Efficacy of Acupuncture for Lumbar Spinal Stenosis

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Unknown

Conditions: Lumbar Spinal Stenosis; Intermittent Claudication

Treatments: Other: Sham acupuncture; Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03784729

2018-161-KY

Details and patient eligibility

About

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.

Enrollment: 196 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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196 participants in 2 patient groups

Acupuncture

Experimental group

Description:

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

Treatment:

Other: Acupuncture

Sham acupuncture

Sham Comparator group

Description:

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

Treatment:

Other: Sham acupuncture