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Acupuncture for Lumbar Spinal Stenosis

G

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status

Enrolling

Conditions

Lumbar Spinal Stenosis

Treatments

Device: Acunpuncture
Device: Sham acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT06102798
2023-039-KY-01

Details and patient eligibility

About

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).

Enrollment

420 estimated patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

420 participants in 2 patient groups

Acupuncture
Experimental group
Description:
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.
Treatment:
Device: Acunpuncture
Sham acupuncture
Sham Comparator group
Description:
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.
Treatment:
Device: Sham acupuncture

Trial contacts and locations

1

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Central trial contact

Zhishun Liu, PhD; Hao Yao, PhD

Data sourced from clinicaltrials.gov

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