Clinical Study of Intelligent Moxibustion Robot in the Treatment of Low Back Pain: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Japanese Orthopaedic Association Score--Low Back Pain(JOA Low Back Pain Score)
研究概览
简要总结
The intelligent moxibustion robot is applied to the clinical treatment of low back pain to verify its effectiveness and safety
详细描述
Shanxi Acupuncture and Moxibustion Hospital and North University of China jointly developed an "intelligent thunder-fire moxibustion" robot with six degrees of freedom mechanical arm as the core and will be applied in clinical practice to verify its clinical efficacy. In clinical practice, patients with low back pain were recruited jointly by several hospitals and divided into two groups. Intelligent thunder-fire moxibustion robot and artificial thunder-fire moxibustion were respectively used for treatment. The clinical efficacy and safety of intelligent thunder-fire moxibustion robot were evaluated through comparative analysis of outcome indexes such as VAS pain scale and serum inflammatory factors.
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
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.It is consistent with the diagnostic criteria of low back pain and the syndrome differentiation criteria of cold and wet lumbar muscle strain.
- •2.There is no gender limitation, and the age should be between 25 and 70 years old
- •3.No treatment of traditional Chinese and western medicine related to lumbago was received in the past 2 weeks
- •4.The course of disease was controlled within 8 years
- •5.Informed consent, willing to cooperate with the whole treatment
- •6.Agree to record the scale score and volunteer to participate in this experiment
- •7.At least one contact information should be reserved for patients to receive follow-up visits
- •8.In order to reduce the rate of shedding, priority is included in hospitalized patients
排除标准
- •1.Patients do not meet the inclusion criteria Patients who do not meet the diagnostic inclusion criteria of this subject
- •2.The patient is in the pregnancy or lactation period
- •3.Patients are allergic to moxibustion smoke, and it is difficult to accept moxibustion treatment
- •4.The patient suffers from diseases of the blood and immune system
- •5.Patients with cardiac, liver and renal insufficiency
- •6.The patient suffers from mental illness and cannot cooperate with moxibustion
- •7.The patient suffered from lumbar spine tuberculosis, bone cancer and other diseases, which affected the experimental results
研究组 & 干预措施
Intelligent Moxibustion Robot
The intelligent moxibustion robot holds the thunder fire moxibustion stick and conducts suspension moxibustion treatment on the points BL23, BL25, DU3 and pain points for 10 minutes in each group, a total of 40 minutes. BL23 and BL25 have one acupuncture point on each side of the spine, and the straight line reciprocating moxibustion technique is adopted. DU3, a single point, adopts the whirling moxibustion technique. Pain points,according to the number of pain points, choose straight reciprocating moxibustion or rotary moxibustion.
干预措施: Intelligent Moxibustion Robot (Other)
Artificial moxibustion
The people hold the thunder fire moxibustion stick and conducts suspension moxibustion treatment on the points BL23, BL25, DU3 and pain points for 10 minutes in each group, a total of 40 minutes. BL23 and BL25 have one acupuncture point on each side of the spine, and the straight line reciprocating moxibustion technique is adopted. DU3, a single point, adopts the whirling moxibustion technique. Pain points,according to the number of pain points, choose straight reciprocating moxibustion or rotary moxibustion.
干预措施: Artificial moxibustion (Other)
结局指标
主要结局
Japanese Orthopaedic Association Score--Low Back Pain(JOA Low Back Pain Score)
时间窗: 2 weeks after treatment
The questionnaire was designed to understand the impact of patients' low back pain on daily activities. According to their own conditions, the patients choose a most consistent or close answer under each item, and ultimately by the sum of scores to judge the severity of low back pain.(On a scale of 0-29, the higher the score, the better the health）
36-items short form health survey(SF-36)
时间窗: 2 weeks after treatment
As a concise health questionnaire, the SF-36 comprehensively summarizes the quality of life of the respondents from eight aspects: physiological function, physiological function, physical pain, general health status, energy, social function, emotional function and mental health.(On a scale of 0-149, the higher the score, the better the health)
Lumbar joint range of motion
时间窗: Through all treatments -- after 10 treatments, an average of 2 week
A professional protractor was used to measure the range of motion in six azimuths of waist, anterior flexion, posterior extension, left and right lateral flexion and left and right rotation in the upright position, and the degree of movement was recorded.
Visual analogue scale(VAS score)
时间窗: 2 weeks after treatment
visual analogue scale (VAS) was used to assess pain. It is widely used in clinical practice in China. The basic method is to use a walking scale about 10cm long, with 10 scales on one side and "0" and "10" respectively at both ends. 0 points means no pain and 10 points means the most unbearable pain.(On a scale of 0-10, the lower the score, the better the health)
Serum inflammatory response factor
时间窗: Through all treatments -- after 10 treatments, an average of 2 week
4 mL of venous blood was drawn from patients before and after treatment, and serum was separated and detected by ELISA. Serum tumor necrosis factor (TNF-α), interleukin IL-1β, interleukin IL-6, and serum thromboxane B2 (TXB2) were measured.
Roland Morris Disability Questionnaire(RMDQ)
时间窗: 2 weeks after treatment
The questionnaire was designed to understand the impact of patients' low back pain on daily activities. Patients choose the most consistent or close answer under each item, depending on their situation. The questionnaire consisted of 24 questions closely related to low back pain. The actual score ranges from 0 to 24, with higher scores indicating more serious dysfunction.(On a scale of 0-24, the lower the score, the better the health)
Schober test
时间窗: Through all treatments -- after 10 treatments, an average of 2 week
Subjects stood upright and were marked 5cm below and 10cm above the lumbosacral junction. Subjects were asked to bend forward as far as possible and the distance (cm) between the lumbosacral junction and the marker was measured. The increased distance was used to represent lumbar range of motion.
