UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pain relief using myofascial continuous compression stimulation is produced by a change of pressure-pain threshold in individuals with knee osteoarthritis
Title of the study (Brief title)	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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Ryo Tanaka
Organization	Hiroshima International University
Division name	Department of Rehabilitation, Faculty of Rehabilitation
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	Ryo Tanaka
Organization	Hiroshima International University
Division name	Department of Rehabilitation, Faculty of Rehabilitation
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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