NCT05704127

Brief Summary

The intelligent moxibustion robot is applied to the clinical treatment of low back pain to verify its effectiveness and safety

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

December 24, 2022

Last Update Submit

January 19, 2023

Conditions

MoxibustionLow Back Pain

Keywords

moxibustionLow Back PainrobotRandomized Controlled Trial

Outcome Measures

Primary Outcomes (22)

  • 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

Study Arms (2)

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.

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.

Other: Artificial moxibustion

Interventions

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.

Intelligent Moxibustion Robot
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.

Artificial moxibustion

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • It is consistent with the diagnostic criteria of low back pain and the syndrome differentiation criteria of cold and wet lumbar muscle strain.
  • There is no gender limitation, and the age should be between 25 and 70 years old
  • No treatment of traditional Chinese and western medicine related to lumbago was received in the past 2 weeks
  • The course of disease was controlled within 8 years
  • Informed consent, willing to cooperate with the whole treatment
  • Agree to record the scale score and volunteer to participate in this experiment
  • At least one contact information should be reserved for patients to receive follow-up visits
  • In order to reduce the rate of shedding, priority is included in hospitalized patients

You may not qualify if:

  • The patient is in the pregnancy or lactation period
  • Patients are allergic to moxibustion smoke, and it is difficult to accept moxibustion treatment
  • The patient suffers from diseases of the blood and immune system
  • Patients with cardiac, liver and renal insufficiency
  • The patient suffers from mental illness and cannot cooperate with moxibustion
  • The patient suffered from lumbar spine tuberculosis, bone cancer and other diseases, which affected the experimental results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Lingqiu Hospital of Traditional Chinese Medicine

Datong, Shanxi, 034400, China

RECRUITING

Shanxi Acupuncture and moxibustion Hospital

Taiyuan, Shanxi, 030000, China

RECRUITING

Xinghualing Hospital of Traditional Chinese Medicine

Taiyuan, Shanxi, 030000, China

RECRUITING

Yongji Hospital of Traditional Chinese Medicine

Yuncheng, Shanxi, 044500, China

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tiansheng Zhang, doctor

    Shanxi Provincial Acupuncture and Moxibustion Hospital

    STUDY CHAIR

  • Bosong Hou, Postgraduate

    Shanxi Provincial Acupuncture and Moxibustion Hospital

    PRINCIPAL INVESTIGATOR

  • Tiancheng Xu, doctor

    Affiliated Hospital of Nanjing University of Chinese Medicine

    STUDY DIRECTOR

Central Study Contacts

Bosong Hou, Postgraduate

CONTACT

0086 18337320205904225587@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2022

First Posted

January 30, 2023

Study Start

December 15, 2022

Primary Completion

October 31, 2023

Study Completion

December 31, 2023

Last Updated

January 30, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)