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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032887
Receipt No. R000037500
Scientific Title Serola belt impact on spine pain, regional thigh discomfort, and erector spinae flexion-relaxation phenomenon following a manual labor task
Date of disclosure of the study information 2018/06/06
Last modified on 2018/06/06

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Basic information
Public title Serola belt impact on spine pain, regional thigh discomfort, and erector spinae flexion-relaxation phenomenon following a manual labor task
Acronym Support belt impact on spine pain.
Scientific Title Serola belt impact on spine pain, regional thigh discomfort, and erector spinae flexion-relaxation phenomenon following a manual labor task
Scientific Title:Acronym Support belt impact on spine pain.
Region
North America

Condition
Condition To have some participants wear a sacroiliac support belt and measure its impact on low back pain, erector spinae surface EMG, and functional disability.
Classification by specialty
Medicine in general Orthopedics Rehabilitation medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Measure the impact of the Serola sacroiliac support belt on low back pain, low back discomfort, and lower back surface EMG attributes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Lower back pain, spine and thigh discomfort, and lower back surface EMG.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Wear a sacroiliac support belt.
Interventions/Control_2
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
65 years-old >=
Gender Male and Female
Key inclusion criteria Written informed consent, no low back pain for control group #1, control group #2 and experimental group must have low back pain.
Key exclusion criteria pregnant, spine or lower limb surgery, twisted ankle, skin disease, sunburn.
Target sample size 48

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name John Ward
Organization Texas Chiropractic College
Division name Research
Zip code
Address 5912 Spencer Highway
TEL 281-236-4908
Email jward@txchiro.edu

Public contact
1st name of contact person
1st name
Middle name
Last name John Ward
Organization Texas Chiropractic College
Division name Research
Zip code
Address 5912 Spencer Highway
TEL 281-236-4908
Homepage URL
Email jward@txchiro.edu

Sponsor
Institute Texas Chiropractic College
Institute
Department

Funding Source
Organization Serola company
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 06 Month 06 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
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
2018 Year 06 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 06 Day
Last modified on
2018 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037500

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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