Acupuncture for Lumbar Spinal Stenosis

NCT ID: NCT06102798

Last Updated: 2024-01-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-14
• Study Completion Date: 2025-12-30

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).

Conditions

Lumbar Spinal Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Acunpuncture

Intervention Type: DEVICE

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 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.

Group Type: SHAM_COMPARATOR

Sham acupuncture

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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;

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Liu Zhishun

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhishun Liu, PhD

Role: STUDY_CHAIR

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Locations

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhishun Liu, PhD

Role: CONTACT

zhishunjournal@163.com

86-010-88002331

Hao Yao, PhD

Role: CONTACT

1242447006@qq.com

86-18801383762

Facility Contacts

Zhishun Liu

Role: primary

zhishunjournal@163.com

+861088002331

Other Identifiers

2023-039-KY-01

Identifier Type: -

Identifier Source: org_study_id