UMIN-CTR Clinical Trial

Basic information
Public title	Randomized trial of the impact of a sacroiliac belt on patients with low back pain following a 5-day manual labor task
Acronym	Randomized trial of the impact
Scientific Title	Randomized trial of the impact of a sacroiliac belt on patients with low back pain following a 5-day manual labor task
Scientific Title:Acronym	Randomized trial of the impact
Region	North America Europe

Condition
Condition	Support belt
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 support belt on low back pain.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	lumbar spine pain on a 0-10 Numeric Rating Scale (NRS), spine and thigh discomfort on a Nordic Musculoskeletal Questionnaire (NMQ), and completion of a toe-touch surface EMG Flexion Relaxation Phenomenon (FRP) test.
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Wearing the Serola sacroiliac support belt to decrease low back pain during a strenuous activity over 5 days.
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	55 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Low back or sacroiliac joint pain 2) Provided written informed consent 3) Able to lift 15 pounds 4) 18 years to 65 years of age
Key exclusion criteria	1) Pregnant 2) Spine surgery 3) Lower limb surgery 4) Twisted ankle 5) Skin disease affecting the lower limbs 6) Significant arthritis to impair motion 7) Sunburn
Target sample size	35

Research contact person
Name of lead principal investigator	1st name John Middle name Last name Ward
Organization	Texas Chiropractic College
Division name	Research
Zip code	77505
Address	5912 Spencer Highway
TEL	281-236-4908
Email	jward@txchiro.edu

Public contact
Name of contact person	1st name John Middle name Last name Ward
Organization	Texas Chiropractic College
Division name	Research
Zip code	77505
Address	5912 Spencer Highway
TEL	2812364908
Homepage URL
Email	jward@txchiro.edu

Sponsor
Institute	n/a
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	Texas Chiropractic College
Address	5912 Spencer Highway
Tel	2814871170
Email	jward@txchiro.edu

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	2022 Year 03 Month 01 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	33
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 01 Month 01 Day
Date of IRB	2021 Year 01 Month 01 Day
Anticipated trial start date	2021 Year 01 Month 15 Day
Last follow-up date	2022 Year 01 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	2022 Year 02 Month 21 Day
Last modified on	2022 Year 02 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053591