Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Measure the Effects of Specific Thoracic Chiropractic Adjustments on Blood Pressure and Pulse Rate

This study has been completed.
Sponsor:
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
History of Changes
  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:

U.S. FDA Resources

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:
  • Activator adjusting instrument
  • http://www.activator.com/products-page/

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
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:

  1. Both male and female subjects age 18 years and older were invited to participate
  2. Subjects must not be pregnant
  3. Subjects must not have any recent or current fractures of the arms or legs
  4. Subjects must not have any visceral or abdominal condition such that being in the prone position would be detrimental to their health
  5. 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
  6. Subjects must not be under the influence of drugs or alcohol
  7. Subjects must not have vertigo or any other imbalance condition
  8. Subjects must not have any arm or leg prosthetic device
  9. 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

Sponsors and Collaborators
Spinal Missions, Inc., LLC
Investigators
Principal Investigator: Steven D. Roffers, DC Spinal Missions, Inc., LLC
  More Information

No publications provided

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 March 03, 2015