Efficacy of Acupuncture for Lumbar Spinal Stenosis

NCT03784729 | Completed Results

• 1 other identifier: 2018-161-KY
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

Degenerative lumbar spinal stenosis (DLSS) is a condition which there is narrowing space of sagittal diameter of spinal canal or nerve root canal for spinal nerve or cauda equina secondary to degenerative changes. DLSS is a common cause of gluteal or lower extremity pain, women and elderly people aged 60-70 are more likely to have DLSS. The early symptoms of this disease are soreness and pain in the low back, gluteal region and posterior region of thighs which can be relieved after resting or changing posture. Being accompanied with gradually aggravated symptoms, patients with DLSS may have neurogenic claudication with hypoesthesia and numbness in lateral lower legs and feet, additionally, few patients may have bowel and bladder disturbances. In accordance of the guidelines of North American Spine Society (NASS), treatment options comprise surgical therapy, epidural steroid injections and physical therapy and transcutaneous electrical stimulation, however, the long-term efficacy of surgery is not superior to that of non-surgical therapy. Moreover, the short-term efficacy of non-surgical therapy is with insufficient evidence. According to a systematic review and recent studies, acupuncture may improve the symptoms of patients and their quality of life, however, there is a lack of placebo-controlled and large sample sized study.

Conditions

Lumbar Spinal Stenosis; Intermittent Claudication

Outcome Measures

Primary Outcomes (1)

• The Change in Modified Roland-Morris Disability Questionnaire (RMDQ) Score From Baseline

  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, and there is a phrase "caused by low back pain" after each question which could excluded other reasons for dysfunction of the back. For this scale, higher scores indicate more severe symptoms.

  week 6

Secondary Outcomes (35)

• The Change in Modified Roland-Morris Disability Questionnaire (RMDQ) Score From Baseline

  week 18

• The Change in Modified Roland-Morris Disability Questionnaire (RMDQ) Score From Baseline

  week 30

• The Percentage of Participants With at Least 30% Reduction From Baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)

  week 6

• The Percentage of Participants With at Least 30% Reduction From Baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)

  week 18

• The Percentage of Participants With at Least 30% Reduction From Baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)

  week 30

Other Outcomes (3)

• The Percentage of Patients Who Have Expectancy of Acupuncture

  Baseline

• The Percentage of Patients With Successful Blinding

  Week 6

• Number of Participants With Adverse Events

  week 1 to week 30

Study Arms (2)

Acupuncture

EXPERIMENTAL

The acupoints of Shenshu (BL23), "Dachangshu (BL25)", Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted.

Other: Acupuncture

Sham acupuncture

SHAM COMPARATOR

The acupoints of Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted into a depth of 2-3mm.

Other: Sham acupuncture

Interventions

Acupuncture OTHER

The acupoints of Shenshu (BL23), "Dachangshu (BL25)", Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted. For the bilateral" BL25", sterile disposable steel needles (Huatuo, Suzhou, China; 0.3 mm×75 mm) will be inserted to a depth of 50-70mm until 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 (Huatuo, Suzhou, China; 0.3 mm×40 mm) will be inserted to a depth of 15-25 mm, gently rotated three times and lifted to achieve de qi. It should be noted that the needle at KI3 will be inserted at an angle of 45°obliquely downward. There will be 18 treatment sessions with 3 times a week for continuous 6 weeks and a 30 min treatment per session.

Acupuncture

Sham acupuncture OTHER

The acupoints of Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted into a depth of 2-3mm .No manipulation of needles without deqi will be conducted. The treatment duration and frequency of sessions for participants in the SA group will be the same as in the acupuncture group.

Sham acupuncture

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the requirements for a clinical diagnosis of DLSS combined with a MRI- or computed tomography (CT)-based radiological diagnosis of central sagittal diameter stenosis of the lumbar spinal canal;
• Have neurogenic intermittent claudication (IC) characterized by progressive pain, numbness, weakness, and tingling of the buttocks and/or legs when standing or walking or with extension of the back, which are relieved upon sitting, lying down, or bending forward \[22\]; they must always walk in flexion or hunchback posture;
• Have pain of an intensity ≥4 in the buttocks and/or legs when walking, standing, or extending the back, as measured using the Numerical Rating Scale (NRS);
• Have pain in the buttock and/or leg that is more severe than their pain in the lower back;
• Have a Roland-Morris score of at least 7;
• Have received a MRI or CT scan within 1 year that showed the anterior posterior diameter of the canal was ≤12 mm;
• Are aged 50-80 years;
• Have provided signed consent and exhibit willingness to participate in the trial.

You may not qualify if:

• Congenital stenosis of the vertebral canal, indications of surgery for DLSS (e.g., segmental muscular atrophy, bowel and bladder disturbances), spinal instability requiring surgery, lumbar tuberculosis, lumbar metastatic carcinoma, or vertebral body/vertebral stenosis segment compression fracture;
• Severe vascular, pulmonary, or coronary artery disease with limited lower extremities motility;
• Clinical comorbidities that could interfere with the collection of data related to pain and walking function such as fibromyalgia, chronic widespread pain, amputation, stroke, Parkinson's disease, spinal cord injury, and dementia;
• Cognitive impairment, such that they are unable to understand the content of the assessment scales or provide accurate data;
• A history of lumbar surgery;
• Plans to become pregnant within 12 months or are already pregnant;
• Received acupuncture treatments for DLSS within the previous 30 days;
• Neurogenic IC mainly manifesting as numbness, weakness, or paraesthesia of the lower extremities instead of pain.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang An Men Hospital

Beijing, 100053, China

Location

Related Publications (2)

• Zhu L, Sun Y, Kang J, Liang J, Su T, Fu W, Zhang W, Dai R, Hou Y, Zhao H, Peng W, Wang W, Zhou J, Jiao R, Sun B, Yan Y, Liu Y, Liu Z. Effect of Acupuncture on Neurogenic Claudication Among Patients With Degenerative Lumbar Spinal Stenosis : A Randomized Clinical Trial. Ann Intern Med. 2024 Aug;177(8):1048-1057. doi: 10.7326/M23-2749. Epub 2024 Jul 2.

  PMID: 38950397 DERIVED

• Zhou J, Liu S, Sun Y, Wang W, Liu Z. Efficacy of acupuncture for treatment of intermittent claudication in patients with degenerative lumbar spinal stenosis: protocol for a randomized controlled trial. Trials. 2020 Jul 25;21(1):679. doi: 10.1186/s13063-020-04612-8.

  PMID: 32711555 DERIVED

MeSH Terms

Conditions

Spinal Stenosis; Intermittent Claudication

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Zhishun Liu
• Organization: Guang'anmen Hospital, China Academy Chinese Medical Sciences

liuzhishun@aliyun.com

+86 010 88002331

Study Officials

• Yan Liu, Master

  Beijing University of Chinese Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 24, 2018
• Study Start: March 25, 2019
• Primary Completion: October 1, 2021
• Study Completion: March 18, 2022
• Last Updated: August 20, 2025
• Results First Posted: August 20, 2025

Record last verified: 2025-08

Locations

CN (1)