UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013322 |
|---|---|
| Receipt number | R000015548 |
| Scientific Title | Immediate Effects of Upper Thoracic Spine Manipulation on Hypertensive Individuals. |
| Date of disclosure of the study information | 2014/03/05 |
| Last modified on | 2014/03/04 00:13:44 |
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Basic information
Public title
Immediate Effects of Upper Thoracic Spine Manipulation on Hypertensive Individuals.
Acronym
Spinal manipulation impact on hypertensive patients
Scientific Title
Immediate Effects of Upper Thoracic Spine Manipulation on Hypertensive Individuals.
Scientific Title:Acronym
Spinal manipulation impact on hypertensive patients
Region
| North America |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1)Determine how chiropractic thoracic spine manipulation impacts blood pressure of patients with hypertension. 2)Determine how chiropractic thoracic spine manipulation impacts electrocardiograph readings of patients with hypertension. 3)Determine how chiropractic thoracic spine manipulation impacts pulse oximetry of patients with hypertension.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Measure blood pressure, electrocardiograms, and pulse oximetry of patients with hypertension before and after they receive thoracic spine manipulation from a chiropractor to confirm this intervention is safe for patients who may have back pain and be hypertensive.
Key secondary outcomes
Notice if there is a difference amongst participants on and off cardiovascular drugs after they have received chiropractic spinal manipulation.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Chiropractic thoracic spine manipulation was performed on study participants as the intervention. This procedure is used commonly for patients that have back pain. We were observing if thoracic spine manipulation impacted patients with hypertension differently than patients without hypertension (our previous research). Thoracic spine manipulation is often used to help reduce pain of patients with mid-back pain.
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
No fractures
Key exclusion criteria
no smoking
Target sample size
50
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
281-998-5704
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
281-998-5704
Homepage URL
http://www.txchiro.edu/
jward@txchiro.edu
Sponsor or person
Institute
Texas Chiropractic College
Institute
Department
Personal name
Funding Source
Organization
Texas Chiropractic College
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
United States of America
Other related organizations
Co-sponsor
na
Name of secondary funder(s)
na
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Immediate Effects of Upper Thoracic Spine Manipula
Org. issuing International ID_1
Texas Chiropractic College
Study ID_2
na
Org. issuing International ID_2
na
IND to MHLW
na
Institutions
Institutions
Texas Chiropractic College
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 05 | 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: Within-group changes in PR interval and QRS duration demonstrated that the atria were transiently less active post-spine manipulation and the ventricles were more active post-spine manipulation, however the changes were clinically minimal.
Conclusion: The results of this study, and the limited existing normotensive thoracic-specific spine manipulation research in this field, suggest cardiovascular physiology, short-term, is not affected by upper thoracic spine spine manipulation in hypertensive individuals to a clinically 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
| 2013 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 04 | Day |
Last modified on
| 2014 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015548