Visual analogue scale(VAS score)
时间窗: Before enrollment
visual analogue scale (VAS) was used to assess pain. It is widely used in clinical practice in China. The basic method is to use a walking scale about 10cm long, with 10 scales on one side and "0" and "10" respectively at both ends. 0 points means no pain and 10 points means the most unbearable pain.(On a scale of 0-10, the lower the score, the better the health)
Visual analogue scale(VAS score)
时间窗: After 5 treatments, an average of 1 week
visual analogue scale (VAS) was used to assess pain. It is widely used in clinical practice in China. The basic method is to use a walking scale about 10cm long, with 10 scales on one side and "0" and "10" respectively at both ends. 0 points means no pain and 10 points means the most unbearable pain.(On a scale of 0-10, the lower the score, the better the health)
Visual analogue scale(VAS score)
时间窗: Through all treatments -- after 10 treatments, an average of 2 week
visual analogue scale (VAS) was used to assess pain. It is widely used in clinical practice in China. The basic method is to use a walking scale about 10cm long, with 10 scales on one side and "0" and "10" respectively at both ends. 0 points means no pain and 10 points means the most unbearable pain.(On a scale of 0-10, the lower the score, the better the health)
Japanese Orthopaedic Association Score--Low Back Pain(JOA Low Back Pain Score)
时间窗: Before enrollment
The questionnaire was designed to understand the impact of patients' low back pain on daily activities. According to their own conditions, the patients choose a most consistent or close answer under each item, and ultimately by the sum of scores to judge the severity of low back pain.(On a scale of 0-29, the higher the score, the better the health）
Japanese Orthopaedic Association Score--Low Back Pain(JOA Low Back Pain Score)
时间窗: After 5 treatments, an average of 1 week
The questionnaire was designed to understand the impact of patients' low back pain on daily activities. According to their own conditions, the patients choose a most consistent or close answer under each item, and ultimately by the sum of scores to judge the severity of low back pain.(On a scale of 0-29, the higher the score, the better the health）
Japanese Orthopaedic Association Score--Low Back Pain(JOA Low Back Pain Score)
时间窗: Through all treatments -- after 10 treatments, an average of 2 week
The questionnaire was designed to understand the impact of patients' low back pain on daily activities. According to their own conditions, the patients choose a most consistent or close answer under each item, and ultimately by the sum of scores to judge the severity of low back pain.(On a scale of 0-29, the higher the score, the better the health）
36-items short form health survey(SF-36)
时间窗: Before enrollment
As a concise health questionnaire, the SF-36 comprehensively summarizes the quality of life of the respondents from eight aspects: physiological function, physiological function, physical pain, general health status, energy, social function, emotional function and mental health.(On a scale of 0-149, the higher the score, the better the health)
36-items short form health survey(SF-36)
时间窗: After 5 treatments, an average of 1 week
As a concise health questionnaire, the SF-36 comprehensively summarizes the quality of life of the respondents from eight aspects: physiological function, physiological function, physical pain, general health status, energy, social function, emotional function and mental health.(On a scale of 0-149, the higher the score, the better the health)
36-items short form health survey(SF-36)
时间窗: Through all treatments -- after 10 treatments, an average of 2 week
As a concise health questionnaire, the SF-36 comprehensively summarizes the quality of life of the respondents from eight aspects: physiological function, physiological function, physical pain, general health status, energy, social function, emotional function and mental health.(On a scale of 0-149, the higher the score, the better the health)
Roland Morris Disability Questionnaire(RMDQ)
时间窗: Before enrollment
The questionnaire was designed to understand the impact of patients' low back pain on daily activities. Patients choose the most consistent or close answer under each item, depending on their situation. The questionnaire consisted of 24 questions closely related to low back pain. The actual score ranges from 0 to 24, with higher scores indicating more serious dysfunction.(On a scale of 0-24, the lower the score, the better the health)
Roland Morris Disability Questionnaire(RMDQ)
时间窗: After 5 treatments, an average of 1 week
The questionnaire was designed to understand the impact of patients' low back pain on daily activities. Patients choose the most consistent or close answer under each item, depending on their situation. The questionnaire consisted of 24 questions closely related to low back pain. The actual score ranges from 0 to 24, with higher scores indicating more serious dysfunction.(On a scale of 0-24, the lower the score, the better the health)
Roland Morris Disability Questionnaire(RMDQ)
时间窗: Through all treatments -- after 10 treatments, an average of 2 week
The questionnaire was designed to understand the impact of patients' low back pain on daily activities. Patients choose the most consistent or close answer under each item, depending on their situation. The questionnaire consisted of 24 questions closely related to low back pain. The actual score ranges from 0 to 24, with higher scores indicating more serious dysfunction.(On a scale of 0-24, the lower the score, the better the health)
Lumbar joint range of motion
时间窗: Before enrollment
A professional protractor was used to measure the range of motion in six azimuths of waist, anterior flexion, posterior extension, left and right lateral flexion and left and right rotation in the upright position, and the degree of movement was recorded.
Schober test
时间窗: Before enrollment
Subjects stood upright and were marked 5cm below and 10cm above the lumbosacral junction. Subjects were asked to bend forward as far as possible and the distance (cm) between the lumbosacral junction and the marker was measured. The increased distance was used to represent lumbar range of motion.
Serum inflammatory response factor
时间窗: Before enrollment
4 mL of venous blood was drawn from patients before and after treatment, and serum was separated and detected by ELISA. Serum tumor necrosis factor (TNF-α), interleukin IL-1β, interleukin IL-6, and serum thromboxane B2 (TXB2) were measured.
次要结局
未报告次要终点