UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016965 |
|---|---|
| Receipt number | R000019695 |
| Scientific Title | The impact of the Spine Buddy stretch pad on supine participants with and without low back pain. |
| Date of disclosure of the study information | 2015/03/30 |
| Last modified on | 2015/03/30 10:50:11 |
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Basic information
Public title
The impact of the Spine Buddy stretch pad on supine participants with and without low back pain.
Acronym
Stretch pad impact on the spine
Scientific Title
The impact of the Spine Buddy stretch pad on supine participants with and without low back pain.
Scientific Title:Acronym
Stretch pad impact on the spine
Region
| North America |
Condition
Condition
Stretch pad
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to measure how this pad impacted neck extension and lower torso traction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of cervical extension and lumbar torso traction.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) 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
The Spine Buddy support pad for the spine.
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
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) they provided their informed written consent
2) adults between the heights of 5'5" and 5'10"
3) they had low back pain if they were in the
experimental group
Key exclusion criteria
1) orthostatic hypotension
2) neck or back surgery
3) whiplash
4) in a wheel chair
5) possessing a physical impairment that
would make it unsafe for them to lay
down on a patient table
Target sample size
20
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
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
jward@txchiro.edu
Sponsor or person
Institute
Spine Buddy
Institute
Department
Personal name
Funding Source
Organization
Spine Buddy
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
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 | 03 | Month | 30 | 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 addition of the support pad resulted in an 8.8 deg and 4.2 deg increase in cervical extension in head neutral for the healthy and LBP groups, respectively.
The pad resulted in a 14.7 deg and 9.2 deg increase in cervical extension in a 45 deg laterally flexed to the right position for the healthy and LBP groups, respectively. The pad did not result in a statistically significant change in lower torso traction.
Conclusions: The results from this study demonstrate that the Spine Buddy; stretch pad increases cervical neck extension momentarily, but does not traction the lower torso to a relevant level.
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
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 12 | Month | 15 | Day |
Date analysis concluded
| 2015 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 30 | Day |
Last modified on
| 2015 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019695
