NCT03784729

Efficacy of Acupuncture for Lumbar Spinal Stenosis

Efficacy of Acupuncture for Intermittent Claudication of Patients With Lumbar Spinal Stenosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Acupuncture	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.
OTHER	Sham acupuncture	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.

Timeline

• Start date: 2019-03-25
• Primary completion: 2021-10-01
• Completion: 2022-03-18
• First posted: 2018-12-24
• Last updated: 2025-08-20
• Results posted: 2025-08-20

Locations

1 site across 1 country: China