UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024838 |
|---|---|
| Receipt number | 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 18:00:15 |
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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
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
seiya-u@mhs.or.jp
Sponsor or person
Institute
MOA Health Science Foundation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028562
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