UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053342 |
|---|---|
| Receipt number | R000060860 |
| Scientific Title | Immediate effects of pressure stimulation during bicycling exercise on knee pain in patients with knee osteoarthritis. |
| Date of disclosure of the study information | 2024/01/15 |
| Last modified on | 2024/01/13 13:21:08 |
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Basic information
Public title
Immediate effects of pressure stimulation during bicycling exercise on knee pain in patients with knee osteoarthritis.
Acronym
Immediate effects of pressure stimulation during bicycling exercise on knee pain in patients with knee osteoarthritis.
Scientific Title
Immediate effects of pressure stimulation during bicycling exercise on knee pain in patients with knee osteoarthritis.
Scientific Title:Acronym
Immediate effects of pressure stimulation during bicycling exercise on knee pain in patients with knee osteoarthritis.
Region
| Japan |
Condition
Condition
osteoarthritis of the knee
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the immediate effects of pressure stimulation during bicycling exercise on anterior knee joint pain and infrapatellar fat pad body dynamics in elderly patients with osteoarthritis of the knee.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tenderness threshold of the knee joint on the affected side
Key secondary outcomes
Flexibility of the fat body under the knee cap - Japanese Orthopaedic Association Joint range of motion test: knee joint flexion and extension - Knee joint extension and flexion muscle strength - Stage of knee osteoarthritis - Obesity: Body Mass Index (BMI) - Ability to perform activities of daily living: Functional Independence Measure (FIM) - At the time of intervention Pain in the knee joint on the affected side - Catastrophic thoughts of pain: Pain catastrophizing scale (PCS) - Central sensitisation syndrome: CentralSensitization Inventory (CSI)9
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Combination of pressure stimulation and bicycling exercise.
The equipment was a bicycle ergometer (Cat eye, ECMD100). Duration 10 min. Saddle height was set so that the knee joint was in slight (10) flexion when the pedals were down. The load is lightest load. Posture is comfortable, gripping the handlebars in front. Cadence is at comfortable speed.
Interventions/Control_2
cycling exercise
The equipment was a bicycle ergometer (Cat eye, ECMD100). Duration 10 min. Saddle height was set so that the knee joint was in slight (10) flexion when the pedals were down. The load is lightest load. Posture is comfortable, gripping the handlebars in front. Cadence is at comfortable speed.
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who visited the Department of Orthopaedic Surgery at Yanagawa Rehabilitation Hospital and were diagnosed with osteoarthritis of the knee and who were positive for the Hoffa pain provocation test. -Men and women aged 65 years or older at the time of obtaining consent -Patients whose free-will consent to participate in the study can be obtained in writing from the individual.
Key exclusion criteria
(1) Patients with a history of obvious central nervous system disease or peripheral neuropathy (2) Patients with a history of depression or other psychiatric disorders (3) Patients with a history of knee joint trauma or surgery (4) Patients with rheumatic diseases (5) Patients with skin diseases
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Kaneko |
Organization
International University of Health and Welfare International University of Health and Welfare Graduate School
Division name
Department of Health and Medical Sciences, Physical Therapy
Zip code
831-8501
Address
137-1 Enokizu, Okawa, Fukuoka, Japan
TEL
0944-89-2000
hkaneko@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Kogakura |
Organization
International University of Health and Welfare Graduate School
Division name
Graduate School of Health and Welfare Master's Degree in Health and Medical Sciences
Zip code
831-8501
Address
137-1 Enokizu, Okawa, Fukuoka, Japan
TEL
0944-89-2000
Homepage URL
23s1068@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare, International University of Health and Welfare, Graduate School
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare, International University of Health and Welfare, Graduate School
Address
137-1 Enokizu, Okawa, Fukuoka, Japan
Tel
0944-89-2000
23s1068@g.iuhw.ac.jp
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
| 2024 | Year | 01 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2024 | Year | 01 | Month | 13 | Day |
Last modified on
| 2024 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060860
