UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035636 |
|---|---|
| Receipt number | R000039174 |
| Scientific Title | Effect of hybrid training on endogenous pain modulation system in patients with knee osteoarthritis |
| Date of disclosure of the study information | 2019/01/25 |
| Last modified on | 2019/08/18 13:52:02 |
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Basic information
Public title
Effect of hybrid training on endogenous pain modulation system in patients with knee osteoarthritis
Acronym
Effect of hybrid training on endogenous pain modulation system
Scientific Title
Effect of hybrid training on endogenous pain modulation system in patients with knee osteoarthritis
Scientific Title:Acronym
Effect of hybrid training on endogenous pain modulation system
Region
| Japan |
Condition
Condition
osteoarthritis of the knee
Classification by specialty
| Hematology and clinical oncology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of hybrid training during walking on endogenous pain modulation system in patients with knee osteoarthritist
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this study is change of endogenous pain modulation system after 10 minutes walk between groups with or without simultaneous hybrid muscle training.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
1. Measure diffuse infringement suppression control (DNIC) in the anterior tibialis muscle and deltoid muscle of knee pain measurement. Pain stimulus is measured after pressing the upper limb manchette on the contralateral side and making a wrist dorsal flexion.
2. Wear a hybrid training system (knee trainer) with muscle contraction level setting and walk for 10 minutes.
3. After walking, measure pervasive nociception suppression regulation (DNIC) in the tibialis anterior and deltoid muscle like before walking. Pain stimulation is similarly measured by applying pressure to the upper limb manchette on the contralateral side and performing wrist dorsal flexion of the wrist joint.
4. Calculate the average value of the obtained values and compare them before and after walking.
Equipment is worn for 10 minutes only when walking.
5. Do not attach a hybrid training system (knee trainer) 1 - 4 and take data in the same way.
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
KL classifications I-IV after the 40 th primary unilateral knee osteoarthropathy patients or healthy subjects 50 subjects who understood the purpose of this study and gained consent in writing .
For patients with primary unilateral osteoarthritis, subjects who are painful due to mechanical loading on the inner compartment to the extent possible (listening to the pain in the stairs at interview, status of bones on X - ray, Judgment from the presence or absence of inflammation) is recruited. The ratio between men and women is preferably 1: 1 if possible.
Key exclusion criteria
1.People who can not walk on their own
2.People with dementia
3.History of the knee joint of the subject side (in case of one-sided measurement) (fracture, ligament injury, meniscal lesion, surgery)
Non TKA (Total Knee Replacement) side can be applied.
4.Orthopedic current history, surgical history, past history within one year, rheumatoid arthritis,hypertension with poor control (occasionally resting blood pressure of 160/100 mmHg or more)
5.Skin and musculoskeletal disorders that are difficult to implement electrical stimulation
6.Cardiac pacemaker indwelling patient
7.Possibility of pregnancy or pregnancy
8.Those who can not use household low-frequency therapy equipment (see Commercial equipment catalog)
9.Other patients judged by the attending physician to be inappropriate for implementation.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Mayu |
| Middle name | |
| Last name | Matsuoka |
Organization
Kochi Universury
Division name
Department of Orthopaedic Surgery
Zip code
7838505
Address
Kohasu Okocho Nankokushi Kochi Japan
TEL
0888802387
jm-mayu.ok@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Mayu |
| Middle name | |
| Last name | Matsuoka |
Organization
Kochi Universury
Division name
Department of Orthopaedic Surgery
Zip code
7838505
Address
Kohasu Okocho Nankokushi Kochi Japan
TEL
0888802387
Homepage URL
jm-mayu.ok@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Universury
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Kochi university
Address
Kohasu Okocho Nankokushi Kochi Japan
Tel
0888802180
is21@kochi-u.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
| 2019 | Year | 01 | Month | 25 | 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
| 2019 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2023 | 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
| 2019 | Year | 01 | Month | 23 | Day |
Last modified on
| 2019 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039174
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