Acupuncture for Lumbar Spinal Stenosis

January 9, 2024 updated by: Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
420

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Meet the diagnosis criteria of LSS;
  2. Aged between 50-80 years;
  3. Neurogenic claudication (NC) for more than 3 months;
  4. 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;
  5. 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;
  6. More severe pain in the buttock and/or leg than in the lower back;
  7. Score at least 7 on Modified Roland-Morris Disability Questionnaire（RMDQ）;
  8. Central sagittal diameter stenosis of lumbar spinal canal as manifested by MRI or CT scan;
  9. Volunteer to participate the trial and provide written informed consent.

Exclusion Criteria:

  1. 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;
  2. Vascular claudication;
  3. Severe heart, pulmonary, liver and/or kidney diseases;
  4. 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;
  5. Unable to complete motorized treadmill test at the speed of 2km/h;
  6. Severe psychiatric disorder or cognitive impairment that prevent the understanding of the outcome evaluating questionnaires;
  7. A history of lumbar surgery;
  8. Have received acupuncture treatments in the previous 2 weeks;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Acupuncture
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.
Device: Acunpuncture
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 Comparator: Sham acupuncture
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.
Device: Sham acupuncture
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Weeks 6 and 18

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The proportion of participants who achieved at least 50% 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 MTT.
Weeks 6 and 18
The change 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 MTT.
Weeks 6 and 18
The change in the time to first symptoms from baseline.
Time Frame: Weeks 6 and 18
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.
Weeks 6 and 18
The change in recovery time from baseline.
Time Frame: Weeks 6 and 18
Recovery time refers to time to return to baseline pain intensity after MTT.
Weeks 6 and 18
The change in Modified Roland-Morris Disability Questionnaire (RMDQ) score from baseline.
Time Frame: Weeks 6,18 and 30
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.
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
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.
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
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.
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
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.
Weeks 6,18 and 30
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
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.
Weeks 6,18 and 30
The change in the time to first moderate pain symptom from baseline.
Time Frame: Weeks 6 and 18
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.
Weeks 6 and 18
The change in final pain intensity from baseline.
Time Frame: Weeks 6 and 18
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.
Weeks 6 and 18
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
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.
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
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.
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 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.
Weeks 6,18 and 30

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Expectance assessment
Time Frame: Baseline
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 LSS?"
Baseline
Blinding assessment
Time Frame: Within 5 minutes after the either treatment in week 6
Participants will be asked do you think you have received traditional acupuncture over the past 6 weeks.
Within 5 minutes after the either treatment in week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Zhishun Liu, PhD, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-039-KY-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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