Clinical trial NCT05704127: Intelligent Moxibustion Robot in the Treatment of Low Back Pain
Official title: Clinical Study of Intelligent Moxibustion Robot in the Treatment of Low Back Pain: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Moxibustion
Low Back Pain
Keywords: moxibustion
Low Back Pain
robot
Randomized Controlled Trial
Lead sponsor: Shanxi Acupuncture and Moxibustion Hospital
Sponsor class: OTHER
Collaborators: name: Xinghualing Hospital of Traditional Chinese Medicine, Taiyuan City, Shanxi Province，China
name: Yongji Hospital of Traditional Chinese Medicine, Yuncheng City,Shanxi Province，China
name: Lingqiu Hospital of Traditional Chinese Medicine, Datong City,Shanxi Province，China
name: North University of China
First posted: 2023-01-30
Enrollment: 160
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Visual analogue scale(VAS score)
timeFrame: Before enrollment
measure: Visual analogue scale(VAS score)
timeFrame: After 5 treatments, an average of 1 week
measure: Visual analogue scale(VAS score)
timeFrame: Through all treatments -- after 10 treatments, an average of 2 week
measure: Visual analogue scale(VAS score)
timeFrame: 2 weeks after treatment
measure: Japanese Orthopaedic Association Score--Low Back Pain(JOA Low Back Pain Score)
timeFrame: Before enrollment
measure: Japanese Orthopaedic Association Score--Low Back Pain(JOA Low Back Pain Score)
timeFrame: After 5 treatments, an average of 1 week
measure: Japanese Orthopaedic Association Score--Low Back Pain(JOA Low Back Pain Score)
timeFrame: Through all treatments -- after 10 treatments, an average of 2 week
measure: Japanese Orthopaedic Association Score--Low Back Pain(JOA Low Back Pain Score)
timeFrame: 2 weeks after treatment
measure: 36-items short form health survey(SF-36)
timeFrame: Before enrollment
measure: 36-items short form health survey(SF-36)
timeFrame: After 5 treatments, an average of 1 week
measure: 36-items short form health survey(SF-36)
timeFrame: Through all treatments -- after 10 treatments, an average of 2 week
measure: 36-items short form health survey(SF-36)
timeFrame: 2 weeks after treatment
measure: Roland Morris Disability Questionnaire(RMDQ)
timeFrame: Before enrollment
measure: Roland Morris Disability Questionnaire(RMDQ)
timeFrame: After 5 treatments, an average of 1 week
measure: Roland Morris Disability Questionnaire(RMDQ)
timeFrame: Through all treatments -- after 10 treatments, an average of 2 week
measure: Roland Morris Disability Questionnaire(RMDQ)
timeFrame: 2 weeks after treatment
measure: Lumbar joint range of motion
timeFrame: Before enrollment
measure: Lumbar joint range of motion
timeFrame: Through all treatments -- after 10 treatments, an average of 2 week
measure: Schober test
timeFrame: Before enrollment
measure: Schober test
timeFrame: Through all treatments -- after 10 treatments, an average of 2 week
measure: Serum inflammatory response factor
timeFrame: Before enrollment
measure: Serum inflammatory response factor
timeFrame: Through all treatments -- after 10 treatments, an average of 2 week
Secondary outcomes:
Other outcomes:
Locations:
city: Datong
country: China
facility: Lingqiu Hospital of Traditional Chinese Medicine
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Acupuncture and moxibustion Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Xinghualing Hospital of Traditional Chinese Medicine
state: Shanxi
city: Yuncheng
country: China
facility: Yongji Hospital of Traditional Chinese Medicine
state: Shanxi
Study officials:
affiliation: Shanxi Provincial Acupuncture and Moxibustion Hospital
name: Tiansheng Zhang, doctor
role: STUDY_CHAIR
affiliation: Shanxi Provincial Acupuncture and Moxibustion Hospital
name: Bosong Hou, Postgraduate
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Nanjing University of Chinese Medicine
name: Tiancheng Xu, doctor
role: STUDY_DIRECTOR
References: