UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022947 |
|---|---|
| Receipt number | R000026452 |
| Scientific Title | Pain relief using myofascial continuous compression stimulation is produced by a change of pressure-pain threshold in individuals with knee osteoarthritis |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2016/06/30 08:26:49 |
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Basic information
Public title
Pain relief using myofascial continuous compression stimulation is produced by a change of pressure-pain threshold in individuals with knee osteoarthritis
Acronym
Pain relief using myofascial continuous compression stimulation is produced by a change of pressure-pain threshold in individuals with knee osteoarthritis
Scientific Title
Pain relief using myofascial continuous compression stimulation is produced by a change of pressure-pain threshold in individuals with knee osteoarthritis
Scientific Title:Acronym
Pain relief using myofascial continuous compression stimulation is produced by a change of pressure-pain threshold in individuals with knee osteoarthritis
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to reveal the mechanism of pain relief produced by myofacial continuous compression stimulation in individuals with knee osteoarthritis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain (immediately after intervention)
Key secondary outcomes
Pressure-pain threshold (immediately after intervention)
Muscle spasm (immediately after intervention)
General rating of change (immediately after intervention)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Myofacial continuous compression stimulation was performed on the anterior and distal portion of the medial thigh. Intervention was one time. The compression stress was increased gradually and stopped just before the patient experienced pain. Based on the degree of compression stress at this time, the pressure for massage for each patient was determined. The time of continuous compression was 5 min.
Interventions/Control_2
Stimulation was added on the anterior and distal portion of the medial thigh, but the compression force was kept in almost 0.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were as follows: a positive diagnosis of knee osteoarthritis by an orthopedist based on plain radiography, knee pain either at rest or while walking, and age >= 50 years.
Key exclusion criteria
The exclusion criteria were as follows: definitive neurological disorders, inability to respond to the questions unaided because of cognitive impairment, or the presence of skin disease
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryo Tanaka |
Organization
Hiroshima International University
Division name
Department of Rehabilitation, Faculty of Rehabilitation
Zip code
Address
555-36, Kurose-gauendai, Higashi-hiroshima, Hiroshima
TEL
0823-70-4914
r-tanaka@hs.hirokoku-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Tanaka |
Organization
Hiroshima International University
Division name
Department of Rehabilitation, Faculty of Rehabilitation
Zip code
Address
555-36, Kurose-gauendai, Higashi-hiroshima, Hiroshima
TEL
0823-70-4914
Homepage URL
r-tanaka@hs.hirokoku-u.ac.jp
Sponsor or person
Institute
Hiroshima International University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima International University
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
Address
Tel
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
| 2016 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 30 | Day |
Last modified on
| 2016 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026452
