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| Name | Class |
|---|---|
| Xinghualing Hospital of Traditional Chinese Medicine, Taiyuan City, Shanxi Province，China | UNKNOWN |
| Yongji Hospital of Traditional Chinese Medicine, Yuncheng City,Shanxi Province，China | UNKNOWN |
| Lingqiu Hospital of Traditional Chinese Medicine, Datong City,Shanxi Province，China |
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The intelligent moxibustion robot is applied to the clinical treatment of low back pain to verify its effectiveness and safety
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intelligent Moxibustion Robot | Experimental | 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. |
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| Artificial moxibustion | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intelligent Moxibustion Robot | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scale(VAS score) | 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) | Before enrollment |
| Visual analogue scale(VAS score) | 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) | After 5 treatments, an average of 1 week |
| Visual analogue scale(VAS score) | 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) | Through all treatments -- after 10 treatments, an average of 2 week |
| Visual analogue scale(VAS score) | 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) | 2 weeks after treatment |
| Japanese Orthopaedic Association Score--Low Back Pain(JOA Low Back Pain Score) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bosong Hou, Postgraduate | Contact | 0086 18337320205 | 904225587@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Tiansheng Zhang, doctor | Shanxi Provincial Acupuncture and Moxibustion Hospital | Study Chair |
| Bosong Hou, Postgraduate | Shanxi Provincial Acupuncture and Moxibustion Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lingqiu Hospital of Traditional Chinese Medicine | Recruiting | Datong | Shanxi | 034400 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 15, 2022 | Jan 19, 2023 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 15, 2022 | Jan 19, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| UNKNOWN |
| North University of China | UNKNOWN |
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| Artificial moxibustion | Other | 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. |
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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） |
| Before enrollment |
| Japanese Orthopaedic Association Score--Low Back Pain(JOA Low Back Pain Score) | 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） | After 5 treatments, an average of 1 week |
| Japanese Orthopaedic Association Score--Low Back Pain(JOA Low Back Pain Score) | 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） | Through all treatments -- after 10 treatments, an average of 2 week |
| Japanese Orthopaedic Association Score--Low Back Pain(JOA Low Back Pain Score) | 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） | 2 weeks after treatment |
| 36-items short form health survey(SF-36) | 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) | Before enrollment |
| 36-items short form health survey(SF-36) | 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) | After 5 treatments, an average of 1 week |
| 36-items short form health survey(SF-36) | 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) | Through all treatments -- after 10 treatments, an average of 2 week |
| 36-items short form health survey(SF-36) | 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) | 2 weeks after treatment |
| Roland Morris Disability Questionnaire(RMDQ) | 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) | Before enrollment |
| Roland Morris Disability Questionnaire(RMDQ) | 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) | After 5 treatments, an average of 1 week |
| Roland Morris Disability Questionnaire(RMDQ) | 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) | Through all treatments -- after 10 treatments, an average of 2 week |
| Roland Morris Disability Questionnaire(RMDQ) | 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) | 2 weeks after treatment |
| Lumbar joint range of motion | 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. | Before enrollment |
| Lumbar joint range of motion | 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. | Through all treatments -- after 10 treatments, an average of 2 week |
| Schober test | 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. | Before enrollment |
| Schober test | 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. | Through all treatments -- after 10 treatments, an average of 2 week |
| Serum inflammatory response factor | 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. | Before enrollment |
| Serum inflammatory response factor | 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. | Through all treatments -- after 10 treatments, an average of 2 week |
| Tiancheng Xu, doctor | Affiliated Hospital of Nanjing University of Chinese Medicine | Study Director |
| Shanxi Acupuncture and moxibustion Hospital | Recruiting | Taiyuan | Shanxi | 030000 | China |
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| Xinghualing Hospital of Traditional Chinese Medicine | Recruiting | Taiyuan | Shanxi | 030000 | China |
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| Yongji Hospital of Traditional Chinese Medicine | Recruiting | Yuncheng | Shanxi | 044500 | China |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |