UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046301 |
|---|---|
| Receipt number | R000052841 |
| Scientific Title | effects of deep thermotherapy in chronic low back pain |
| Date of disclosure of the study information | 2021/12/07 |
| Last modified on | 2022/06/08 18:06:49 |
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Basic information
Public title
effects of deep thermotherapy in chronic low back pain
Acronym
effects of deep thermotherapy in chronic low back pain
Scientific Title
effects of deep thermotherapy in chronic low back pain
Scientific Title:Acronym
effects of deep thermotherapy in chronic low back pain
Region
| Japan |
Condition
Condition
chronic low back pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
effects of deep thermotherapy in chronic low back pain
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS in 1 hour from treatment
Key secondary outcomes
EMG, muscle stiffness, ROM in 1 hour from treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
15 min deep thermotherapy in lower back
Interventions/Control_2
sham
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
patients who have chronic low back pain for more than 3 month
Key exclusion criteria
patients who have severe complications of cardiovascular disease, renal disease, respiratory disease or other disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | michio |
| Middle name | |
| Last name | wachi |
Organization
Biwako Professional University of Rehabilitation
Division name
Department of Physical Therapy
Zip code
527-0145
Address
967 Kitasaka-cho, Higashiomi
TEL
0749-46-2311
m-wachi@pt-si.aino.ac.jp
Public contact
Name of contact person
| 1st name | Michio |
| Middle name | |
| Last name | Wachi |
Organization
Biwako Professional University of Rehabilitation
Division name
Department of Physical Therapy
Zip code
527-0145
Address
967 Kitasaka-cho, Higashiomi
TEL
0749-46-2311
Homepage URL
m-wachi@pt-si.aino.ac.jp
Sponsor or person
Institute
Kanazawa Orthopaedic & Sports Medicine Clinic
Institute
Department
Personal name
Funding Source
Organization
none
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
Kanazawa Orthopaedic & Sports Medicine Clinic
Address
8-8-1 Ono, Shiga 520-3016
Tel
077-553-0007
k.riha-workshop@kanazawaseikei.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
びわこリハビリテーション専門職大学、金沢整形外科クリニック、布留整形クリニック
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
Results
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
| 2021 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 07 | Day |
Last modified on
| 2022 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052841
