PrehypertensionHOTNCT02605551
Hypertension and Osteopathic Treatment
A study testing Osteopathic Manipulative Therapy and Lifestyle Modification in people with Prehypertension and Hypertension, run by Larkin Community Hospital.
Trial summary
The goal of this study is to demonstrate the use of osteopathic manipulative therapy (OMT) in the effective management of hypertension. The investigators hypothesize that by addressing/correcting somatic dysfunctions with OMT, the sympathetic overdrive that could be the root cause of the elevation in blood pressure… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prehypertension, Hypertension, Osteopathic Manipulation
- What is being tested?
- Osteopathic Manipulative Therapy and Lifestyle Modification
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2015to 30 Mar 2016
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Blood pressure meeting the criteria for pre-hypertension (130-139/85-89) or stage 1 hypertension (140-159/90-99) at two different instances
- Otherwise healthy adult patients consenting to study participation
Who cannot join
- Presence of co-morbid renal or liver disease
- medication regimen of more than one anti-hypertensive medication
- Presence of pre-existing heart disease, CAD (coronary artery disease), severe stenotic valvular disease, CHF (congestive heart failure), cardiomyopathy
- Presence of condition that would make application of OMT protocol impossible
- Pregnancy
- Patient refusal
About this study
Official title: The Utilization of Osteopathic Manipulation (OMT) as an Adjunct Therapy in the Treatment of Hypertension
The goal of this study is to demonstrate the use of osteopathic manipulative therapy (OMT) in the effective management of hypertension. The investigators hypothesize that by addressing/correcting somatic dysfunctions with OMT, the sympathetic overdrive that could be the root cause of the elevation in blood pressure will be downregulated. If this is the case, then an effective therapy for hypertension could indeed be regular OMT treatment. This could also result in the avoidance of potentially harmful antihypertensive medications which comprise a majority of the current therapeutic strategy in the treatment of hypertension (along with lifestyle modification). A third implication of the results of this project could be a reduction in the progression of this disease. Under the current standard of care, a majority of hypertensive patients only experience a worsening of the disease over time under the current therapeutic guidelines.
Read the detailed description
Approximately 60% of American adult population has prehypertension or hypertension. Subgroups such as African Americans, elderly, low-socioeconomic-status, and the overweight population, are disproportionately affected. Larkin Community Hospital (LCH) and its affiliated sites provide a great number of patients in these particular subgroups and this represents an ideal institution to study this tremendous health issue. Hypertension is a progressive disease and it has been shown·that, later in life, patients with borderline hypertension will progress at a much higher rate to Stage 1 or 2 hypertension as compared with normotensive population. The Framingham study has been demonstrated after 26 years of follow up, that 71% of patients with high-normal blood pressure (systolic, 130-139 mm Hg; diastolic, 85-89) developed clinical hypertension later in life. The Tecumseh blood pressure study has shown that subjects aged between 20 and 40 years old with borderline hypertension (average BP 130.7/93.8) have had significantly higher childhood (average age 6 years) BP levels compared with normotensive ones, further illustrating the propensity of this disease to progress. Also, the bell-shaped curve of blood pressure in the general population shows that the largest group of people will have blood pressures in the prehypertensive range, showing what a large proportion of the population would be affected by advances in the management of this disease.
Osteopathic manipulative therapy (OMT) is a therapeutic modality utilized by osteopathic physicians to address somatic dysfunctions in the musculoskeletal system. Somatic dysfunctions are abnormalities in musculoskeletal tissue texture and intervertebral joint dysfunction. Close associations between spinal vertebrae and the autonomic nervous system via the sympathetic trunk and ganglia are believed to be one of the mechanisms by which musculoskeletal system changes can affect other organs (somatovisceral reflex). Indeed, osteopathic philosophy posits that OMT has a distinct effect beyond the musculoskeletal system. Additionally, the autonomic and lymphatic systems and their effects upon the function of the cardiovascular system have been extensively studied. OMT has been shown by Stiles to significantly decrease both mortality and morbidity of patients with cardiovascular dysfunctions. Rogers et al. have also reported that OMT has been demonstrated to be of significant value in some patients with coronary insufficiency.
