The Efficacy and Safety of Acupuncture in Relieving Neurogenic Claudication Among Patients With Lumbar Spinal Stenosis: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Zhishun Liu, PhD
zhishunjournal@163.com
86-010-88002331
Backup
Hao Yao, PhD
1242447006@qq.com
86-18801383762
Time Frame
Start Date: 2023-11-14
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 420
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

This content was sourced from clinicaltrials.gov

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