UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000024838
Receipt No. R000028562
Scientific Title The effect of Okada Purifying Therapy among patients with knee pain and back pain
Date of disclosure of the study information 2016/11/15
Last modified on 2019/11/19 (Ver. 8)

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Basic information
Public title The effect of Okada Purifying Therapy among patients with knee pain and back pain
Acronym The effect of Okada Purifying Therapy among patients with knee pain and back pain
Scientific Title The effect of Okada Purifying Therapy among patients with knee pain and back pain
Scientific Title:Acronym The effect of Okada Purifying Therapy among patients with knee pain and back pain
Region
Japan

Condition
Condition patients with knee pain and back pain
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this trial is to investigate the effects of Okada Purifying Therapy towards pain, QOL and motor function, for a duration of 10 weeks among patients with knee pain and back pain
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain Scale
QOL(MQL-10)
10m walking
One leg standing with eye-opening
Body weight
Body fat
Hardness of the shoulder muscle
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
Maneuver
Interventions/Control_1 Okada Purifying Therapy
40min/day
one time/week
11 weeks
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
65 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria Residents in Nanbu City,Tottori prefecture
Individuals who have given informed consent
Key exclusion criteria Individuals with serious illness
Individuals unable to walk independently
Individuals advised to withdraw from the study by their medical doctor
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kiyoshi
Middle name
Last name Suzuki
Organization MOA Health Science Foundation
Division name Research Department
Zip code 413-0038
Address 413-0038 1-1-60 Nishiatami, Atami-shi, Shizuoka
TEL +81-557-86-0663
Email k.suzuki@mhs.or.jp

Public contact
Name of contact person
1st name Seiya
Middle name
Last name Uchida
Organization MOA Health Science Foundation
Division name Research Department
Zip code 413-0038
Address 413-0038 1-1-60 Nishiatami, Atami-shi, Shizuoka
TEL +81-557-86-0663
Homepage URL
Email seiya-u@mhs.or.jp

Sponsor
Institute MOA Health Science Foundation
Institute
Department

Funding Source
Organization MOA Health Science Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization MOA Health Science Foundation, Institutional Review Board
Address 1-1-60 Nishiatami, Atami-shi, Shizuoka
Tel +81-557-86-0663
Email hata@mhs.or.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
2016 Year 11 Month 15 Day

Related information
URL releasing protocol https://ci.nii.ac.jp/naid/40021599871
Publication of results Partially published

Result
URL related to results and publications https://ci.nii.ac.jp/naid/40021599871
Number of participants that the trial has enrolled 12
Results 
Participation in the weekly biofield therapy classroom, led to reduction in the measurement of pain. Statistically significant changes were observed in reduction of pain scale measurements, increase in QOL scores, and reduction in the measures of the degree of Locomo. The duration of participants ability to stand on the right leg with opened eyes, increased significantly. All participants were satisfied with the classroom, 11 out of 12 participants requested continuation of the classroom.
Results date posted
2019 Year 11 Month 19 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Twelve participants (3 males / 8 females) with knee pain or/and low back pain participated. The average age was 71.3 years (67-74 years old).
Participant flow 
The biofield therapy classroom was held eleven times in total, once every week. Okada purifying therapy (weekly, treatment for 40 minutes) and other health related activity (biweekly, exercise or flower arrangement, 20 minutes per session) were conducted.
Adverse events 
No
Outcome measures 
Their pain scales, MQL 10, Locomo 25, life style score
10 meters walking, standing with one leg with opened eyes, shoulder muscle hardness, body weight, body fat.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 11 Month 15 Day
Date of IRB
2016 Year 11 Month 15 Day
Anticipated trial start date
2016 Year 11 Month 15 Day
Last follow-up date
2018 Year 02 Month 01 Day
Date of closure to data entry
2018 Year 03 Month 01 Day
Date trial data considered complete
2018 Year 03 Month 01 Day
Date analysis concluded
2018 Year 06 Month 01 Day

Other
Other related information NO

Management information
Registered date
2016 Year 11 Month 15 Day
Last modified on
2019 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028562