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Recruitment status Completed
Unique ID issued by UMIN UMIN000013322
Receipt No. R000015548
Official scientific title of the study 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

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Basic information
Official scientific title of the study Immediate Effects of Upper Thoracic Spine Manipulation on Hypertensive Individuals.
Title of the study (Brief title) 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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 John Ward, DC, MA, MS
Organization Texas Chiropractic College
Division name Research
Address 5912 Spencer Highway, Pasadena, TX 77505
TEL 281-998-5704
Email jward@txchiro.edu

Public contact
Name of contact person John Ward
Organization Texas Chiropractic College
Division name Research
Address 5912 Spencer Highway, Pasadena, TX 77505
TEL 281-998-5704
Homepage URL http://www.txchiro.edu/
Email jward@txchiro.edu

Sponsor
Institute Texas Chiropractic College
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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

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

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
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.
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015548


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