NCT06102798

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

November 14, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

January 11, 2024

Status Verified

October 1, 2023

Enrollment Period

1.9 years

First QC Date

October 22, 2023

Last Update Submit

January 9, 2024

Conditions

Lumbar Spinal Stenosis

Keywords

AcupunctureNeurogenic ClaudicationRandomized controlled trialLumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

  • 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).

    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).

    Weeks 6,18 and 30

  • The proportion of participants who achieved at least 50% improvement in total walking distance from baseline.

    Weeks 6 and 18

  • The change in total walking distance from baseline.

    Weeks 6 and 18

  • The change in the time to first symptoms from baseline.

    Weeks 6 and 18

  • The change in the time to first moderate pain symptom from baseline.

    Weeks 6 and 18

  • +9 more secondary outcomes

Other Outcomes (2)

  • Expectance assessment

    Baseline

  • Blinding assessment

    Within 5 minutes after the either treatment in week 6

Study Arms (2)

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.

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.

Device: Sham acupuncture

Interventions

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.

Acupuncture
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.

Sham acupuncture

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Zhishun Liu, PhD

    Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    STUDY CHAIR

Central Study Contacts

Zhishun Liu, PhD

CONTACT

86-010-88002331zhishunjournal@163.com

Hao Yao, PhD

CONTACT

86-188013837621242447006@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 22, 2023

First Posted

October 26, 2023

Study Start

November 14, 2023

Primary Completion

September 30, 2025

Study Completion

December 30, 2025

Last Updated

January 11, 2024

Record last verified: 2023-10

Locations

CN(1)