UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016548
Receipt number 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 13:37:43

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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 or person

Institute

ASCendant Inc.

Institute

Department

Personal name



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

Value
https://center6.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