Clinical trial NCT05273346: TCM Conservative Treatment for the Degenerative Lumbar Spinal Stenosis
Official title: Traditional Chinese Medical Comprehensive Conservative Treatment for the Degenerative Lumbar Spinal Stenosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Degenerative Lumbar Spinal Stenosis
Keywords: low back pain
leg pain
Spinal Stenosis
Lead sponsor: Beijing University of Chinese Medicine
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 94
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The short-term response rate
timeFrame: The 3rd month
measure: The long-term response rate
timeFrame: The 15rd month
Secondary outcomes:
measure: Changes in pain level
timeFrame: The time points of evaluation were baseline, 3,6,9,12 and 15 months.
measure: Changes in general health status
timeFrame: The time points of evaluation were baseline, 3,6,9,12 and 15 months.
measure: Changes in locomotor function
timeFrame: The time points of evaluation were baseline, 3,6,9,12 and 15 months.
measure: Incidence of surgery
timeFrame: The evaluation time point was 3,6,9,12, and 15 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen hospital affiliated to Bejing University of Chinese Medicine
state: Beijing
Study officials:
affiliation: Beijing University of Chinese Medicine affiliated Dongzhimen Hospital
name: Changhe Yu
role: PRINCIPAL_INVESTIGATOR
References: