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Verification of Therapeutic Effects and Observation of Mechanisms of Action in Non-Specific Low Back Pain Patients Using an Intelligent Massage Robot with Finite Element Analysis-Based Design

Registration number：

ITMCTR2025000531

Date of Last Refreshed on：

2025-03-14

Date of Registration：

2025-03-14

Registration Status：

Prospective registration

Public title：

Verification of Therapeutic Effects and Observation of Mechanisms of Action in Non-Specific Low Back Pain Patients Using an Intelligent Massage Robot with Finite Element Analysis-Based Design

English Acronym：

Scientific title：

Verification of Therapeutic Effects and Observation of Mechanisms of Action in Non-Specific Low Back Pain Patients Using an Intelligent Massage Robot with Finite Element Analysis-Based Design

Scientific title acronym：

Study subject ID：

2024CCRZD007

The registration number of the Partner Registry or other register：

Applicant：

Fengxi Qiu

Study leader：

Qilong Hu Fengxi Qiu

Applicant telephone：

15800582084

Study leader's telephone：

15800582084

Applicant Fax：

Study leader's fax：

Applicant E-mail：

18232576158@163.com

Study leader's E-mail：

18232576158@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 2209 Guangxing Road Songjiang District Shanghai

Study leader's address：

No. 2209 Guangxing Road Songjiang District Shanghai

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Shanghai Yangzhi Rehabilitation Center (Shanghai Sunshine Rehabilitation Center)

Approved by ethic committee：

Approved No. of ethic committee：

Ec Form 045

Approved file of Ethical Committee：

View

Name of the ethic committee：

The Medical Ethics Committee of Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)

Date of approved by ethic committee：

2024/9/18 0:00:00

Contact Name of the ethic committee：

Xiaofan Wang

Contact Address of the ethic committee：

No. 2209 Guangxing Road Songjiang District Shanghai

Contact phone of the ethic committee：

377300113060

Contact email of the ethic committee：

yzkfllwyh@163.com

Primary sponsor：

The Medical Ethics Committee of Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)

Primary sponsor's address：

No. 2209 Guangxing Road Songjiang District Shanghai

Secondary sponsor：

Country：

China

Province：

Shanghai

City：

Institution
hospital：

The Medical Ethics Committee of Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)

Address：

No. 2209 Guangxing Road Songjiang District Shanghai

Source(s) of funding：

Internal Clinical Research Program

Target disease：

Non-specific low back pain

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

This study aims to investigate the potential and value of intelligent massage robots in the clinical management of non-specific low back pain and to elucidate the biomechanical mechanisms of Tuinas efficacy using finite element analysis techniques.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Those who meet the diagnostic criteria for nonspecific low back pain as defined in the Chinese Expert Consensus on the Diagnosis and Treatment of Acute/Chronic Nonspecific Low Back Pain; (2) Aged 18-75 years regardless of gender; (3) Have not received any other NLBP-related treatments in the week prior to treatment; (4) Voluntarily participate in this clinical trial and provide signed informed consent; (5) Have a visual analogue scale (VAS) score ≥ 3 and ≤ 6; (6) All participants will undergo a lumbar spine CT scan prior to the trial.

Exclusion criteria：

(1) History of prior lumbar spine surgery; (2) Mental illness or intellectual disability; (3) Presence of severe cardiovascular or cerebrovascular disease hepatic or renal impairment other organ diseases infectious diseases or coagulation disorders; (4) Pregnant or breastfeeding women; (5) Currently participating in another clinical trial; (6) Those unable to give written informed consent.

Study execute time：

From 2024-01-01

To      2025-12-10

Recruiting time：

From 2025-04-01

To      2025-08-31

Interventions：

34

Group：

Arm massage group

Sample size：

Intervention：

Smart arm massage

Intervention code：

34

Group：

Physician massage group

Sample size：

Intervention：

Medical massage

Intervention code：

Total sample size ： 68

Countries of recruitment
and research settings：

Country：

China

Province：

Shanghai

City：

Institution/hospital：

The Medical Ethics Committee of Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)

Level of the institution：

Grade III Hospital

Outcomes：

Outcome：

lumbar range of motion (ROM)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Measurement of Pressure Pain Threshold (PPT)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Visual Analog Scale (VAS)

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Short Form-12

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

ODI

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Japanese Orthopaedic Associationscores

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Not yet recruiting

18
Min age years
75
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Random sequence obtained by quality supervisor in Excel

Blinding：

The study employs code breaking for unblinding: Treatment group information is coded and concealed until the completion of the trial. This unblinding procedure mitigates bias during the study and ensures the objectivity of the findings.

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Not public

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

(1) Project implementation quality control technical measures: the selection of research objects and research methods follow the principle of standardization; The main observation indicators should be accurate and repeatable; Make a list of items to be observed in the research to ensure that important information is not omitted; Develop a manual of instructions for conducting research projects so that all researchers are clear about their responsibilities; Specify quality control indicators. As the evaluation standard the participants were evaluated before and during the study. (2) Filling in the case report form: Filling in the CRF form requires truthful detailed and careful recording of the contents of the form to ensure that the contents of the case report form are true and reliable. The case report form shall not be altered at will if there is a clerical error you can only draw a line on the wrong items fill in the correct content and sign next to it indicating the date. (3) Accuracy of data: All observations and findings in clinical trials should be verified to ensure the authenticity and reliability of the data to ensure that all conclusions in clinical trials are derived from the original data and corresponding management measures should be taken in the clinical trial and data processing stage. (4) The database is maintained and managed by specialized personnel.

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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