Clinical Study of Intelligent Moxibustion Robot in the Treatment of Low Back Pain: a Randomized Controlled Clinical Trial
Phase: NA
Conditions: Moxibustion, Low Back Pain
Sponsor: Shanxi Acupuncture and Moxibustion Hospital

Study
Protocol
the Official Title of the study：
Clinical Study of Intelligent
MoxibustionRobot in the Treatment of Low
Back Pain: a Randomized Controlled
Clinical Trial
date of the document：2022.12.15

Title: Clinical study of intelligent moxibustion robot for low back pain: a randomized clinical controlled
experiment
Background / Introduction: Moxibustion treatment has a clear effect on low back pain, but the degree of
standardization of moxibustion operation is low and almost completely depends on manual labor, and the degree
of standardization of treatment needs to be improved
Expected sample size: 80 people / group, and 160 people in 2 groups
(According to the pass software, 62 people per group, and 80 people per group are estimated receivable,
according to the shedding rate of 20%)
(To reduce shedding, priority outpatients / telephone follow-up)
(Sample size estimation method, at the end of this article)
Ranking standard:
1. Diagnosis criteria for low back pain
Diagnosis standard of traditional Chinese medicine
With reference to the published in 2018 by yu Xiaoping, fang zhu yuan editor of traditional Chinese
medicine
class
"much
starker
choices-and
graver
consequences-in
planning
textbooks"
traditional
Chinese
medicine " (the 3rd edition) in the description of cold wet type lumbar muscle strain, clinical performance
see the waist area cold pain, rainy days, hot is slow (main), or see the waist turn adverse, cold form, body
heavy (time), to see the moss white greasy tongue, pulse see heavy and slow. The patients whose syndrome type
meets the above cold and wet syndrome performance should meet the judgment criteria of TCM syndrome.
Diagnostic criteria for western medicine
According to the diagnostic criteria in document 1-2 of the Guidelines for the Treatment of Low Back Pain
formulated by the European Union:
(1) Symptoms: localized lumbar and back pain and ipsilateral muscle tension or spasm (the pain does not
radiate to the distal end of the knee joint), limited functional activity, and recurrent symptoms;
(2) Signs: physical examination, erector spinal muscles have obvious tenderness, sometimes can touch the
abnormal muscle pain points or cord muscle spasm, nervous system examination without abnormal, no obvious
muscle strength loss, sensory disorders, nerve root pull test (-), morning, bending activity, sedentary or
long standing after pain aggravation;
(3) Imaging examination: routine examination of X-ray, CT plain scan without lumbar spine and intraspinal
tumors;
(4) No history of lumbar back surgery.
References involved:
[1] 0 Airaksinen, J I Brox,C Cedraschi,et al.on behalf of the COST B13 Working Group on Guidelines for Chronic
Low
Back
Pain.European
guidelines
for
the
management
of
chronic
no
nspecificlow
back
pain[J].Eur
Spine
J,2006,15(Suppl.2):S192-S300.
[2] TROYER M R.Differential Diagnosis of Endometriosis in a Young Adult Woman With Nonspe cific Low Back
Pain[J].Phys Ther,2007,87(6):801-810.
2. Inclusion criteria:
①Compliance with the diagnostic criteria for low back pain and the syndrome differentiation criteria

for cold and wet lumbar muscle strain
②Sex is not limited, and the age is controlled between 25 years and 70 years old
③Not nearly 2 weeks ago
④
The disease course was controlled within 8 years
⑤
Informed consent and willing to cooperate with the whole treatment
⑥
They agreed to record the scale score and volunteered to participate in this trial
⑦Patients reserve at least one contact information for easy follow-up
⑧To reduce the shedding rate, the inpatients should be preferentially included
⑨Patients with lumbar disc herniation, lumbar disc bulging, sacral canal cyst, nerve root compression,
and lumbar bone hyperplasia were included
Those who meet the above 9 items can only be included in this study.
Exclusion criteria:
①Patients did not meet the inclusion criteria
Patients who did not meet the inclusion criteria for the
diagnosis of this topic
②
The patient is in pregnancy or lactation
③
Patients are allergic to moxibustion smoke, and it is difficult to accept moxibustion treatment
④
The patient had diseases of the blood and immune system
⑤
The patient had cardiac, hepatic, and renal insufficiency
⑥
The patient suffered from mental illness and failed to cooperate with moxibustion
⑦
Low back pain caused by lumbar spine and spinal canal tumors, lumbar scoliosis, bladder diseases, and
gynecological diseases
⑧Patients with a previous history of lumbar spine surgery
blind method:
RCT randomization (difficult to implement blind method, intuitive difference between robot moxibustion and
artificial moxibustion)
(Because of this experiment, total blindness cannot be achieved. Unlike drugs that can mask it,
In this experiment, the patients and the doctors saw the real "robot" or "artificial", which could not be
done too much blind method.
Therefore, to maximize blinding, staff are advised to communicate with the patient in the following manner:
1.
Multicenter trials, human and robot groups respectively in independent experimental centers
2.
Ensure that the "artificial group" does not know the existence of moxibustion robot, so as not to
ask patients to use the robot or artificial moxibustion psychological bias and other situations, affect the
treatment effect.
3.
In terms of "robot group", patients can know that moxibustion can be operated by hand with common
sense, and the robot is a new scientific research product. In order to ensure that the patient has no bias
against the robot, so as to avoid psychological factors affecting the effect.
So to inform the patient that the ingredients in the robot is the same, but the robot has a little
advantage in tobacco control and temperature control.）
Group method: random number table method
160 patients were numbered in the order of enrollment (come, come),
Using random numbers tables, 160 patients were randomly and equally divided into two groups (chart below)

