UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000058310 |
|---|---|
| Receipt number | R000066664 |
| Scientific Title | Effect of Tuina Therapy on Improving Frailty Status in Older Adults with Knee Osteoarthritis: A Randomized Clinical Trial |
| Date of disclosure of the study information | 2025/06/29 |
| Last modified on | 2025/06/29 18:39:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of Tuina Therapy on Improving Frailty Status in Older Adults with Knee Osteoarthritis: A Randomized Clinical Trial
Acronym
ETIFSOKOA - RCT
Scientific Title
Effect of Tuina Therapy on Improving Frailty Status in Older Adults with Knee Osteoarthritis: A Randomized Clinical Trial
Scientific Title:Acronym
ETIFSOKOA - RCT
Region
| Asia(except Japan) |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Geriatrics | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether Tuina therapy can improve frailty status in older adults with knee osteoarthritis (KOA) by evaluating changes in frailty indices, physical function, and quality of life through a randomized clinical trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the change in frailty status measured by the Fried Frailty Phenotype Score (FFPS) at the end of the 12-month intervention period.
Key secondary outcomes
Key secondary outcomes include the changes in Frailty Index (FI), gait speed, 6-minute walk distance (6MWD) and health-related quality of life evaluated by SF-36 at the end of the one-year intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Tuina group: Standardized Tuina therapy (rubbing, kneading, acupressure on knee - related acupoints like Dubi, Zusanli; 2 - 3 times/week, ~30 minutes/session, 1 year) + individualized quadriceps training (2 - 5 times/week) + individualized NSAIDs (ibuprofen/celecoxib, intermittent/continuous as needed)
Interventions/Control_2
Non - Tuina group: No Tuina therapy + individualized quadriceps training (2 - 5 times/week) + individualized NSAIDs (ibuprofen/celecoxib, intermittent/continuous as needed)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Age is 60 years old or older.
(2) Knee osteoarthritis (KOA) meets the American College of Rheumatology diagnostic criteria: knee pain in the past 1 month, osteophytes present, and at least one of age is 45 years old or older, morning stiffness is less than 30 minutes, or bone friction sound during knee movement.
(3) No prior KOA treatment history.
(4) No acute joint infection/inflammation or joint deformity.
(5) No severe comorbidities (e.g., heart failure, malignant tumors).
(6) No mental illness/cognitive impairment; has sufficient understanding and communication abilities.
(7) No tuina therapy contraindications (e.g., skin damage, fractures, severe osteoporosis, coagulation disorders).
(8) Participant and family members understand the study and sign informed consent.
Key exclusion criteria
(1) Age is younger than 60 years old.
(2) KOA does not meet the American College of Rheumatology diagnostic criteria.
(3) Has received prior KOA treatment.
(4) With acute joint infection/inflammation or joint deformity.
(5) With severe comorbidities (e.g., heart failure, malignant tumors).
(6) With mental illness/cognitive impairment; lacks sufficient understanding and communication abilities.
(7) With tuina therapy contraindications (e.g., skin damage, fractures, severe osteoporosis, coagulation disorders).
(8) Participant or family members do not understand the study or refuse to sign informed consent.
Target sample size
624
Research contact person
Name of lead principal investigator
| 1st name | Xi |
| Middle name | |
| Last name | Yang |
Organization
Hospital of Chengdu University of Traditional Chinese Medicine
Division name
Massage Department
Zip code
610072
Address
No.39, Shierqiao Road, Jinniu District, Chengdu City, Sichuan Province, China
TEL
0086-13880420331
cicifunnyang123@163.com
Public contact
Name of contact person
| 1st name | Xi |
| Middle name | |
| Last name | Yang |
Organization
Hospital of Chengdu University of Traditional Chinese Medicine
Division name
Massage Department
Zip code
610072
Address
No.39, Shierqiao Road, Jinniu District, Chengdu City, Sichuan Province, China
TEL
0086-13880420331
Homepage URL
cicifunnyang123@163.com
Sponsor or person
Institute
Hospital of Chengdu University of Traditional Chinese Medicine
Institute
Department
Personal name
Funding Source
Organization
Hospital of Chengdu University of Traditional Chinese Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Medical Ethics Committee of the Hospital of Chengdu University of Traditional Chinese Medicine
Address
No.39, Shierqiao Road, Jinniu District, Chengdu City, Sichuan Province, China
Tel
8602887783139
SCTCMGCP@163.COM
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
624
Results
This RCT of 624 elderly KOA patients showed Tuina therapy for 1 year significantly reduced FFPS and FI (both P<0.001 vs baseline), increased gait speed, 6MWD, and SF-36 scores (all P<0.001 vs baseline), and outperformed the non-Tuina group in all metrics (P<0.001 to P=0.018), confirming its efficacy in improving frailty and quality of life.
Results date posted
| 2025 | Year | 06 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 29 | Day |
Last modified on
| 2025 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066664
