UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039723
Receipt No. R000045303
Scientific Title Central pain modulation and exercise-induced hypoalgesia in Japanese patients with knee and hip osteoarthritis.
Date of disclosure of the study information 2020/03/06
Last modified on 2020/06/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Central pain modulation and exercise-induced hypoalgesia in Japanese patients with knee and hip osteoarthritis.
Acronym Central pain modulation in osteoarthritis patients.
Scientific Title Central pain modulation and exercise-induced hypoalgesia in Japanese patients with knee and hip osteoarthritis.
Scientific Title:Acronym Central pain modulation in osteoarthritis patients.
Region
Japan

Condition
Condition Knee and hip osteoarthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to analyse of conditions of central pain modulation and investigate exercise-induced hypoalgesia in Japanese patients with knee and hip osteoarthritis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 1) Subjective pain, 2) Quantitative sensory testing
Key secondary outcomes Physical function

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Standard treatment and exercise (walking)
Three times per week for 3 months
Interventions/Control_2 Standard treatment
For 3 months
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

Not applicable
Gender Male and Female
Key inclusion criteria At least 1 on the Kellgren/Lawrence scale for knees or hips

Experienced near-daily knee or hip pain (ie, pain that was present for more than 4 days per week and was rated as 2 or higher on a 0 to 10 scale) for at least 6 months

Self-reported knee or hip pain was the primary musculoskeletal complaint at the time of recruitment

Aged 40 years or older
Key exclusion criteria Having Systemic inflammatory disease

Cognitive impairment affecting the ability to cooperate with testing

Leg pain referred from the lumbar disease

Experienced serious medical comorbidities (eg, congestive heart failure, cerebrovascular disease, cancer)

Using centrally acting medications such as opioid
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takako
Middle name
Last name Matsubara
Organization Kobe Gakuin University
Division name Graduate School of Rehabilitation
Zip code 651-2180
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe 651-2180, JAPAN
TEL (078)974-1551
Email matsubar@reha.kobegakuin.ac.jp

Public contact
Name of contact person
1st name Takako
Middle name
Last name Matsubara
Organization Kobe Gakuin University
Division name Graduate School of Rehabilitation
Zip code 651-2180
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe 651-2180, JAPAN
TEL (078)974-1551
Homepage URL
Email matsubar@reha.kobegakuin.ac.jp

Sponsor
Institute Kobe Gakuin University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Maehara Orthopedic Rehabilitation Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kobe Gakuin University
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe 651-2180, JAPAN
Tel (078)974-4127
Email ethic@reha.kobegakuin.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 神戸学院大学(兵庫県)

Other administrative information
Date of disclosure of the study information
2020 Year 03 Month 06 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 06 Month 05 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2020 Year 10 Month 31 Day
Date of closure to data entry
2020 Year 10 Month 31 Day
Date trial data considered complete
2020 Year 11 Month 01 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2020 Year 03 Month 06 Day
Last modified on
2020 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045303

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.