UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000054485
Receipt number R000062235
Scientific Title Effect of 6weeks combined protocol (Thai massage and core exercises) on pain, functional disability and core endurance in patients with sacroiliac joint disorder
Date of disclosure of the study information 2024/05/26
Last modified on 2024/05/26 02:09:47

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Basic information

Public title

Effect of 6weeks combined protocol (Thai massage and core exercises) on pain, functional disability and core endurance in patients with sacroiliac joint disorder

Acronym

Effect of 6weeks combined protocol (Thai massage and core exercises) on pain, functional disability and core endurance in patients with sacroiliac joint disorder

Scientific Title

Effect of 6weeks combined protocol (Thai massage and core exercises) on pain, functional disability and core endurance in patients with sacroiliac joint disorder

Scientific Title:Acronym

Effect of 6weeks combined protocol (Thai massage and core exercises) on pain, functional disability and core endurance in patients with sacroiliac joint disorder

Region

Asia(except Japan)


Condition

Condition

pre-post

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Effect of 6weeks combined protocol (Thai massage and core exercises) on pain, functional disability and core endurance in patients with sacroiliac joint disorder

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

pain

Key secondary outcomes

functional disability; core endurance


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

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

core stability

Interventions/Control_2

Thai massage and core exercises

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

25 years-old <=

Age-upper limit

50 years-old >=

Gender

Male

Key inclusion criteria

male gender; being in the age range of 25 to 50 years; positive three tests from Gilet; Gaenselen, FABER; Standing Forward Bending; Compression tests

Key exclusion criteria

fracture; pain spreading below the knee; no back pain due to other reasons.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Gholamali
Middle name
Last name Ghasemi

Organization

Khorasgan

Division name

isfahan

Zip code

53566333

Address

khorasgan

TEL

009873666464

Email

gh.ghasemi@spr.ui.ac.ir


Public contact

Name of contact person

1st name Gholamali
Middle name
Last name Ghasemi

Organization

Khorasgan

Division name

Isfahan

Zip code

455536

Address

Khorasgan

TEL

009866364674

Homepage URL


Email

gh.ghasemi@spr.ui.ac.ir


Sponsor or person

Institute

University of Tehran

Institute

Department

Personal name



Funding Source

Organization

no funding

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Khorasgan universit

Address

Isfahan

Tel

009809837645

Email

www.mohammmmad27m@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

2024 Year 05 Month 26 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

20

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

Terminated

Date of protocol fixation

2023 Year 03 Month 01 Day

Date of IRB

2023 Year 03 Month 02 Day

Anticipated trial start date

2023 Year 03 Month 10 Day

Last follow-up date

2023 Year 06 Month 09 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2024 Year 05 Month 26 Day

Last modified on

2024 Year 05 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062235


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name