UMIN-CTR Clinical Trial

Basic information
Public title	Is online exercise at home more effective than hydrotherapy and physiotherapy in patients with non-specific chronic low back pain? A randomized clinical trial
Acronym	Treatments for low back pain
Scientific Title	Is online exercise at home more effective than hydrotherapy and physiotherapy in patients with non-specific chronic low back pain? A randomized clinical trial
Scientific Title:Acronym	Treatment methods for low back pain
Region	Asia(except Japan)

Condition
Condition	Low back pain
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Is online exercise at home more effective than hydrotherapy and physiotherapy in patients with non-specific chronic low back pain?
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain intensity
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Exercise
Interventions/Control_2	hydrotherapy
Interventions/Control_3	physiotherapy
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	25 years-old <=
Age-upper limit	45 years-old >=
Gender	Male and Female
Key inclusion criteria	The inclusion criteria were a history of pain for at least three months, a minimum score of two on the visual analog scale (VAS), willingness to participate in any randomly selected treatment groups, and receiving full doses of the Covid-19 vaccine.
Key exclusion criteria	The exclusion criteria were the presence of the lumbar disc herniation, acute stage of lumbar disc protrusion, systematic diseases (such as cardiovascular) or any condition which contraindicated, spinal surgery, fractures or inflammatory diseases of the spine, or any pathophysiological disorder, body mass index (BMI) more than normal rate, having any intervention in the last two months, taking medical drugs, and failure to participate in the treatment sessions.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Mohammad Middle name Last name Bayattork
Organization	University of Hormozgan,
Division name	Faculty of Humanities Science
Zip code	7916193145
Address	Faculty of Humanities Science, University of Hormozgan, Bandar Abbas, Iran
TEL	989155521005
Email	mohammadbayat82@gmail.com

Public contact
Name of contact person	1st name Mohammad Middle name Last name Bayattork
Organization	University of Hormozgan
Division name	Faculty of Humanities Science
Zip code	7916193145
Address	Faculty of Humanities Science, University of Hormozgan, Bandar Abbas, Iran
TEL	+989155521005
Homepage URL
Email	mohammadbayat82@gmail.com

Sponsor
Institute	University of Hormozgan
Institute
Department

Funding Source
Organization	University of Hormozgan
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	University of Hormozgan
Address	University of Hormozgan, Bandar Abbas, Iran
Tel	989155521005
Email	mohammadbayat82@gmail.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	2021 Year 12 Month 30 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	60
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 02 Month 10 Day
Date of IRB	2021 Year 08 Month 01 Day
Anticipated trial start date	2021 Year 08 Month 01 Day
Last follow-up date	2021 Year 11 Month 01 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 12 Day
Last modified on	2021 Year 12 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052896