TCM Conservative Treatment for the Degenerative Lumbar Spinal Stenosis
NCT05273346 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94
Last updated 2024-08-09
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.
Conditions
- Degenerative Lumbar Spinal Stenosis
Interventions
- 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.
Sponsors & Collaborators
-
Beijing University of Chinese Medicine
lead OTHER
Principal Investigators
-
Changhe Yu · Beijing University of Chinese Medicine affiliated Dongzhimen Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-01
- Primary Completion
- 2025-12-30
- Completion
- 2025-12-30
Countries
- China
Study Locations
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