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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052896


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name