reached their maximum distance, they were asked their NRS score, this was recorded as final pain intensity. Number Rating Scale (NRS) is a brief scale 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 minimum value is 0 points, and the maximum value is 10 points. The higher the score, the worse the result.
Measured: Weeks 6 and 18
The change in recovery time from baseline.
Recovery time refers to time to return to baseline pain intensity after MTT.
Measured: Weeks 6 and 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. higher scores indicate more severe symptoms.
Measured: Weeks 6,18 and 30
Changes from baseline in the average score of buttocks and/or legs pain when walking, standing, or extending the back as measured by the NRS in the previous 1 week.
Number Rating Scale (NRS) is a brief scale 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 minimum value is 0 points, and the maximum value is 10 points. The higher the score, the worse the result.
Measured: Weeks 6,18 and 30
Changes in the average score of lower back pain when walking, standing, or extending the back as measured by the NRS in the previous 1 week from baseline.
Number Rating Scale (NRS) is a brief scale 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 minimum value is 0 points, and the maximum value is 10 points. The higher the score, the worse the result.
Measured: Weeks 6,18 and 30
The change from baseline in the index score of European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L).
The European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L) includes five dimensions: Mobility, Self Care, Usual Activities, Pain or Discomfort, and Anxiety or Depression. Each dimension also includes five levels: no difficulty, slight difficulty, moderate difficulty, severe difficulty, and extreme difficulty. Each dimension has a high score of 5 and a low score of 1. The EQ-5D-5L index score can be calculated based on the choices made by the respondents on the five dimensions and five levels in the questionnaire.
Measured: Weeks 6,18 and 30
The change from baseline in the domain scores (symptom severity and physical function) of Swiss Spinal Stenosis Questionnaire (SSSQ).
SSSQ include three domains, which are symptom severity, physical function and satisfaction with the treatment. 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 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 less satisfaction. For satisfactory domain, patients scoring 2.5 points or less are regarded as satisfied with the treatment.
Measured: Weeks 6,18 and 30
The proportion of participants who are satisfied with the treatment based on the satisfaction domain of the SSSQ.
SSSQ include three domains, which are symptom severity, physical function and satisfaction with the treatment. 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 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 less satisfaction. For satisfactory domain, patients scoring 2.5 points or less are regarded as satisfied with the treatment.
Measured: Weeks 6,18 and 30
The change from baseline in the total score of Hospital Anxiety and Depression Scale (HADS).
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.
Measured: Weeks 6,18 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start14 Nov 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, PhD, Study chair, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102798
- Sponsor's protocol ID
- 2023-039-KY-01
- Status last verified
- Oct 2023
- First submitted
- 22 Oct 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Acupuncture in Relieving Neurogenic Claudication Among Patients With Lumbar Spinal Stenosis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06102798
- Acronym / sponsor ID
- 2023-039-KY-01
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Acupuncture, Neurogenic Claudication, Randomized controlled trial, Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The clinical trial aims to evaluate the efficacy and safety of acupuncture in alleviating neurogenic claudication symptoms among patients with degenerative lumbar spinal stenosis (LSS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Device: AcunpunctureHwato brand disposable acupuncture needles and adhesive pads will be used. The acupoints of Shenshu (BL23), "Dachangshu (BL25)", Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted. There will be 18 treatment sessions with 3 times a week for continuous 6 weeks and a 30 min treatment per session. |
| Sham acupuncture | Sham comparator | Device: Sham acupunctureHwato brand disposable placebo needles (with the handle identical to the needles in the acupuncture group and the body at a size 0.30 × 25 mm) and adhesive pads will be used. The acupoints of Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be selected. The treatment duration and frequency of sessions for participants in the SA group will be the same as in the acupuncture group. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Meet the diagnosis criteria of LSS;
