UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057258 |
|---|---|
| Receipt number | R000065452 |
| Scientific Title | The Effect of Adding Neuromuscular Electrical Stimulation (NMES) in Static Bicycle Intervention in Knee Osteoarthritis Patients |
| Date of disclosure of the study information | 2025/03/11 |
| Last modified on | 2025/03/11 15:01:59 |
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Basic information
Public title
The Effect of Adding Neuromuscular Electrical Stimulation (NMES) in Static Bicycle Intervention on Inflammatory Cytokine Levels (IL-6), Range Of Motion (ROM) and Functional Ability in Knee Osteoarthritis Patients.
Acronym
The Effect of NMES to SB on reducing IL-6 levels and increasing ROM, functional ability in OA Knee Patients
Scientific Title
The Effect of Adding Neuromuscular Electrical Stimulation (NMES) in Static Bicycle Intervention in Knee Osteoarthritis Patients
Scientific Title:Acronym
The Effect of NMES to SB in OA Knee Patients
Region
| Asia(except Japan) |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to determine the effect of the addition NMES in static bicycle intervention on inflammatory cytokine levels (IL-6), ROM knee joint flexion and functional ability in knee osteorathritis patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
reduce interleukin 6 (IL-6) cytokine levels, improve functional ability and knee joint flexion ROM after 4 weeks of intervention in each treatment group
Key secondary outcomes
there was a significant difference between the study groups in improving functional ability and ROM flexion of the knee joint. however, the decrease in IL-6 levels only occurred in the static bicycle intervention group added with NMES.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Static Bicycle
Interventions/Control_2
Static Bicycle and Neuromuscular Electrical Stimulation (NMES)
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
had been diagnosed with grade 2-3 OA knee dextra or sinistra based on the Kellgren and Lawrence classification through radiological examination (x-ray) and diagnosis by an orthopedic doctor. Recruitment of research samples was based on inclusion criteria, including 45-74 years old, both men and women, experiencing functional limitations, knee range of motion (ROM) and quadriceps muscle weakness in the extremities experiencing knee OA
Key exclusion criteria
Exclusion criteria included having a history of other diseases such as cardiorespiratory disease, neurological and other knee joint disorders other than knee osteoarthritis, receiving intra-articular injections within the previous three months or surgery, using pacemakers or internal metal materials, having infections or other inflammatory conditions and having contractures in the muscles around the knee joint.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Wardatun Wahdaniyah |
| Middle name | |
| Last name | Rasidi |
Organization
Hasanuddin University
Division name
Biomedical Science Study Program
Zip code
90245
Address
Sahabat Raya Street, tamalanrea, Sulawesi selatan
TEL
+6285145205857
wardatunwahdaniyah16@gmail.com
Public contact
Name of contact person
| 1st name | Wardatun Wahdaniyah |
| Middle name | |
| Last name | Rasidi |
Organization
Hasanuddin University
Division name
Biomedical Science Study Program
Zip code
90245
Address
Sahabat Raya Street, tamalanrea, Sulawesi selatan
TEL
+6285145205857
Homepage URL
wardatunwahdaniyah16@gmail.com
Sponsor or person
Institute
self funding
Institute
Department
Personal name
Funding Source
Organization
self funding
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 Health Research Ethics Commission (KEPK) Faculty of Public Health, Hasanuddin University.
Address
Perintis Kemerdekaan Street, KM 10
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
Hasanuddin University Hospital (Makassar city, Indonesia)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 11 | 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 | 12 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 07 | 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 | 11 | Day |
Last modified on
| 2025 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065452
