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

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Device: Activator IV Adjusting Instrument

• Registration Number: NCT01591967
• Lead Sponsor: Spinal Missions, Inc., LLC

Brief Summary

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.

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-02
• Study Completion: 2010-03
• Study First Submitted: 2012-04-30
• Status Verified: 2012-05
• Study First Submitted QC: 2012-05-02
• Last Update Submitted: 2012-05-02
• Study First Posted: 2012-05-04
• Last Update Posted: 2012-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Activator treatment	Activator IV Adjusting Instrument	Treatment with Activator

Primary Outcome Measures

Name	Time	Method
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.	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.