- Aged between 50-80 years;
- Neurogenic claudication (NC) for more than 3 months;
- Able to walk for at least 20 meters continually without device assistance, and forced to stopped walking out of NC within 30 mins in the meanwhile;
- The average pain of buttocks and/or legs scores≥4 on the Numerical Rating Scale (NRS) when walking, standing, or extending the back in the past week;
Key exclusion criteria (8 listed)
- Non-degenerative LSS, such as congenital, post-traumatic or spondylolisthesis LSS; operation indications, such as segmental muscular atrophy, bowel and bladder disfunction, and spinal instability; tuberculosis or tumor in the lumbar area; or multiple vertebral compression fracture or compression fracture in the segment of stenosis;
- Vascular claudication;
- Severe heart, pulmonary, liver and/or kidney diseases;
- Clinical comorbidities that may interfere with the assessment of pain intensity or walking ability, such as fibromyalgia, chronic widespread pain, amputation, stroke, Parkinson's disease, spinal cord injury, severe diabetes, and severe hypertension etc;
- Unable to complete motorized treadmill test at the speed of 2km/h;
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 |
|---|---|---|
| AcunpunctureFor the bilateral" BL25", sterile disposable steel needles (Hwato, China; 0.3 mm×75 mm) will be inserted through adhesive pads to a depth of 50-70mm 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 (Hwato, China; 0.3 mm×40 mm) will be inserted through adhesive pads to a depth of 15-25 mm, gently rotated three times and lifted to achieve de qi. | Device | Acupuncture |
| Sham acupunctureFor all the points, the needles will be inserted into adhesive pads without skin penetration. Needles will be lifted, thrust and twirled for 3 times to mimic real acupuncture. No manipulation will be conducted during 30-minute maintenance. | Device | Sham acupuncture |
Primary outcome
The proportion of participants who achieves at least 30% improvement in total walking distance from baseline.
Time frame: Weeks 6 and 18
The total walking distance is defined as the distance that participants forced to stop due to symptoms of neurogenic claudication or a time limit of 30 minutes during the motorized treadmill test (MTT).
14 secondary outcomes
The proportion of participants who have at least 50% reduction from baseline in the average scores of buttocks and/or legs pain when walking, standing, or extending the back in the past week as measured by the Number Rating Scale (NRS).
Time frame: Weeks 6,18 and 30
The proportion of participants who achieved at least 50% improvement in total walking distance from baseline.
Time frame: Weeks 6 and 18
The change in total walking distance from baseline.
Time frame: Weeks 6 and 18
The change in the time to first symptoms from baseline.
Time frame: Weeks 6 and 18
The change in the time to first moderate pain symptom from baseline.
Time frame: Weeks 6 and 18
The change in final pain intensity from baseline.
Time frame: Weeks 6 and 18
The change in recovery time from baseline.
Time frame: Weeks 6 and 18
The change in Modified Roland-Morris Disability Questionnaire (RMDQ) score from baseline.
Time frame: Weeks 6,18 and 30
Changes from baseline in the average score of buttocks and/or legs pain when walking, standing, or extending the back as measured by the NRS in the previous 1 week.
Time frame: Weeks 6,18 and 30
Changes in the average score of lower back pain when walking, standing, or extending the back as measured by the NRS in the previous 1 week from baseline.
Time frame: Weeks 6,18 and 30
The change from baseline in the index score of European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L).
Time frame: Weeks 6,18 and 30
The change from baseline in the domain scores (symptom severity and physical function) of Swiss Spinal Stenosis Questionnaire (SSSQ).
Time frame: Weeks 6,18 and 30
The proportion of participants who are satisfied with the treatment based on the satisfaction domain of the SSSQ.
Time frame: Weeks 6,18 and 30
The change from baseline in the total score of Hospital Anxiety and Depression Scale (HADS).
Time frame: Weeks 6,18 and 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
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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.
Zhishun Liu, PhD study chair
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acunpuncture in people with Lumbar Spinal Stenosis, 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 9 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: status not confirmed, as of the sponsor's last update on 11 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhishun Liu, PhD (86-010-88002331, zhishunjournal@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants who achieves at least 30% improvement in total walking distance from baseline. (time frame: Weeks 6 and 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2024.