NCT05273346

TCM Conservative Treatment for the Degenerative Lumbar Spinal Stenosis

Traditional Chinese Medical Comprehensive Conservative Treatment for the Degenerative Lumbar Spinal Stenosis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Beijing University of Chinese Medicine · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Degenerative Lumbar Spinal Stenosis

Interventions

Type	Name	Description
BEHAVIORAL	Traditional Chinese medicinal ointment	The Group1 will be treated using the Comprehensive Conservative TCM Treatment Group protocol.The special TCM ointment will be applied to the waist, and then Tuina, in order to play the comprehensive therapeutic role of Tuina and medicine, promoting blood circulation and removing stasis, warming and dispersing cold, strengthening tendons and strengthening bones, regulating qi and blood. The method of ointment is generally used with rubbing method, rubbing method, flat pushing method and kneading method. Treatment time: 7 minutes.
BEHAVIORAL	Acupotomy	It is in the special acupoints or Ashixue for cutting, stripping and other different stimulation, in order to reduce the tension of soft tissue outside the spinal canal, reduce the trend of dynamic and static spinal canal stenosis, to achieve the purpose of relieving pain and removing disease, opening points and collaterals. Acupotomy can separate the adhesive tissue, which can improve the blood circulation of the local tissue and promote the absorption of inflammation. Most acupotomy points are tenderness points or induration points, such as yaojiaji and Shenshu. Treatment time: 3 minutes.
BEHAVIORAL	Cupping therapy with bamboo cup	Put the bamboo cup with the thickness of the thumb into the cup and boil it, then find the meridian and select the acupoint, Pierce the skin with a needle at the appropriate acupoint, and remove the heated bamboo cup from the cup while it is hot. When the temperature of the steam in the bamboo cup is reduced, steam will condense into water quickly, which produces strong negative pressure. Through the medicinal force, heat and the suction of the bamboo cup, the blood stasis in the affected area is smoothly discharged, so that qi and blood can be unblocked and pain can be eliminated. Treatment time: 20 minutes.
OTHER	Oral Chinese medicine granules	Oral Chinese medicine granules use to nourish liver and kidney, improve qi and blood. Patients voluntarily take it when they think it is necessary.
BEHAVIORAL	Epidural Steroid Injections (ESIs)	The Group2 will be treated using the Modern Medicine Conservative Treatment Program Group protocol.All Epidural Steroid Injections(ESIs) will be performed by a physician in an outpatient surgical setting(a sterile operating room),the patient will be in prone position,while monitored the vital signs. After aseptic treatment, 1mg non-granular betamethasone plus 5mL 0.9% sodium chloride solution will be injected. Patients will repeat ESIs up to four times within three months after randomization, depending on the response to the previous ESIs, when the degree of pain increases or the degree of relief is less than 50%.
BEHAVIORAL	Interferential current therapy	The 30-50cm padded electrode will be properly fixed on the left and right sides of the lumbar spinal stenosis, and the two groups of current will be crossed at the lesion. Constant frequency output 90Hz, frequency conversion output 90-100Hz, the current intensity is generally suitable for patient tolerance, each treatment for 10min, a total of 20 minutes. Twice a week for 3 months.
BEHAVIORAL	Thermal therapy	After the interferential current therapy, the patient will receive Bohm light for 5 minutes at the site of lumbar spinal stenosis and massage for 5 minutes at low back. Twice a week for 3 months.
OTHER	Oral painkillers	NSAID drugs, if necessary.

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2022-03-10
• Last updated: 2024-08-09

Locations

1 site across 1 country: China