Intervention mode:
Artificial moxibustion group vs. intelligent thunder-fire moxibustion group
1. Selection of points:
Taking taking: referring to the planning textbook "Treatment of Acupuncture and Moxibustion" of national
Universities
of
Traditional
Chinese
Medicine
edited
by
Gao
Shutong,
taking
nephroshu,
large
intestine,
YaoYangguan and a point.
Positioning: Select according to relevant provisions of National Standard for Positioning of Acupuncture
and Acupuncture (formulated by national GB1234-90 standard).
Kidney
yu:
in
the
waist,
when
the
second
lumbar
spinous
process,
the
side
open
1.5
inches.
Two
bilateral holes were selected each time.
Large intestine yu: in the waist, when the fourth lumbar spinous process, the side open 1.5 inches. Two
bilateral holes were selected each time.
Waist Yang: in the waist, when the posterior midline, the fourth lumbar spinprocess in the depression.
2. Course of treatment:
10 treatments for 40min.
(Each patient does it 5 times a week, and patients are usually treated for 2-3 weeks)
3. The operation mode of the moxibustion robot
(Artificial moxibustion, acupoints, technique, duration, all the same)
Enter the setting page of intelligent thunder and fire moxibustion "free moxibustion", and use the rocker to
control the six degrees of freedom robotic arm in the lumbar back of patients —— kidney yu, large intestine
yu, waist yangguan, a right point.
After
positioning,
ignite
and
install
the
lightning
fire
moxibustion
moxa
strip,
and
set
the
moxibustion operation —— on the operation page

Kidney Yu BL23, left and right 2 points, linear reciprocating moxibustion (10min)
intestinal BL25, left and right 2 points, linear reciprocating moxibustion (10min)
DU3, single point, rotary moxibustion (10min)
A is point Pain point, if unilateral pain, sparrow peck moxibustion (10min), if bilateral pain, reciprocating
moxibustion (10min)
A total of 40min was used
The
operation
method
of
reciprocating
moxibustion
is:
plane
straight
reciprocating
moxibustion,
the
mechanical arm holds the ignited thunder fire moxibustion line above the above two acupoints;
The operation method of rotary moxibustion is as follows: plane rotary moxibustion, the mechanical arm
holds the ignited lightning fire moxibustion bar for parallel reciprocrotary moxibustion above the above
acupoints, with a rotary radius of 4cm;
The operation method of sparrow pecking moxibustion is: the mechanical arm holds the selected point, and
uses the moxibustion, and the lifting range is 5cm, giving strong warm stimulation; the moxibustion distance
is manually adjusted according to the tolerance temperature of the patient.
Note: Visit the ward at any time, observe the skin condition and the heat resistance of the patient, and take
the patient comfort.
If there is discomfort, immediately stop the treatment, symptomatic treatment
4. Follow-up:
Each patient is registered with their mobile phone number,
VAS score, JOA score, RMDQ score, and SF-36 score were observed and recorded before, after 5 times, after 10
times of treatment and 2 weeks after completion of treatment (follow-up).
The values of lumbar joint motion, Schober test and serum inflammatory response factors were observed and
recorded before and after 10 treatments.
Outcome indicators:
name of index
Judgment
factors
operating steps
The
date
of
measurement
Visual analogue
scale
（VAS score）
subjectivity
Before enrollment.
After 5 treatments, an
average of 1 week.
Through all treatments
--
after
10
treatments, an average
of 2 week.
2
weeks
after
treatment.
Japanese
Orthopaedic
Association
Score--Low Back
Pain
（JOA Low Back
Pain Score）
subjectivity
Before enrollment.
After 5 treatments, an
average of 1 week.
Through all treatments
--
after
10
treatments, an average
of 2 week.
2
weeks
after
treatment.

