Efficacy of Acupuncture for Lumbar Spinal Stenosis

Last updated: August 3, 2025
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Overall Status: Completed

Phase

N/A

Condition

Intermittent Claudication

Spondylolisthesis

Peripheral Arterial Occlusive Disease

Treatment

Acupuncture

Sham acupuncture

Clinical Study ID

NCT03784729
2018-161-KY
  • Ages 50-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meet the requirements for a clinical diagnosis of DLSS combined with a MRI- orcomputed tomography (CT)-based radiological diagnosis of central sagittal diameterstenosis 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 orwalking 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, orextending 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 lowerback;

  • Have a Roland-Morris score of at least 7;

  • Have received a MRI or CT scan within 1 year that showed the anterior posteriordiameter of the canal was ≤12 mm;

  • Are aged 50-80 years;

  • Have provided signed consent and exhibit willingness to participate in the trial.

Exclusion

Exclusion Criteria:

  • Congenital stenosis of the vertebral canal, indications of surgery for DLSS (e.g.,segmental muscular atrophy, bowel and bladder disturbances), spinal instabilityrequiring surgery, lumbar tuberculosis, lumbar metastatic carcinoma, or vertebralbody/vertebral stenosis segment compression fracture;

  • Severe vascular, pulmonary, or coronary artery disease with limited lowerextremities motility;

  • Clinical comorbidities that could interfere with the collection of data related topain 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 theassessment 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 lowerextremities instead of pain.

Study Design

Total Participants: 196
Treatment Group(s): 2
Primary Treatment: Acupuncture
Phase:
Study Start date:
March 25, 2019
Estimated Completion Date:
March 18, 2022

Connect with a study center

  • Guang An Men Hospital

    Beijing, 100053
    China

    Site Not Available

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