UMIN-CTR Clinical Trial

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
Email	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
Email	m-wachi@pt-si.aino.ac.jp

Sponsor
Institute	Kanazawa Orthopaedic & Sports Medicine Clinic
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052841