The bulk of the sympathetic nervous system lies adjacent to the thoracic spine as well as the superior lumbar spine. Particularly, the sympathetic innervation of the heart has its origins in cord segments T1-T6, with synapses occurring between pre-and post-ganglionic fibers in the upper thoracic and/or cervical ganglia. As previously discussed, alterations in the spinal mechanics and the presence of somatic dysfunctions in these regions of the spine have been theorized to alter the function of the autonomic nervous system originating from these regions. Specific cardiovascular effects of these dysfunctions are increased heart rate, increased contractility, increased cardiac work-load, and increased total peripheral resistance. To provide further evidence of the link between the musculoskeletal system and the cardiovascular system, it was demonstrated that patients with Travell triggerpoints in the right pectoralis muscle may be prone to periods of supraventricular tachyarrhythmias. When these trigger points are the etiologies of the arrhythmias, the arrhythmia disappears when the trigger point is effectively treated.
The goal of this study is to demonstrate the use of OMT in the effective management of hypertension. The investigators hypothesize that by addressing/correcting somatic dysfunctions with OMT, it will downregulate the sympathetic overdrive that could be the root cause of the elevation in blood pressure. If this is the case, then an effective therapy for hypertension could indeed be regular OMT treatment. This could also result in the avoidance of potentially harmful antihypertensive medications which comprise a majority of the current therapeutic strategy in the treatment of hypertension (along with lifestyle modification). A third implication of the results of this project could be a reduction in the progression of this disease. As discussed above, a majority of hypertensive patients only experience a worsening of the disease over time under the current therapeutic guidelines.
- Being tested
- Osteopathic Manipulative Therapy, Lifestyle Modification
- Medical subject headings
- Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TherapyProcedure or surgery
Also called OMT, OMM, NMM, Osteopathic Manipulation Treatment
All OMT techniques will be performed by osteopathic physicians who will have received training specific to this protocol prior to study initiation. All used techniques will be slow moving and gentle to augment rest and relaxation, promote autonomic balance, and release fascial contractures. The techniques that will be used in this protocol are:
- OM Occipitomastoid release technique
- Sub-Occipital Release Technique
- Rib Raising Technique
- Rotatory stimulation of posterior Chapman's Reflexes
- Lymphatic Pumps and Effleurage: (Pedal Pump of Dalrymple)
Lifestyle ModificationBehavioural
Patients will be counseled on healthy behaviors such as regular exercise, weight loss, and a healthy diet
| Study group | Role | What they receive |
|---|---|---|
| OMT Group | Active comparator | During the initial visit, the subject will have his BP recorded manually by the osteopathic physician in a standardized fashion. The subject will then undergo the OMT protocol and have his BP recorded again immediately afterwards. This will represent the conclusion of the initial visit. There will be 2 subsequent visits about 2-3 weeks apart that will be identical to this visit. Following the third visit, the next follow-up will be 2 months afterwards. However, the patient will only have his BP checked, and will not undergo an OMT treatment. The final visit will be another 2 months afterwards and will also be a simple BP check with no OMT treatment. The principles of lifestyle modification (diet/exercise/weight loss) will also be discussed at each visit. Receives: Procedure: Osteopathic Manipulative Therapy; Behavioral: Lifestyle Modification |
| Control Group | Placebo comparator | Patients in this arm will only receive lifestyle modification recommendations at each visit, along with a BP check. No antihypertensive medication changes will be made unless indicated by the guidelines. Receives: Behavioral: Lifestyle Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Participants will have an initial BP measurement, followed by measurements at 2, 4 and 6 weeks (both before and after OMT treatment performed at those visits). Then, they will have a simple BP check at 10 weeks and finally at 14 weeks. The goal of these measurements is to ascertain whether or not there is a change of baseline systolic/diastolic BP with serial OMT treatments
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study start1 Apr 2015 (estimated)
- Primary completion30 Mar 2016
- Study completion30 Mar 2016
Why it stopped: Study Period Ended / Not Completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for PrehypertensionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larkin Community Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Miami Beach Community Health Center
- Responsible party
- Sponsor
- Investigators
- Rohit S Mehra, DO, MPH, MS, Principal investigator, Larkin Community HospitalDavid Stuckey, DO, Study director, Larkin Community HospitalScott E Spagnolo-Hye, DO, MS, Study chair, Larkin Community Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605551
- Sponsor's protocol ID
- LCH-2-022015
- Acronym
- HOT
- Status last verified
- Oct 2023
- First submitted
- 7 Nov 2015
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Daiber WF: Disorders of the Kidneys in Hoag JM (ed) Osteopathic Medicine. New York, McGraw-Hill, 1969, Ch 39, PP644-5
Wang Y, Wang QJ. The prevalence of prehypertension and hypertension among US adults according to the new joint national committee guidelines: new challenges of the old problem. Arch Intern Med. 2004 Oct 25;164(19):2126-34. doi: 10.1001/archinte.164.19.2126.
