UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000032603 |
|---|---|
| Receipt number | R000037141 |
| Scientific Title | the effect of music therapy on serum IL-6 levels in patient with rheumatoid arthritis. |
| Date of disclosure of the study information | 2018/05/16 |
| Last modified on | 2024/01/15 19:40:26 |
* 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
the effect of music therapy on serum IL-6 levels in patient with rheumatoid arthritis.
Acronym
the effect of music therapy on serum IL-6 levels in patient with rheumatoid arthritis.
Scientific Title
the effect of music therapy on serum IL-6 levels in patient with rheumatoid arthritis.
Scientific Title:Acronym
the effect of music therapy on serum IL-6 levels in patient with rheumatoid arthritis.
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effect of music therapy by measuring serum cytokines before and after the music therapy in patients with rheumatoid arthritis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Various cytokines including serum IL-6 measured before and after music therapy
Key secondary outcomes
CRP, RF, MMP 3, DAS 28 - CRP, questionnaire (pain VAS, general health VAS, doctor VAS, HADS, HAQ, SF - 8) before and after music therapy
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
| Other |
Interventions/Control_1
music therapy
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient with rheumatoid arthritis
Key exclusion criteria
Patient without rheumatoid arthritis
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Fujita |
Organization
Kurashiki sweet hospital
Division name
Department of rihabiritation
Zip code
7100016
Address
3542-1 Nakasho Kurashiki Okayama Japan
TEL
086-463-7111
sfujita@wakokai.com
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Fujita |
Organization
Kurashiki sweet hospital
Division name
Department of rihabiritation
Zip code
7100016
Address
3542-1 Nakasho Kurashiki Okayma japan
TEL
086-463-7111
Homepage URL
sfujita@wakokai.com
Sponsor or person
Institute
Kurashiki sweet hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurashiki sweet hospital
Address
3542-1 Nakasho Kurashiki Okayama Japan
Tel
086-463-7111
wyamamoto@wakokai.com
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
| 2018 | Year | 05 | Month | 16 | Day |
Related information
URL releasing protocol
https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000032603
Publication of results
Published
Result
URL related to results and publications
https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000032603
Number of participants that the trial has enrolled
16
Results
Before and after music therapy,the P - VAS changed from an average of 24 to 20 (p= 0.235),the F-VAS changed from an average of 22 to an average of 16 (p= 0.117),an improvement trend was seen It was. As a serologic evaluation,MMP-3 showed a significant decrease from average 95.7 to 85.9 (p<0.001),TNF-alpha averaged 75.7pg/ml to 50.0pg/ml,and other reductions of inflammatory cytokines were also observed recognized.
Results date posted
| 2024 | Year | 01 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
For the subjects,16 RA patients participating in our RA classes (3 men,13 females) against an average of 74.8 years (65-83 years old).
Participant flow
Blood was drawn before music therapy, 45 minutes of music therapy was performed, and blood was drawn again after music therapy.
Adverse events
Because antibodies are measured by blood sampling outside of normal clinical practice, this involves a new invasive procedure outside of normal clinical practice.
Since the blood was drawn outside of normal practice, neurological symptoms and infection may be present, although this is unlikely.
Outcome measures
Pain (Pain-Visual Analogue Scale, P-VAS: 0-100 high and poor), general patient (General Health-VAS, GH-VAS), mood (Feeling-VAS, F-VAS) assessment and serum CRP, MMP-3, IL-6, TNF-alpha
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 12 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 15 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 01 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 15 | Day |
Last modified on
| 2024 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037141
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
