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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016548
Receipt No. R000019206
Scientific Title Single arm clinical trial of Mud therapy for relief pain in older people in Shogawa town.
Date of disclosure of the study information 2015/02/16
Last modified on 2015/02/16

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Basic information
Public title Single arm clinical trial of Mud therapy for relief pain in older people in Shogawa town.
Acronym Single arm clinical trial of Mud therapy.
Scientific Title Single arm clinical trial of Mud therapy for relief pain in older people in Shogawa town.
Scientific Title:Acronym Single arm clinical trial of Mud therapy.
Region
Japan

Condition
Condition people complain of pain in lower back or legs
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Thirty-Second Chair Stand, Timed up and Go,Brief Pain Inventory Short Form,blood pressure, heart beat, amylase in saliva,ADL
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Thirty-Second Chair Stand, Timed up and Go
Key secondary outcomes Brief Pain Inventory Short Form,blood pressure, heart beat, amylase in saliva,ADL

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
Device,equipment
Interventions/Control_1 Treatment periods are set at week 1 (period 1) and week 6 (period 2) of the intervention period. All participants receive fango therapy three times in each treatment period. A washout period of 4 week is defined as the time between the two treatment periods.
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
50 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Complaint of pain in lower back or legs. Live near the Salon in San-raku-en Resort Hotel in Sho-gawa town in Toyama prefecture.
Key exclusion criteria Take NSAIDs or received a nerve block injection to relieve lower body pains prior to or during the intervention.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryoji Hirota
Organization Kochi Medical School
Division name Department of Environmental Medicine
Zip code
Address Kohasu, Oko, Nankoku, Kochi 783-8505, Japan.
TEL 088-880-2407
Email hirotar@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ichiro Miyano
Organization Kochi Medical School
Division name Department of Public Health
Zip code
Address Kohasu, Oko, Nankoku, Kochi 783-8505, Japan.
TEL 088-880-2412
Homepage URL
Email miyano@kochi-u.ac.jp

Sponsor
Institute ASCendant Inc.
Institute
Department

Funding Source
Organization BioFango Association
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Mizuno Owada
Name of secondary funder(s) ASCendant Inc.

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 三楽園

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Mean age was 66.9 +/-5.3 years. Mean blood pressure was slightly lower thanreference value of the same age (systolic BP was 134.3 +/-16.9 (mmHg), diastolicBP was 88.5 +/-10.8 (mmHg)). Most reported painful parts were leg (50.0%) andlower back (50.0%). Analysis of CS-30 score showed an increase of 1.63 (form13.23 at baseline to 14.86, p=0.038) at the end of treatment period 1. A slightdecrease (from 8.68 s to 8.26 s) in TUG score was observed, but not significantstatistically (p=0.423). Almost all items from BPI-J, which measure painseverity and pain interference, were improved significantly after treatmentperiod 1(p=0.004~0.025). We compared outcome measures between baseline and week6. A 2.97-score increase (from 13.23 at baseline to 16.20) in CS-30 test at theend of treatment period 2 was statistically significant at (p=0.000).Improvement was observed also with TUG test as the score decreasedsignificantly (from 8.68 s at baseline to 7.82 s, p=0.015). Six out of 9 itemsfrom BPI-J showed a trend toward better improvement from pain (p=0.004~0.017).
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 01 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 19 Day
Last follow-up date
2014 Year 01 Month 31 Day
Date of closure to data entry
2014 Year 02 Month 28 Day
Date trial data considered complete
2014 Year 02 Month 28 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 02 Month 16 Day
Last modified on
2015 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019206

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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