The Effectiveness and Safety of Traditional Korean Medicine for Symptomatic Lumbar Spinal Spondylolisthesis: a Randomized Controlled International Collaborative Multi-center Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 115
- 试验地点
- 4
- 主要终点
- 0 to 100 Visual Analogue Scale (VAS) for low back pain
研究概览
简要总结
This is a clinical trial for evaluating the safety and effectiveness of the Mokhuri intensive treatment program regarding pain and function before and after treatment between a group receiving the Mokhuri intensive treatment program (Chuna, acupuncture, and patient education) for five weeks and another group receiving non-surgical conventional standard treatment (drugs for pain relief, epidural steroid injection treatment, and physical therapy).
The trial will be conducted through international cooperation between Mayo Clinic in the United States and Mokhuri Oriental Medicine Hospital in Korea. All subjects in Korea and the US will be selected based on the same inclusion criteria and exclusion criteria. All subjects in the treatment arm will receive the same treatment in Korea and the US. In collaboration and with the support of Mayo Clinic's Department of Integrative Medicine and Health, and to ensure treatment consistency between Korea and the US, an acupuncturist from the USA will travel to Korea and train on-site for one month in Mokhuri hospital.
The trial subjects who agree to participate in the clinical trial after providing informed consent will receive the required examinations and tests according to the clinical trial plan. If they are appropriate for this clinical trial and eligible based on the Inclusion and exclusion criteria, they will be randomly assigned to the group that will undergo the focused Mokhuri intensive treatment program and to the group that will receive non-surgical conventional treatment on their second visit. All the subjects in this study will be educated regarding the study procedure and scheduled visits and will participate in the allocated treatments for five weeks. Afterwards, clinical outcomes of both groups will be evaluated after end of the treatments from between a week and five weeks (within +7 days). The clinical trial ends after the follow-up evaluations that will take place 12 weeks, 24 weeks, 48 weeks, and 96 weeks after the end of the treatment evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Independent outcome assessors who do not know allocation result will participate in the outcome assessment.
入排标准
- 年龄范围
- 19 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with all the following requirements will be included as appropriate subjects in the clinical trial:
- •Those aged from 19 to 78 years
- •Those with a diagnosis of degenerative lumbar spinal spondylolisthesis and have low back pain, lower limb radiating pain, or leg discomfort when standing or walking with severity of at least 50 in a 0 to 100 VAS for each symptom
- •Those suffering from neurologic claudication or radicular pain at least for one year
- •Those with neurogenic claudication within five minutes when walking on a treadmill at the speed of 1.5 miles per hour
- •Those not receiving epidural injection treatments within the past one month
- •Those who have not undergone lumbar surgery
- •Those who confirmed spondylolisthesis on L-spine AP, lateral & both oblique views
- •Those who weigh 250 lbs (113.398 kg) or less
- •Those who are 2.1 m (6.890 ft) in height or shorter
- •Those agreeing to participate in this clinical trial after receiving a thorough explanation of the purposes and characteristics of the trial and who have also signed the written informed consent form.
排除标准
- •Subjects will be excluded for the following conditions:
- •Those with a history of diseases in the past or in the present that cause ambulatory functional disability
- •Those with knee joint and hip joint disorders that severely limit walking (i.e. moderate or severe osteoarthritis in the knee or hip joints)
- •Those who has been diagnosed as peripheral blood vessel diseases or vascular diseases in the past, shows an ankle-brachial index (ABI) below 0.9 or is diagnosed as peripheral artery disease by Doppler ultrasonography of lower limbs, if necessary
- •Those with severe diseases (cardiac disorders or renal insufficiency) such that the ambulatory evaluation is not attainable
- •Those with other specific spinal diseases (ankylosing spondylitis, spinal osteomyelitis, metabolic diseases, severe osteoporosis, etc.)
- •Those with severe neurological defects including foot drop or cauda equina syndrome
- •Those with spinal instability confirmed by L-spine x-ray flexion and extension views. Spinal instability will be defined as observing one or more of the following: 4.5 mm sagittal plane translation, 20 degrees of sagittal plane rotation at L4-5, or 25 degrees of sagittal plane rotation at L5-S
- •Those with malignancy
- •Those with psychiatric conditions such as major depressive disorder and anxiety disorder in the past or present (e.g., panic disorder, episodes of mania, delusion, and schizophrenia)
- •Those using narcotic analgesics, including the external dosage form or patch
- •Those on medications for respiratory diseases including gastritis, stomach ulcer, and irritable bowel syndrome
- •Pregnant women, lactating women, or those planning to become pregnant
- •Those who appear likely to encounter difficulties in adhering to this protocol such as those regarding treatment, hospitalization, or preparation for the survey
- •Those subjects who the clinical investigators judge to be inappropriate
结局指标
主要结局
0 to 100 Visual Analogue Scale (VAS) for low back pain
时间窗: 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
The degree of pain recognized as backache is indicated on a 100 mm straight line. The participant is to indicate the average level of lumbar pain experienced for the past one week.
次要结局
- Zurich Claudication Questionnaire (ZCQ)(2nd, 6th, 7th, 18th, 30th, 54th and 102th weeks)
- Oswestry Disability Index(2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks)
- Roland-Morris Disability Questionnaire (RMDQ)(2nd, 6th, 7th, 18th, 30th, 54th and 102th weeks)
- Walking duration and distance free of leg pain(2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks)
- Investigation for the presence of any additional spondylolisthesis treatment and the types thereof(18th, 30th, 54th and 102th weeks)
- The ratio between the actual duration of participation and the originally scheduled duration in each group(7th week)
- Treadmill test(1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks)
- Adverse event assessments(2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks)
- 0 to 100 Visual Analogue Scale (VAS) for leg pain(1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks)
- EQ-5D(2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks)
研究者
Kim Ki Ok
President
Mokhuri Oriental Hospital