UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056526 |
|---|---|
| Receipt number | R000064594 |
| Scientific Title | The effect of adding hold relax to shortwave diathermy (SWD) and manual therapy in knee joint osteoarthritis patients |
| Date of disclosure of the study information | 2024/12/20 |
| Last modified on | 2024/12/20 18:00:06 |
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Basic information
Public title
The effect of adding hold relax exercises to shortwave diathermy (SWD) and manual therapy on reducing pain and increasing activity of daily living (ADL) in knee joint osteoarthritis patients
Acronym
The effect of HR to SWD and MT on reducing pain and increasing ADL in OA knee patients
Scientific Title
The effect of adding hold relax to shortwave diathermy (SWD) and manual therapy in knee joint osteoarthritis patients
Scientific Title:Acronym
The effect of HR to SWD and MT 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 research aims to evaluate the effect of additional hold relax exercises to SWD procedures and manual therapy on reducing pain and increasing ADL
patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
reducing pain and increasing ADL ability
Key secondary outcomes
there were significant changes between the study groups
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
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
Hold relax exercises, shortwave diathermy and manual therapy
Interventions/Control_2
shortwave diathermy and manual therapy
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 2-3 knee OA based on the Kellgren and Lawrence classification.
Aged 45-59 years and 60-74 years.
Both men and women.
Experienced knee pain and limitations in daily activities.
Must also receive shortwave diathermy (SWD) and manual therapy according to the hospital protocol.
Key exclusion criteria
Participants with a history of cardiorespiratory disease, such as using a pacemaker.
Neurological disorders that result in the inability to feel hot temperatures.
Participants who have undergone procedures such as total knee replacement or total knee arthroplasty.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Dina Fitriyah Nurin |
| Middle name | |
| Last name | Rahmadi |
Organization
Hasanuddin University
Division name
Biomedical Science Study Program
Zip code
90245
Address
Perintis Kemerdekaan Street, KM 10
TEL
+6281340730602
dinafitriyah46@gmail.com
Public contact
Name of contact person
| 1st name | Dina Fitriyah Nurin |
| Middle name | |
| Last name | Rahmadi |
Organization
Hasanuddin University
Division name
Biomedical Science Study Program
Zip code
90245
Address
Perintis Kemerdekaan Street, KM 10
TEL
+6281340730602
Homepage URL
dinafitriyah46@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 Research Ethics Committee of the 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 Uiversity Hospital (Makassar city, Indonesia)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 20 | 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 | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 20 | Day |
Last modified on
| 2024 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064594