PubMed 15505126Julius S, Schork MA. Borderline hypertension--a critical review. J Chronic Dis. 1971 Mar;23(10):723-54. doi: 10.1016/0021-9681(71)90005-1. No abstract available.
PubMed 4933751Leitschuh M, Cupples LA, Kannel W, Gagnon D, Chobanian A. High-normal blood pressure progression to hypertension in the Framingham Heart Study. Hypertension. 1991 Jan;17(1):22-7. doi: 10.1161/01.hyp.17.1.22.
PubMed 1986979Julius S, Jamerson K, Mejia A, Krause L, Schork N, Jones K. The association of borderline hypertension with target organ changes and higher coronary risk. Tecumseh Blood Pressure study. JAMA. 1990 Jul 18;264(3):354-8.
PubMed 2362331Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.
PubMed 12748199The Foundations of Osteopathic Medicine, 3rd edition. Lippincott, Williams, and Wilkins. 2010. ISBN 0781766710
Fitzgerald M, Stiles, E: Osteopathic Hospitals' solution to DRGs may be OMT. The DO Nov. 1984: 97-101
Rogers JT, Rogers JC. The role of osteopathic manipulative therapy in the treatment of coronary heart disease. J Am Osteopath Assoc. 1976 Sep;76(1):21-31. No abstract available.
PubMed 1048963Lown B, Verrier RL, Rabinowitz SH. Neural and psychologic mechanisms and the problem of sudden cardiac death. Am J Cardiol. 1977 May 26;39(6):890-902. doi: 10.1016/s0002-9149(77)80044-1.
PubMed 860697Cox JM, Gorbis S, Dick LM, Rogers JC, Rogers FJ. Palpable musculoskeletal findings in coronary artery disease: results of a double-blind study. J Am Osteopath Assoc. 1983 Jul;82(11):832-6. No abstract available.
PubMed 6885531
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utilization of Osteopathic Manipulation (OMT) as an Adjunct Therapy in the Treatment of Hypertension
- ClinicalTrials.gov ID
- NCT02605551
- Acronym / sponsor ID
- HOT / LCH-2-022015
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study Period Ended / Not Completed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Larkin Community HospitalUniversity, hospital or other
- Collaborators
- Miami Beach Community Health Center
- Study start
- 1 Apr 2015 (estimated)
- Primary completion
- 30 Mar 2016 (actual)
- Study completion
- 30 Mar 2016 (actual)
- First posted
- 16 Nov 2015 (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 goal of this study is to demonstrate the use of osteopathic manipulative therapy (OMT) in the effective management of hypertension. The investigators hypothesize that by addressing/correcting somatic dysfunctions with OMT, the sympathetic overdrive that could be the root cause of the elevation in blood pressure will be downregulated. If this is the case, then an effective therapy for hypertension could indeed be regular OMT treatment. This could also result in the avoidance of potentially harmful antihypertensive medications which comprise a majority of the current therapeutic strategy in the treatment of hypertension (along with lifestyle modification). A third implication of the results of this project could be a reduction in the progression of this disease. Under the current standard of care, a majority of hypertensive patients only experience a worsening of the disease over time under the current therapeutic guidelines.
Detailed description
Approximately 60% of American adult population has prehypertension or hypertension. Subgroups such as African Americans, elderly, low-socioeconomic-status, and the overweight population, are disproportionately affected. Larkin Community Hospital (LCH) and its affiliated sites provide a great number of patients in these particular subgroups and this represents an ideal institution to study this tremendous health issue. Hypertension is a progressive disease and it has been shown·that, later in life, patients with borderline hypertension will progress at a much higher rate to Stage 1 or 2 hypertension as compared with normotensive population. The Framingham study has been demonstrated after 26 years of follow up, that 71% of patients with high-normal blood pressure (systolic, 130-139 mm Hg; diastolic, 85-89) developed clinical hypertension later in life. The Tecumseh blood pressure study has shown that subjects aged between 20 and 40 years old with borderline hypertension (average BP 130.7/93.8) have had significantly higher childhood (average age 6 years) BP levels compared with normotensive ones, further illustrating the propensity of this disease to progress. Also, the bell-shaped curve of blood pressure in the general population shows that the largest group of people will have blood pressures in the prehypertensive range, showing what a large proportion of the population would be affected by advances in the management of this disease.
