Degenerative Lumbar Spinal Stenosis Clinical Trial
Official title:
Traditional Chinese Medical Comprehensive Conservative Treatment for the Degenerative Lumbar Spinal Stenosis
Lumbar degenerative disease is a common disease develops into degenerative lumbar spinal stenosis(DLSS)in the elderly and eventually. The long course of disease and other characteristics determine that conservative treatment cannot be effective in a short time, surgery is recommended to relieve symptoms quickly. However, the incidence of complications and disease recurrence rate after surgical treatment is high, and the reoperation rate is as high as 30-50%. Conservative treatment has the advantages of low price and high acceptance, so the treatment strategy first returns to conservative treatment.The complexity and repeatability of DLSS are the main reasons for the adoption of comprehensive treatment in modern medicine, but the efficacy is not significant. Traditional Chinese medicine (TCM) has its own theories and various methods to treat low back pain.
Under the guidance of TCM holistic view and syndrome differentiation views, the treatment group invented the concept of treating with tendon instead of bone and miscellaneous combination, and initially formed a four-dimensional integrated TCM comprehensive conservative diagnosis and treatment plan of moderate and severe DLSS, which is mainly composed of cupping therapy with bamboo cup, assisting with acupotomy, repairing with Traditional Chinese medicinal ointment and regulating body with Chinese herb decoction. Based on evidence-based evidence, this study optimized and verified the comprehensive plan of TCM, and finally formed the technical specification, so as to enrich and improve DLSS conservative diagnosis and treatment technology, provide clinical evidence of comprehensive plan of TCM, and improve the ability of TCM to treat difficult and serious diseases. Based on the above,the investigators will carry out a randomized controlled trial (RCT) to verify the effectiveness and safey of TCM comprehensive conservative treatment. A total of 94 patients with moderate to severe DLSS were included and randomly assigned to the experimental group and the control group according to 4:3, including 53 patients in the experimental group and 41 patients in the control group. The experimental group received the comprehensive conservative treatment for 3 months, the control group accepted the modern comprehensive medical conservative treatment, treatment for 3 months, main efficacy outcome indicators for 3 months, 15 months after random based on efficient Zurich Claudication questionnaire(ZCQ), secondary outcome indicators including pain rating scale, SF-12 questionnaire. ;
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