UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057273 |
|---|---|
| Receipt number | R000065464 |
| Scientific Title | The Effect of Adding Transcutaneous Electrical Nerve Stimulation (TENS) to Static Bicycle Intervention on Inflammatory Cytokine Levels (IL-6), Range of Motion (ROM), and Functional Ability in Patients with Knee Osteoarthritis |
| Date of disclosure of the study information | 2025/03/12 |
| Last modified on | 2025/03/12 22:50:25 |
* 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
The Effect of Adding Transcutaneous Electrical Nerve Stimulation (TENS) to Static Bicycle Intervention on Inflammatory Cytokine Levels (IL-6), Range of Motion (ROM), and Functional Ability in Patients with Knee Osteoarthritis
Acronym
BEST-KOA
Scientific Title
The Effect of Adding Transcutaneous Electrical Nerve Stimulation (TENS) to Static Bicycle Intervention on Inflammatory Cytokine Levels (IL-6), Range of Motion (ROM), and Functional Ability in Patients with Knee Osteoarthritis
Scientific Title:Acronym
BEST-KOA
Region
| Asia(except Japan) |
Condition
Condition
this study aims to investigate the effect of adding TENS to static bicycle exercise in KOA patients. The study will evaluate the impact on inflammatory cytokine IL-6 levels, range of motion (ROM), and functional ability.
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effects of static bicycle exercise and transcutaneous electrical nerve stimulation (TENS) therapy on inflammatory cytokine levels and range of motion in patients with knee osteoarthritis. The objective is to determine whether these interventions can improve functional ability and reduce inflammation, leading to better quality of life for patients.
Basic objectives2
Others
Basic objectives -Others
To evaluate the effects of static bicycle exercise and Transcutaneous Electrical Nerve Stimulation (TENS) on inflammatory cytokine levels, range of motion (ROM), and functional ability in patients with knee osteoarthritis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IL-6 Levels: Measured using ELISA from venous blood samples.
Range of Motion (ROM): Measured using a goniometer in degrees. Flexion: 135, Extension: 0.
Functional Ability: Assessed using the WOMAC Index (higher scores indicate worse function).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Static Bicycle
Interventions/Control_2
Static Bicycle and TENS
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
| 45 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diagnosed with grade II-III KOA
Aged 45-74 years
Completed 8 intervention sessions
Key exclusion criteria
- Received other treatments outside the study protocol
- Comorbidities like cardiopulmonary disease, neurological disorders, or post-knee surgery
- Pacemaker users
- Active joint infections
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | yulisar |
| Middle name | asfia |
| Last name | rasak |
Organization
Biomedical science program study, Universitas Hasanuddin, Makassar
Division name
Biomedical science
Zip code
90922
Address
Btn Minasaupa d4/12
TEL
085159939922
ulliasfia24@gmail.com
Public contact
Name of contact person
| 1st name | yulisar asfia |
| Middle name | |
| Last name | rasak |
Organization
biomedical science
Division name
biomedical science
Zip code
90922
Address
makassar
TEL
085159939922
Homepage URL
ulliasfia24@gmail.com
Sponsor or person
Institute
Universitas Hasanuddin
Institute
Department
Personal name
Funding Source
Organization
-
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
Faculty of Health
Address
Tamalanrea
Tel
0411 585658
fkm.unhas@gmail.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 | 03 | Month | 12 | 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
Results
Results date posted
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 14 | 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 | 03 | Month | 12 | Day |
Last modified on
| 2025 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065464