36-items short
form health
survey
(SF-36)
subjectivity
Before enrollment.
After 5 treatments, an
average of 1 week.
Through all treatments
--
after
10
treatments, an average
of 2 week.
2
weeks
after
treatment.
Roland Morris
Disability
Questionnaire
(RMDQ)
subjectivity
Before enrollment.
After 5 treatments, an
average of 1 week.
Through all treatments
--
after
10
treatments, an average
of 2 week.
2
weeks
after
treatment.
Range of motion
of the waist
joint
objective
A professional protractor was used to measure the waist,
and the mobility of the upright forward flexion, posterior
extension, left and right lateral flexion, left and right
rotation, and the movement degree of motion was recorded.
ROM
|
lumbar
scoliosis:
_
activity
https:
/
/
www.sohu.com/a/405887556_120052195
Before enrollment.
Through all treatments
--
after
10
treatments, an average
of 2 week.
Schober Test
objective
The subject was upright and marked at 5cm below and
10cm below the lumbosacral junction. Subjects were required
to bend forward as far as possible to measure the distance
(cm)
between
the
lumbosacral
junction
and
the
marker.
Lumbar mobility was indicated using the increased distance.
https://www.bilibili.com/video/av245564019/?vd_source=20b95
3596f4eec1878458ceea7334faf
Determine whether the lumbar spine is limited
Before enrollment.
Through all treatments
--
after
10
treatments, an average
of 2 week.

Serum
inflammatory
response
factor:
Venvenous blood
4 mL, isolated
serum,
Detection by
the ELISA
method
1. Serum tumor
necrosis factor
(TNF-α),
2. Interleukin
IL 1 β,
respectively
3, the
interleukin IL
6, and the
4. Serum
thromboxane B2
(TXB 2) level.
Material
content
1. Collect
Serum separation tubes (hospital-provided),
4 mL of venous blood,
Before and after treatment, 2 times in total
2. Place
Whole blood specimens collected in serum separation tubes
were
left
at
room
temperature
for
2
hours
or
4
oC
overnight,
3. Centrization
Then centrifuged at 1,000 g for 20 min and the supernatant
was removed,
4. Freeze
Place the supernatant in the frozen storage tube (the
last
received
test
tube),
which
can
be
inserted
in
the
plastic box hole for easy storage.
Refrigerator
preservation.-20 ℃
(save
for one
month)
or-80℃to avoid repeated freezing and thawing.
5. Post inspection
After the collection, it will be packaged and mailed to
the testing center for testing
Foam case shell, with dry ice inside,
Before enrollment.
Through all treatments
--
after
10
treatments, an average
of 2 week.
Number of tasks per hospital:
1. 80 people in Shanxi Acupuncture and Moxibustion Hospital
Zhang Tiansheng, No.2, Beiyuan Street, Pingyang Road, Taiyuan city, Shanxi Province, 13466838493
2. 30 people from Xinghualing District Hospital of Traditional Chinese Medicine
The Hospital
of Traditional Chinese
Medicine,
Xinghualing District,
Taiyuan City,
Shanxi Province
(No.5,

Datong Road), Xingting, 13903435942
3. 30 people from Yongji City Hospital of Traditional Chinese Medicine
Yongji City Hospital of Traditional Chinese Medicine, No.38, South of Hedong Avenue, Yongji City, Yuncheng
City, Shanxi Province, 13994986319
4. Lingqiu County Hospital of Traditional Chinese Medicine, 20 people
Qiao Wei, Xinjian Road Hospital of Traditional Chinese Medicine, Lingqiu County, Datong City, Shanxi Province
15035293780
Hospitals should recruit as soon as possible, such as the recruitment of patients due to the epidemic and
other factors, timely communication and overall arrangements.
Attached: Sample size calculation
1.
According to the review paper, the effective rate of artificial moxibustion is about 76.19%
(Ref.: Effect of thunder-fire moxibustion combined with oblique round blade on electromyography and serum MMP
13 and PGE 2 levels in patients with lumbar intervertebral disc herniation)
Since the robot is a new product with unknown efficiency, it is assumed that it is equivalent to
artificial efficiency
2. Statistically speaking, the response efficiency difference between the two groups is 10~15%, and the two
groups are considered equivalent
3. Use the pass2011 software
Test type: Equivalent test
Calculation method: rate difference method
Efficiency difference value △: 15%,
Calculation result: 62 persons / group
The specific steps are described as follows:
Set, efficiency difference 15%. To 62 people / group, (the larger the value, the smaller the sample size)