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A randomized controlled study of knee care and rational knee care for out-of-hospital daily treatment of patients with knee pain

Registration number：

ITMCTR2024000482

Date of Last Refreshed on：

2024-09-25

Date of Registration：

2024-09-25

Registration Status：

Prospective registration

Public title：

A randomized controlled study of knee care and rational knee care for out-of-hospital daily treatment of patients with knee pain

English Acronym：

Scientific title：

A randomized controlled study of knee care and rational knee care for out-of-hospital daily treatment of patients with knee pain

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

YIN Jiyao

Study leader：

WANG Junwen

Applicant telephone：

+86 176 1166 9763

Study leader's telephone：

+86 136 8309 5130

Applicant Fax：

Study leader's fax：

Applicant E-mail：

yy13505219957@163.com

Study leader's E-mail：

64030398@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No.16 Dongzhimen Neinan Xiaojie, Dongcheng District, Beijing

Study leader's address：

No.16 Dongzhimen Neinan Xiaojie, Dongcheng District, Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences

Approved by ethic committee：

Approved No. of ethic committee：

2024EC-KY-023

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of the Institute of Basic Theory of Chinese Medicine China Academy of Chinese Medical Sciences

Date of approved by ethic committee：

2024/7/1 0:00:00

Contact Name of the ethic committee：

YUE Guangxin

Contact Address of the ethic committee：

Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences

Contact phone of the ethic committee：

010-64089013

Contact email of the ethic committee：

jcsec@126.com

Primary sponsor：

Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences

Primary sponsor's address：

No.16 Dongzhimen Neinan Xiaojie, Dongcheng District, Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

Beijing Hospital

Address：

No.1 Dahua Road, Dongdan, Dongcheng District, Beijing

Country：

China

Province：

Beijing

City：

Institution
hospital：

Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences

Address：

No.16 Dongzhimen Neinan Xiaojie, Dongcheng District, Beijing

Source(s) of funding：

Capitals Funds for Health Improvement and Research (No. 2024-2-4281)

Target disease：

knee osteoarthritis

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

(1)Evaluate a new type of "therapy knee pads" that can be used for daily adjuvant treatment outside of knee osteoarthritis (KOA) hospitals, and determine whether it can more effectively assist in the treatment of KOA and improve the quality of life of patients compared to placebo knee pads (knee pads prepared by the same manufacturer with the same appearance, texture, weight, and internal filling using iron sheets). (2)Through real-world clinical research data verification, our research team has established a KOA multi traditional Chinese medicine diagnostic equipment (infrared instrument, meridian instrument, tongue imaging APP+color card) combined with the National Natural Science Foundation of China project and the Science and Technology Innovation Engineering project of the Chinese Academy of Traditional Chinese Medicine to assist in syndrome differentiation and therapeutic efficacy evaluation model.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Meet the diagnostic criteria and radiographic criteria (KL grade Ⅰ to Ⅲ) for past 6 months; (2) Aged 18 to 75 years (either sex); (3) Have a clear TCM diagnosis; (4) Provide keen radiograph for past 6 months; (5) No labor pain or acupuncture treatment for KOA within 2 weeks before this study; (6) Written informed consent.

Exclusion criteria：

(1) Acute stage of knee pain and serious joint deformity; (2) History of significant knee injury; (3) History of open surgery in the index knee; (4) Diseases other than osteoarthritis that seriously affect keen joint function; (5) Have severe cardiovascular disease or cerebrovascular disease severe liver and kidney dysfunction hemopoietic system dysfunction diabetes mellitus and mental illness; (6) Pregnancy or breastfeeding; (7) Allergic constitution; (8) Resistance to the process involved in this study; (9) Unable to cooperate with treatment and post-treatment visits; (10) Incomplete medical records.

Study execute time：

From 2024-03-15

To      2026-07-01

Recruiting time：

From 2024-10-01

To      2025-12-01

Interventions：

50

Group：

Trial group

Sample size：

Intervention：

Conventional electroacupuncture treatment and Hehe therapy knee pads

Intervention code：

50

Group：

Control group

Sample size：

Intervention：

Conventional electroacupuncture treatment and Placebo knee pads

Intervention code：

Total sample size ： 100

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Institution/hospital：

Beijing Hospital

Level of the institution：

Tertiary

Outcomes：

Outcome：

Tongue coating thickness

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Meridian acupoint impedance

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Tooth marks on the tongue

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Dots on the tongue

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

visual analogue scale(VAS)

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Tongue fat or thin

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Tongue coating is greasy or rotten

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Tongue coating peeling

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Cracks on the tongue

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

A red tongue edge and tip

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Infrared image of leg meridian acupoint zoning

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Tongue color

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Ecchymosis on the tongue

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Hand holographic partitioned infrared images (including heart, liver, spleen, lungs, and kidney regions)

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Facial holographic partitioned infrared images (including heart, liver, spleen, lungs, and kidney regions)

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Short Form 12

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Infrared image of legs and temperature of acupoints

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Participate global assessment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Tongue coating color

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

N/A

Tissue：

Fate of sample 

Others

Note：

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)：

A researcher used a simple randomization method to generate a random number sequence using SPSS 27.0 software.

Blinding：

This study adopts a double-blind design ensuring that the subjects scale evaluators clinical treating physicians data collectors outcome assessors and data analysts remain blinded throughout. The double-blind condition is achievable due to the utilization of "Hehe physiotherapy knee brace" in the experimental group filled with circularly arranged energy pillars and a placebo knee brace filled with iron sheets in the control group. Both knee braces are manufactured by the same factory differing only in their internal fillings while being identical in appearance texture and weight rendering no discernible difference to the skin's sensory perception. Throughout the entire trial the subjects scale evaluators clinical treating physicians data collectors outcome assessors and data analysts remained unaware of the group allocation for each subject until the completion of treatment for all subjects and the collection of clinical data. To mitigate potential biases from operational procedures researchers who are specifically designated not involved in treatment or the collection of efficacy evaluation information unaware of the randomization scheme and properly trained will serve as scale evaluators to assess the efficacy indicators. Following the trial unblinding and data analysis will be conducted by statistical analysts (third-party statisticians).

IPD sharing：

Yes

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

The public data will publish in the form of literature on the CNKI.

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

The standard data collection form is a Case Record Form.

Data Managemen Committee：

No

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

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