HypertensionPhase 1NCT01591967
Measure the Effects of Specific Thoracic Chiropractic Adjustments on Blood Pressure and Pulse Rate
A Phase 1 study testing Activator IV Adjusting Instrument in people with Hypertension, run by Spinal Missions, Inc., LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Activator IV Adjusting Instrument
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Mar 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
None listed.
About this study
Official title: A Randomized Controlled Trial to Measure the Effects of Specific Thoracic Chiropractic Adjustments on Blood Pressure and Pulse Rate
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Activator IV Adjusting Instrument
- Keywords
- Chiropractic, Blood pressure, Pulse Rate, Thoracic
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activator IV Adjusting InstrumentDevice
Also called Activator adjusting instrument, http://www.activator.com/products-page/
Activator (http://www.activator.com/products-page/) adjustment effects on BP and PR
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control -- no intervention |
| Placebo w/ sham | No intervention | Sham intervention with the adjusting tool turned "off" |
| Activator treatment | Experimental | Treatment with Activator Receives: Device: Activator IV Adjusting Instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Baseline, pre-adjustment, post-adjustment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startJan 2010
- Primary completionFeb 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spinal Missions, Inc., LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Steven D. Roffers, Spinal Missions, Inc., LLC
- Investigators
- Steven D. Roffers, DC, Principal investigator, Spinal Missions, Inc., LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591967
- Sponsor's protocol ID
- SM001
- Status last verified
- May 2012
- First submitted
- 30 Apr 2012
- Last updated
- 4 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Measure the Effects of Specific Thoracic Chiropractic Adjustments on Blood Pressure and Pulse Rate
- ClinicalTrials.gov ID
- NCT01591967
- Acronym / sponsor ID
- SM001
- Conditions
- Hypertension
- Keywords
- Chiropractic, Blood pressure, Pulse Rate, Thoracic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Spinal Missions, Inc., LLCUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 4 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control -- no intervention |
| Placebo w/ sham | No intervention | –Sham intervention with the adjusting tool turned "off" |
| Activator treatment | Experimental | Device: Activator IV Adjusting InstrumentTreatment with Activator |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activator IV Adjusting InstrumentAlso: Activator adjusting instrument, http://www.activator.com/products-page/Activator (http://www.activator.com/products-page/) adjustment effects on BP and PR | Device | Activator treatment |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven D. Roffers, DC principal investigator
Spinal Missions, Inc., LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Activator IV Adjusting Instrument in people with Hypertension, run by Spinal Missions, Inc., LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2012.