Measure the Effects of Specific Thoracic Chiropractic Adjustments on Blood Pressure and Pulse Rate
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ClinicalTrials.gov Identifier: NCT01591967 |
Recruitment Status :
Completed
First Posted : May 4, 2012
Last Update Posted : May 4, 2012
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Condition or disease | Intervention/treatment | Phase |
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Hypertension | Device: Activator IV Adjusting Instrument | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 290 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Controlled Trial to Measure the Effects of Specific Thoracic Chiropractic Adjustments on Blood Pressure and Pulse Rate |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | February 2010 |
Actual Study Completion Date : | March 2010 |

Arm | Intervention/treatment |
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No Intervention: Control
Control -- no intervention
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No Intervention: Placebo w/ sham
Sham intervention with the adjusting tool turned "off"
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Experimental: Activator treatment
Treatment with Activator
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Device: Activator IV Adjusting Instrument
Activator (http://www.activator.com/products-page/) adjustment effects on BP and PR
Other Names:
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- The purpose of this randomized controlled trial (RCT) was to measure the effects of specific thoracic (T5 to T1) chiropractic adjustments on BP and PR in a larger sample size of both normotensive and hypertensive humans. [ Time Frame: Baseline, pre-adjustment, post-adjustment ]OBJECTIVE: Previous studies on the effects of chiropractic treatment on blood pressure (BP) and pulse rate (PR) have reported decreases in both systolic and diastolic BP, as well as PR. However, many of those studies have been criticized for various study flaws, and accused of drawing erroneous conclusions, due to small sample size and various methodological concerns. The purpose of this randomized controlled trial (RCT) was to measure the effects of specific thoracic (T5 to T1) chiropractic adjustments on BP and PR in a larger sample size of both normotensive and hypertensive humans.

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Subjects were invited to participate in accordance with the Guidelines for Chiropractic Quality Assurance and Practice Parameters: proceedings of the Mercy Center Consensus Conference, Gaithersburg, MD, 1993, Aspen Publishers Inc.
Additionally and specifically for this RCT:
- Both male and female subjects age 18 years and older were invited to participate
- Subjects must not be pregnant
- Subjects must not have any recent or current fractures of the arms or legs
- Subjects must not have any visceral or abdominal condition such that being in the prone position would be detrimental to their health
- Subjects must not have any known primary cancers of the spine or spinal column, nor any secondary metastatic process of the spine or spinal column
- Subjects must not be under the influence of drugs or alcohol
- Subjects must not have vertigo or any other imbalance condition
- Subjects must not have any arm or leg prosthetic device
- Subjects must be able to understand spoken and/or written Spanish and/or English
Exclusion Criteria:

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591967
Principal Investigator: | Steven D. Roffers, DC | Spinal Missions, Inc., LLC |
Responsible Party: | Dr. Steven D. Roffers, Director of Research, Spinal Missions, Inc., LLC |
ClinicalTrials.gov Identifier: | NCT01591967 |
Other Study ID Numbers: |
SM001 |
First Posted: | May 4, 2012 Key Record Dates |
Last Update Posted: | May 4, 2012 |
Last Verified: | May 2012 |
Chiropractic Blood pressure Pulse Rate Thoracic |
Hypertension Vascular Diseases Cardiovascular Diseases |