TCM Conservative Treatment for the Degenerative Lumbar Spinal Stenosis
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Interventions
- Behavioral: Traditional Chinese medicinal ointmentBehavioral: Epidural Steroid Injections (ESIs)Behavioral: Interferential current therapyBehavioral: AcupotomyBehavioral: Thermal therapyBehavioral: Cupping therapy with bamboo cupOther: Oral painkillersOther: Oral Chinese medicine granules
- Registration Number
- NCT05273346
- Lead Sponsor
- Beijing University of Chinese Medicine
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 94
- Diagnostic of Degenerative Lumbar Spinal Stenosis.
- Males and females aged between 40 and 85.
- Low back pain and leg pain accompanied by typical neurogenic intermittent claudication symptoms, lasting ≧3 months.
- The effect of 3 months conservative treatment(Oral painkillers + any 1 physical therapy) was not ideal(Less than 50% relief from pain or functional limitations).
- Having any of the following surgical indications: 1.Low back and leg pain after exercise, affecting life and work (the patient felt seriously affecting life and work);2. Progressive claudication(Continuous walking distance is less than 100m),or standing time is decreasing(Standing time at a time reduced to 50% of the onset);3. Those with obvious neurological defects(Suddenly appear the paresthesia of the distribution area of spinal nerve, such as numbness, acid bilges, acupuncture feeling, limb hair cool).
- The patient refused surgical treatment.
- Willing to participate in this study, and signed the informed consent.
- Patients with vasogenic intermittent claudication.
- Patients with other bone and joint diseases, including spinal vertebra fracture, lumbar tuberculosis, spinal tumor and other lesions, or rheumatism, rheumatoid arthritis.
- Patients with hematopoietic system(anemia,aplastic anemia), cardiocerebral vascular system(History of cerebral hemorrhage, Serious cardiovascular disease), endocrine system(Poor glycemic control in diabetes, such as postprandial blood glucose over 12mmol/L) and other serious primary diseases, tumors and psychosis.
- Patients with scoliosis >15° or disc instability (rotation >10° or translation >4mm).
- Patients after minimally invasive surgery and open surgery.
- Patients who received an epidural steroid injection within 6 months.
- The patient is allergic to Traditional Chinese medicine, history of skin allergy and allergic constitution.
- The treatment site has subcutaneous unknown lump, the skin is red and swollen broken ulceration inflammation or skin lesions, etc.
- Patients with severe cauda equina syndrome.
- Women who are menstruating, pregnant or breastfeeding.
- Patients with strong preferences for treatment, disobedience to random assignment, and poor compliance.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Modern Medicine Conservative Treatment Program Group Interferential current therapy 1. Epidural Steroid Injections (ESIs); 2. Interferential current therapy; 3. Thermal therapy; 4. Oral painkillers. Modern Medicine Conservative Treatment Program Group Thermal therapy 1. Epidural Steroid Injections (ESIs); 2. Interferential current therapy; 3. Thermal therapy; 4. Oral painkillers. Modern Medicine Conservative Treatment Program Group Oral painkillers 1. Epidural Steroid Injections (ESIs); 2. Interferential current therapy; 3. Thermal therapy; 4. Oral painkillers. Comprehensive Conservative TCM Treatment Group Acupotomy 1. Traditional Chinese medicinal ointment; 2. Acupotomy; 3. Cupping therapy with bamboo cup; 4. Oral Chinese medicine granules. Comprehensive Conservative TCM Treatment Group Cupping therapy with bamboo cup 1. Traditional Chinese medicinal ointment; 2. Acupotomy; 3. Cupping therapy with bamboo cup; 4. Oral Chinese medicine granules. Comprehensive Conservative TCM Treatment Group Oral Chinese medicine granules 1. Traditional Chinese medicinal ointment; 2. Acupotomy; 3. Cupping therapy with bamboo cup; 4. Oral Chinese medicine granules. Comprehensive Conservative TCM Treatment Group Traditional Chinese medicinal ointment 1. Traditional Chinese medicinal ointment; 2. Acupotomy; 3. Cupping therapy with bamboo cup; 4. Oral Chinese medicine granules. Modern Medicine Conservative Treatment Program Group Epidural Steroid Injections (ESIs) 1. Epidural Steroid Injections (ESIs); 2. Interferential current therapy; 3. Thermal therapy; 4. Oral painkillers.
- Primary Outcome Measures
Name Time Method The long-term response rate The 15rd month Using the Zurich Claudication Questionnaire (ZCQ) as the standard for calculating response rate in this study, the decrease of symptom severity subscale and physiological function subscale score ≥0.5 points represents "success". A decrease of ≥2.5 points in the satisfaction subscale represents "success". When at least two subscales are judged to be "successful", the treatment is judged to be effective, thus the response rate is calculated.In ZCQ, the greater the difference between the two measurements before and after (the lower the score of the latter measurement), the better degree of recovery.
The short-term response rate The 3rd month The NASS guidelines recommend the use of response rate as the primary criterion for determining performance due to the variety, complexity and repeatability of DLSS performance. The Zurich Claudication Questionnaire (ZCQ) is considered by the North American Spine Association (NASS) to be the best and most specific assessment method. It is the "gold standard" to evaluate the function of patients with lumbar spinal stenosis. Therefore, as the standard for calculating effective rate in this study, the decrease of symptom severity subscale and physiological function subscale score ≥0.5 points represents "success". A decrease of ≥2.5 points in the satisfaction subscale represents "success". When at least two subscales are judged to be "successful", the treatment is judged to be effective, thus the response rate is calculated.In ZCQ, the greater the difference between the two measurements before and after (the lower the score of the latter measurement), the better degree of recovery.
- Secondary Outcome Measures
Name Time Method Changes in pain level The time points of evaluation were baseline, 3,6,9,12 and 15 months. The severity of leg pain and low back pain within 24 hours was assessed by the Digital Pain Scale (NRS).10 is the highest score, indicating unbearable pain. 0 is the lowest score, meaning no pain.The higher the NRS score, the more intense of the pain.
Changes in locomotor function The time points of evaluation were baseline, 3,6,9,12 and 15 months. The Oswestry Disability Index (ODI) consists of 10 items, including pain, individual disability and general disability. The lowest score for each item is 0, and the highest score is 5, with higher scores indicating higher levels of dysfunction. After the corresponding scores of the answers of the 10 items are accumulated, the percentage of the answers to the highest total score (50 points) is calculated, which is ODI. The higher the score is, the more serious the patient's dysfunction is.
Incidence of surgery The evaluation time point was 3,6,9,12, and 15 months. The incidence of patients attending surgical treatment was recorded at any time.
Changes in general health status The time points of evaluation were baseline, 3,6,9,12 and 15 months. Chinese version of SF12 was used to evaluate the overall health status, including total physical health score and total mental health score.After the formula score calculation, the higher the score, the better the health.
Trial Locations
- Locations (1)
Dongzhimen hospital affiliated to Bejing University of Chinese Medicine
🇨🇳Beijing, Beijing, China