UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052262 |
|---|---|
| Receipt number | R000059644 |
| Scientific Title | The Acute Effects of Thoracic Spine Manipulation on Vertebral Alignment. |
| Date of disclosure of the study information | 2023/09/21 |
| Last modified on | 2023/09/21 05:56:17 |
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Basic information
Public title
The Acute Effects of Thoracic Spine Manipulation on Vertebral Alignment.
Acronym
The Acute Effects of Thoracic Spine Manipulation on Vertebral Alignment.
Scientific Title
The Acute Effects of Thoracic Spine Manipulation on Vertebral Alignment.
Scientific Title:Acronym
The Acute Effects of Thoracic Spine Manipulation on Vertebral Alignment.
Region
| Europe |
Condition
Condition
manual therapy, physiotherapy
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
effects of manual therapy on the thoracic spine in athletes without any postural problems and pain on the spinal segments.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acute kinematic effect of manipulation practices occurs only in practice region not other vertebral segments in spine.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
thoracal spinal manipulation
Interventions/Control_2
Sham Manipulation
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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
Being between the ages 18 and 35
Being a healthy, professional, male athlete
Key exclusion criteria
Not having congenital or acquired diseases related to the upper and lower extremities
Not having any disease or orthopedic operation affecting the spine
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Hayri |
| Middle name | Baran |
| Last name | YOSMAOGLU |
Organization
Baskent University
Division name
Faculty of Health Sciences Department of Physiotherapy
Zip code
06
Address
eskisehir yolu 20.km Ankara
TEL
+905327318630
baran79@gmail.com
Public contact
Name of contact person
| 1st name | Hayri |
| Middle name | Baran |
| Last name | YOSMAOGLU |
Organization
Baskent University
Division name
Faculty of Health Scieces
Zip code
06
Address
eskisehir yolu 20km Ankara
TEL
+905327318630
Homepage URL
baran79@gmail.com
Sponsor or person
Institute
Baskent University Faculty of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Baskent University
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
Baskent University
Address
Eskisehir yolu 20.km Baglica / Ankara
Tel
+903122466678
sbfak@baskent.edu.tr
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
| 2023 | Year | 09 | Month | 21 | Day |
Related information
URL releasing protocol
review processing
Publication of results
Unpublished
Result
URL related to results and publications
review processing
Number of participants that the trial has enrolled
28
Results
Significant difference has been found in intervention grup compared to sham.
Results date posted
| 2023 | Year | 09 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healty individuals
Participant flow
28 participants
Adverse events
no adverse event
Outcome measures
stereophotogrammetric surface analysis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 21 | Day |
Last modified on
| 2023 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059644
