UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021095 |
|---|---|
| Receipt number | R000024335 |
| Scientific Title | Spine Buddy LT2 H/C ergonomic chair support short-term impact on spine pain and flexion-relaxation phenomenon |
| Date of disclosure of the study information | 2016/02/19 |
| Last modified on | 2016/02/19 00:08:54 |
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Basic information
Public title
Spine Buddy LT2 H/C ergonomic chair support short-term impact on spine pain and flexion-relaxation phenomenon
Acronym
Ergonomic chair pad impact
Scientific Title
Spine Buddy LT2 H/C ergonomic chair support short-term impact on spine pain and flexion-relaxation phenomenon
Scientific Title:Acronym
Ergonomic chair pad impact
Region
| North America | Australia |
Condition
Condition
Participants sat against an ice-pack cooled ergonomic chair support pad.
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The impact of an ergonomic chair support pad was measured with the Nordic Musculoskeletal Questionnaire (NMQ) and the surface EMG Flexion-Relaxation Phenomenon test. The intent of the study was to determine if the Spine Buddy LT2 H/C ergonomic chair support impacted these variables for participants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nordic Musculoskeletal Questionnaire form, and lower back motor unit action potential pattern during the surface EMG Flexion-Relaxation Phenomenon (FRP) test. The FRP test measures lower erector spinae muscle activity during a functional toe-touch task and is a common tool to measure back muscle coordination.
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The Spine Buddy LT 2 H/C ergonomic chair support pad was connected to an office chair. Participants sat in the chair for 12 minutes at the end of their college student day (after approximately 6 hours of sitting in classrooms). The impact of the ergonomic pad on a musculoskeletal pain survey and a functional surface EMG test was monitored.
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 student 18-65 years of age, provide written informed consent, and between 5'5" and 5'10"
Key exclusion criteria
Diagnosis of any blood vessel or neurological disorder that would result in a decreased ability to perceive pain, sweaty or damp clothing worn by participants, or wearing a sports bra or similar minimalist clothing that would put most of their back directly in contact with the cooled Spine Buddy product
Target sample size
32
Research contact person
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, Pasadena TX
TEL
2819985704
jward@txchiro.edu
Public contact
Name of contact person
| 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
TEL
2819985704
Homepage URL
jward@txchiro.edu
Sponsor or person
Institute
Texas Chiropractic College
Institute
Department
Personal name
Funding Source
Organization
na
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 02 | Month | 19 | 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: Participants demonstrated a statistically significant decrease in neck (p=0.005) and low back (p=0.000) pain/discomfort using the product. The extension and flexion phases of the FRP test showed that participants were approaching a more pain-free profile.
Conclusions: In this study, the addition of an ice-pack cooled chair support product to an office chair demonstrated an ability to lower neck and low back pain or discomfort and normalize FRP test results 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 | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 02 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 19 | Day |
Last modified on
| 2016 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024335
