UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046358 |
|---|---|
| Receipt number | R000052896 |
| 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 |
| Date of disclosure of the study information | 2021/12/30 |
| Last modified on | 2021/12/12 14:49:55 |
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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
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
mohammadbayat82@gmail.com
Sponsor or person
Institute
University of Hormozgan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052896
