MoxibustionNCT05704127
Intelligent Moxibustion Robot in the Treatment of Low Back Pain
A study testing Intelligent Moxibustion Robot and Artificial moxibustion in people with Moxibustion and Low Back Pain, run by Shanxi Acupuncture and Moxibustion Hospital at 4 sites in China.
Trial summary
The intelligent moxibustion robot is applied to the clinical treatment of low back pain to verify its effectiveness and safety Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Moxibustion, Low Back Pain
- What is being tested?
- Intelligent Moxibustion Robot and Artificial moxibustion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesChina
- Study dates
- 15 Dec 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Lingqiu Hospital of Traditional Chinese Medicine
Datong, Shanxi, 034400
Wei Qiao, 0086 15035293780
- Recruiting
Shanxi Acupuncture and moxibustion Hospital
Taiyuan, Shanxi, 030000
Tiansheng Zhang, doctor, 13466838493, zts910@163.com
- Recruiting
Xinghualing Hospital of Traditional Chinese Medicine
Taiyuan, Shanxi, 030000
Ting Xing, 0086 13903435942
- Recruiting
Yongji Hospital of Traditional Chinese Medicine
Yuncheng, Shanxi, 044500
Caihong Xiang, 0086 13994986319
About this study
Official title: Clinical Study of Intelligent Moxibustion Robot in the Treatment of Low Back Pain: a Randomized Controlled Clinical Trial
The intelligent moxibustion robot is applied to the clinical treatment of low back pain to verify its effectiveness and safety
Read the detailed description
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.
- Conditions
- Moxibustion, Low Back Pain
- Being tested
- Intelligent Moxibustion Robot, Artificial moxibustion
- Keywords
- moxibustion, Low Back Pain, robot, Randomized Controlled Trial
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent Moxibustion RobotOther
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.
Artificial moxibustionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Intelligent Moxibustion Robot |
| 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. Receives: Other: Artificial moxibustion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 2 weeks after treatment
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）
Measured: 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）
Measured: 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）
Measured: 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）
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: Through all treatments -- after 10 treatments, an average of 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start15 Dec 2022
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoxibustionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Acupuncture and Moxibustion Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xinghualing Hospital of Traditional Chinese Medicine, Taiyuan City, Shanxi Province，China, Yongji Hospital of Traditional Chinese Medicine, Yuncheng City,Shanxi Province，China, Lingqiu Hospital of Traditional Chinese Medicine, Datong City,Shanxi Province，China, North University of China
- Responsible party
- Sponsor
- Investigators
- Tiansheng Zhang, doctor, Study chair, Shanxi Provincial Acupuncture and Moxibustion HospitalBosong Hou, Postgraduate, Principal investigator, Shanxi Provincial Acupuncture and Moxibustion HospitalTiancheng Xu, doctor, Study director, Affiliated Hospital of Nanjing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704127
- Sponsor's protocol ID
- ShanxiAcupuncture
- Status last verified
- Jan 2023
- First submitted
- 24 Dec 2022
- Last updated
- 30 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Intelligent Moxibustion Robot in the Treatment of Low Back Pain: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05704127
- Acronym / sponsor ID
- ShanxiAcupuncture
- Conditions
- Moxibustion, Low Back Pain
- Keywords
- moxibustion, Low Back Pain, robot, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanxi Acupuncture and Moxibustion HospitalUniversity, hospital or other
- Collaborators
- Xinghualing Hospital of Traditional Chinese Medicine, Taiyuan City, Shanxi Province，China, Yongji Hospital of Traditional Chinese Medicine, Yuncheng City,Shanxi Province，China, Lingqiu Hospital of Traditional Chinese Medicine, Datong City,Shanxi Province，China, North University of China
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The intelligent moxibustion robot is applied to the clinical treatment of low back pain to verify its effectiveness and safety
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intelligent Moxibustion Robot | Experimental | Other: Intelligent Moxibustion RobotThe 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. |
| Artificial moxibustion | Experimental | Other: Artificial moxibustionThe 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. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intelligent Moxibustion RobotThe 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. | Other | Intelligent Moxibustion Robot |
| Artificial moxibustionThe 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. | Other | Artificial moxibustion |
Primary outcome
Visual analogue scale(VAS score)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Visual analogue scale(VAS score)
Time frame: 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)
Japanese Orthopaedic Association Score--Low Back Pain(JOA Low Back Pain Score)
Time frame: 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)
Time frame: 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)
Time frame: 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）
Japanese Orthopaedic Association Score--Low Back Pain(JOA Low Back Pain Score)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
36-items short form health survey(SF-36)
Time frame: 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)
Roland Morris Disability Questionnaire(RMDQ)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Roland Morris Disability Questionnaire(RMDQ)
Time frame: 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)
Lumbar joint range of motion
Time frame: 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.
Lumbar joint range of motion
Time frame: 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.
Schober test
Time frame: 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.
Schober test
Time frame: 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.
Serum inflammatory response factor
Time frame: 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.
Serum inflammatory response factor
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiansheng Zhang, doctor study chair
Shanxi Provincial Acupuncture and Moxibustion Hospital
Bosong Hou, Postgraduate principal investigator
Shanxi Provincial Acupuncture and Moxibustion Hospital
Tiancheng Xu, doctor study director
Affiliated Hospital of Nanjing University of Chinese Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intelligent Moxibustion Robot and Artificial moxibustion in people with Moxibustion and Low Back Pain, run by Shanxi Acupuncture and Moxibustion Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bosong Hou, Postgraduate (0086 18337320205, 904225587@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale(VAS score) (time frame: Before enrollment). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.