Osteopathic manipulative therapy (OMT) is a therapeutic modality utilized by osteopathic physicians to address somatic dysfunctions in the musculoskeletal system. Somatic dysfunctions are abnormalities in musculoskeletal tissue texture and intervertebral joint dysfunction. Close associations between spinal vertebrae and the autonomic nervous system via the sympathetic trunk and ganglia are believed to be one of the mechanisms by which musculoskeletal system changes can affect other organs (somatovisceral reflex). Indeed, osteopathic philosophy posits that OMT has a distinct effect beyond the musculoskeletal system. Additionally, the autonomic and lymphatic systems and their effects upon the function of the cardiovascular system have been extensively studied. OMT has been shown by Stiles to significantly decrease both mortality and morbidity of patients with cardiovascular dysfunctions. Rogers et al. have also reported that OMT has been demonstrated to be of significant value in some patients with coronary insufficiency.
The bulk of the sympathetic nervous system lies adjacent to the thoracic spine as well as the superior lumbar spine. Particularly, the sympathetic innervation of the heart has its origins in cord segments T1-T6, with synapses occurring between pre-and post-ganglionic fibers in the upper thoracic and/or cervical ganglia. As previously discussed, alterations in the spinal mechanics and the presence of somatic dysfunctions in these regions of the spine have been theorized to alter the function of the autonomic nervous system originating from these regions. Specific cardiovascular effects of these dysfunctions are increased heart rate, increased contractility, increased cardiac work-load, and increased total peripheral resistance. To provide further evidence of the link between the musculoskeletal system and the cardiovascular system, it was demonstrated that patients with Travell triggerpoints in the right pectoralis muscle may be prone to periods of supraventricular tachyarrhythmias. When these trigger points are the etiologies of the arrhythmias, the arrhythmia disappears when the trigger point is effectively treated.
The goal of this study is to demonstrate the use of OMT in the effective management of hypertension. The investigators hypothesize that by addressing/correcting somatic dysfunctions with OMT, it will downregulate the sympathetic overdrive that could be the root cause of the elevation in blood pressure. If this is the case, then an effective therapy for hypertension could indeed be regular OMT treatment. This could also result in the avoidance of potentially harmful antihypertensive medications which comprise a majority of the current therapeutic strategy in the treatment of hypertension (along with lifestyle modification). A third implication of the results of this project could be a reduction in the progression of this disease. As discussed above, a majority of hypertensive patients only experience a worsening of the disease over time under the current therapeutic guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMT Group | Active comparator | Procedure: Osteopathic Manipulative Therapy, Behavioral: Lifestyle ModificationDuring the initial visit, the subject will have his BP recorded manually by the osteopathic physician in a standardized fashion. The subject will then undergo the OMT protocol and have his BP recorded again immediately afterwards. This will represent the conclusion of the initial visit. There will be 2 subsequent visits about 2-3 weeks apart that will be identical to this visit. Following the third visit, the next follow-up will be 2 months afterwards. However, the patient will only have his BP checked, and will not undergo an OMT treatment. The final visit will be another 2 months afterwards and will also be a simple BP check with no OMT treatment. The principles of lifestyle modification (diet/exercise/weight loss) will also be discussed at each visit. |
| Control Group | Placebo comparator | Behavioral: Lifestyle ModificationPatients in this arm will only receive lifestyle modification recommendations at each visit, along with a BP check. No antihypertensive medication changes will be made unless indicated by the guidelines. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Blood pressure meeting the criteria for pre-hypertension (130-139/85-89) or stage 1 hypertension (140-159/90-99) at two different instances
- Otherwise healthy adult patients consenting to study participation
Key exclusion criteria (6 listed)
- Presence of co-morbid renal or liver disease
