UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016965
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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 Spine Buddy
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019695

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.