Measure the Effects of Specific Thoracic Chiropractic Adjustments on Blood Pressure and Pulse Rate
This study has been completed.
Sponsor:
Spinal Missions, Inc., LLC
Information provided by (Responsible Party):
Dr. Steven D. Roffers, Spinal Missions, Inc., LLC
ClinicalTrials.gov Identifier:
NCT01591967
First received: April 30, 2012
Last updated: May 2, 2012
Last verified: May 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this randomized controlled trial (RCT) is 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Device: Activator IV Adjusting Instrument |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by Spinal Missions, Inc., LLC:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 290 |
| Study Start Date: | January 2010 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control
Control -- no intervention
|
|
|
No Intervention: Placebo w/ sham
Sham intervention with the adjusting tool turned "off"
|
|
|
Experimental: Activator treatment
Treatment with Activator
|
Device: Activator IV Adjusting Instrument
Activator (http://www.activator.com/products-page/) adjustment effects on BP and PR
Other Names:
|
Detailed Description:
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) is 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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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:
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591967
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591967
Sponsors and Collaborators
Spinal Missions, Inc., LLC
Investigators
| Principal Investigator: | Steven D. Roffers, DC | Spinal Missions, Inc., LLC |
More Information
| Responsible Party: | Dr. Steven D. Roffers, Director of Research, Spinal Missions, Inc., LLC |
| ClinicalTrials.gov Identifier: | NCT01591967 History of Changes |
| Other Study ID Numbers: | SM001 |
| Study First Received: | April 30, 2012 |
| Last Updated: | May 2, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Spinal Missions, Inc., LLC:
|
Chiropractic Blood pressure Pulse Rate Thoracic |
ClinicalTrials.gov processed this record on September 23, 2016