- medication regimen of more than one anti-hypertensive medication
- Presence of pre-existing heart disease, CAD (coronary artery disease), severe stenotic valvular disease, CHF (congestive heart failure), cardiomyopathy
- Presence of condition that would make application of OMT protocol impossible
- Pregnancy
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 |
|---|---|---|
| Osteopathic Manipulative TherapyAlso: OMT, OMM, NMM, Osteopathic Manipulation TreatmentAll OMT techniques will be performed by osteopathic physicians who will have received training specific to this protocol prior to study initiation. All used techniques will be slow moving and gentle to augment rest and relaxation, promote autonomic balance, and release fascial contractures. The techniques that will be used in this protocol are: 1. OM Occipitomastoid release technique 2. Sub-Occipital Release Technique 3. Rib Raising Technique 4. Rotatory stimulation of posterior Chapman's Reflexes 5. Lymphatic Pumps and Effleurage: (Pedal Pump of Dalrymple) | Procedure or surgery | OMT Group |
| Lifestyle ModificationPatients will be counseled on healthy behaviors such as regular exercise, weight loss, and a healthy diet | Behavioural | Control Group, OMT Group |
Primary outcome
Blood Pressure
Time frame: 14 weeks
Participants will have an initial BP measurement, followed by measurements at 2, 4 and 6 weeks (both before and after OMT treatment performed at those visits). Then, they will have a simple BP check at 10 weeks and finally at 14 weeks. The goal of these measurements is to ascertain whether or not there is a change of baseline systolic/diastolic BP with serial OMT treatments
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- BackgroundDaiber WF: Disorders of the Kidneys in Hoag JM (ed) Osteopathic Medicine. New York, McGraw-Hill, 1969, Ch 39, PP644-5
- Background: PubMed 15505126Wang Y, Wang QJ. The prevalence of prehypertension and hypertension among US adults according to the new joint national committee guidelines: new challenges of the old problem. Arch Intern Med. 2004 Oct 25;164(19):2126-34. doi: 10.1001/archinte.164.19.2126.
- Background: PubMed 4933751Julius S, Schork MA. Borderline hypertension--a critical review. J Chronic Dis. 1971 Mar;23(10):723-54. doi: 10.1016/0021-9681(71)90005-1. No abstract available.
- Background: PubMed 1986979Leitschuh M, Cupples LA, Kannel W, Gagnon D, Chobanian A. High-normal blood pressure progression to hypertension in the Framingham Heart Study. Hypertension. 1991 Jan;17(1):22-7. doi: 10.1161/01.hyp.17.1.22.
- Background: PubMed 2362331Julius S, Jamerson K, Mejia A, Krause L, Schork N, Jones K. The association of borderline hypertension with target organ changes and higher coronary risk. Tecumseh Blood Pressure study. JAMA. 1990 Jul 18;264(3):354-8.
- Background: PubMed 12748199Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.
- BackgroundThe Foundations of Osteopathic Medicine, 3rd edition. Lippincott, Williams, and Wilkins. 2010. ISBN 0781766710
- BackgroundFitzgerald M, Stiles, E: Osteopathic Hospitals' solution to DRGs may be OMT. The DO Nov. 1984: 97-101
- Background: PubMed 1048963Rogers JT, Rogers JC. The role of osteopathic manipulative therapy in the treatment of coronary heart disease. J Am Osteopath Assoc. 1976 Sep;76(1):21-31. No abstract available.
- Background: PubMed 860697Lown B, Verrier RL, Rabinowitz SH. Neural and psychologic mechanisms and the problem of sudden cardiac death. Am J Cardiol. 1977 May 26;39(6):890-902. doi: 10.1016/s0002-9149(77)80044-1.
- Background: PubMed 6885531Cox JM, Gorbis S, Dick LM, Rogers JC, Rogers FJ. Palpable musculoskeletal findings in coronary artery disease: results of a double-blind study. J Am Osteopath Assoc. 1983 Jul;82(11):832-6. No abstract available.
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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.
Rohit S Mehra, DO, MPH, MS principal investigator
Larkin Community Hospital
David Stuckey, DO study director
Larkin Community Hospital
Scott E Spagnolo-Hye, DO, MS study chair
Larkin Community Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Therapy and Lifestyle Modification in people with Prehypertension and Hypertension, run by Larkin Community Hospital.
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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 16 Oct 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Blood Pressure (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02605551, which also lists 11 linked publications.
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 16 Oct 2023.