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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022947
Receipt No. 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

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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
Email 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
Email r-tanaka@hs.hirokoku-u.ac.jp

Sponsor
Institute Hiroshima International University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026452

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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