Intelligent Moxibustion Robot in the Treatment of Low Back Pain

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

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain; Moxibustion
• Intervention / Treatment: Other: Intelligent Moxibustion Robot; Other: Artificial moxibustion

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bosong Hou, Postgraduate; Phone Number: 0086 18337320205; Email: 904225587@qq.com

Study Locations

• China
  • Shanxi
    • Datong, Shanxi, China, 034400
      • Recruiting
      • Lingqiu Hospital of Traditional Chinese Medicine
      • Contact: Wei Qiao; Phone Number: 0086 15035293780
    • Taiyuan, Shanxi, China, 030000
      • Recruiting
      • Shanxi Acupuncture and moxibustion Hospital
      • Contact: Tiansheng Zhang, doctor; Phone Number: 13466838493; Email: zts910@163.com
    • Taiyuan, Shanxi, China, 030000
      • Recruiting
      • Xinghualing Hospital of Traditional Chinese Medicine
      • Contact: Ting Xing; Phone Number: 0086 13903435942
    • Yuncheng, Shanxi, China, 044500
      • Recruiting
      • Yongji Hospital of Traditional Chinese Medicine
      • Contact: Caihong Xiang; Phone Number: 0086 13994986319

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Shanxi Acupuncture and Moxibustion Hospital
• 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
• Investigators: Study Chair: Tiansheng Zhang, doctor, Shanxi Provincial Acupuncture and Moxibustion Hospital; Principal Investigator: Bosong Hou, Postgraduate, Shanxi Provincial Acupuncture and Moxibustion Hospital; Study Director: Tiancheng Xu, doctor, Nanjing University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Anticipated): October 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 24, 2022
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Estimate): January 30, 2023

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Low Back Pain; Randomized Controlled Trial; robot; moxibustion
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: ShanxiAcupuncture

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No