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

Spinal Missions, Inc., LLC

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Device: Activator IV Adjusting Instrument

Study type: Interventional

Funder types: Other

Identifiers

NCT01591967

SM001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 290 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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290 participants in 3 patient groups

Control

No Intervention group

Description:

Control -- no intervention

Placebo w/ sham

No Intervention group

Description:

Sham intervention with the adjusting tool turned "off"

Activator treatment

Experimental group

Description:

Treatment with Activator

Treatment:

Device: Activator IV Adjusting Instrument