UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046964 |
|---|---|
| Receipt number | R000053591 |
| Scientific Title | Randomized trial of the impact of a sacroiliac belt on patients with low back pain following a 5-day manual labor task |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2022/02/21 22:28:59 |
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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
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
jward@txchiro.edu
Sponsor or person
Institute
n/a
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053591
