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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017275
Receipt No. R000020048
Scientific Title Comparison of the BackJoy SitSmart Relief and Spine Buddy LT1 HC chair supports on neck and back pain short-term
Date of disclosure of the study information 2015/04/26
Last modified on 2015/04/25

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Basic information
Public title Comparison of the BackJoy SitSmart Relief and Spine Buddy LT1 HC chair supports on neck and back pain short-term
Acronym Support pad impact on neck and back pain
Scientific Title Comparison of the BackJoy SitSmart Relief and Spine Buddy LT1 HC chair supports on neck and back pain short-term
Scientific Title:Acronym Support pad impact on neck and back pain
Region
North America

Condition
Condition Support pad
Classification by specialty
Medicine in general Geriatrics Rehabilitation medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Measure how different chair pads performed using the Nordic Musculoskeletal Questionnaire
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes NMQ score
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 They were then randomized to sit in a stationary office chair for 12 minutes under one of four conditions: office chair only (control group), BackJoy SitSmart Relief and chair, freezer-cooled Spine Buddy LT1 HC and chair, or microwave-heated Spine Buddy LT1 HC and chair.
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 college students, provide written informed consent, 5 feet 5 inches to 5 feet 10 inches tall, and they must weight over 100 pounds.
Key exclusion criteria Diagnosis of any health condition where they cannot feel pain, sweaty or damp clothing, wearing minimal clothing (e.g., a sports bra).
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name John Ward, DC, MA, MS
Organization Texas Chiropractic College
Division name Research
Zip code
Address 5912 Spencer Highway, Pasadena, TX 77505
TEL 2819985704
Email jward@txchiro.edu

Public contact
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, Pasadena, TX 77505
TEL 2819985704
Homepage URL
Email jward@txchiro.edu

Sponsor
Institute TCC
Institute
Department

Funding Source
Organization TCC
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
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
2015 Year 04 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
Results
Results: The main effect of time across the whole sample was statistically significant for neck (p=0.000), upper back (p=0.032), and lower back (p=0.000) pain; however, there was no statistically significant interaction effect between intervention and time. Thus, as long as the participant sat down and rested they improved similarly no matter which group they were in.  
Conclusions: The results of this research suggest the addition of an extra support to an office chair did not reduce pain any greater than resting in a chair by itself short-term.  
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
2015 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2015 Year 04 Month 23 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 25 Day
Last modified on
2015 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020048

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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