High Blood PressureNCT04479384
The Immediate Effect of an Osteopathic Manual Treatment on Blood Pressure in Adults With Hypertension - a Pilot Study.
A study testing Manual therapy - osteopathic techniques in people with High Blood Pressure, run by International Academy of Osteopathy at 1 site in Denmark.
Trial summary
The aim of this study was to determine if 4 manual osteopathic treatment techniques; Spinal manipulation, stretch intrathoracic fascia, sternum recoil and cranial base release has an immediate effect on blood pressure (BP) in hypertensive adults. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- Manual therapy - osteopathic techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2019to 1 May 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults 18-60 years old.
- Primary hypertension.
- Hypertension not more than grade 2, defined as: Systolic BP from 135-174 mmHg and diastolic BP from 85-104 mmHg.
Who cannot join
- Hypertension grade 3, defined as: Systolic BP from >175 mmHg and diastolic BP >105 mmHg, due to high risk of developing stroke, apoplexy and myocardial infarct.
- Positive hepato-jugular-reflux test, as a safety-test, to test pathological conditions of the heart.
- History of liver, kidney or known heart diseases, diagnosed by family physician as these conditions can contribute to secondary hypertension.
- Presence of contraindications for manual treatment, such as (but not limited to); infections, neurological symptoms, inflammation, haemophilia, ankylosis, prosthesis, pregnancy, cancer, osteoporosis, trauma and the use of blood-thinning medicines or corticosteroids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Immediate Effect of an Osteopathic Manual Treatment on Blood Pressure in Adults With Hypertension - a Pilot Study
The aim of this study was to determine if 4 manual osteopathic treatment techniques; Spinal manipulation, stretch intrathoracic fascia, sternum recoil and cranial base release has an immediate effect on blood pressure (BP) in hypertensive adults.
Read the detailed description
30 hypertensive adults (age=50.76±8.66 years, height= 1.75±0.082 m, weight=89.5±19.08 kg), were randomly assigned into one of two equally sized groups; a non- intervention and an intervention group in which patients received 4 manual techniques. Outcome measures included systolic- and diastolic BP pre-treatment and post-treatment 1-,5-, and 10-minutes. Two-way mixed ANOVA was used for statistical analysis.
- Conditions
- High Blood Pressure
- Being tested
- Manual therapy - osteopathic techniques
- Keywords
- Hypertension, Manual techniques, Blood Pressure, Osteopathy, Treatment
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapy - osteopathic techniquesOther
- HVLAT if any somatic dysfunction in T1-T5
- Stretch intrathoracic fascia x 3
- Recoil sternum x 3
- Cranial base release, 4 phases
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Thoracic manipulation T1-T5 if somatic dysfunction. Intrathoracic fascia stretch x 3. Recoil sternum x 3. Cranial base release - 4 steps. Receives: Other: Manual therapy - osteopathic techniques |
| Control group | No intervention | Supine position 10 minutes on the bench. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and diastolic blood pressure baseline
Systolic blood pressure and diastolic blood pressure
Measured: Baseline
Systolic and diastolic blood pressure post 1-minute
Systolic blood pressure and diastolic blood pressure
Measured: Post 1-minute
Systolic and diastolic blood pressure post 5-minute
Systolic blood pressure and diastolic blood pressure
Measured: Post 5-minute
Systolic and diastolic blood pressure post 10-minute
Systolic blood pressure and diastolic blood pressure
Measured: Post 10-minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start1 Sep 2019
- Primary completion30 Jan 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood PressureStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Academy of Osteopathy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mette Pedersen, BSc, Principal investigator, International Academy of Osteopathy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479384
- Sponsor's protocol ID
- 201910 EN PEDERSEN M PROTOCOL
- Status last verified
- Jul 2020
- First submitted
- 16 Jul 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effect of an Osteopathic Manual Treatment on Blood Pressure in Adults With Hypertension - a Pilot Study
- ClinicalTrials.gov ID
- NCT04479384
- Acronym / sponsor ID
- 201910 EN PEDERSEN M PROTOCOL
- Conditions
- High Blood Pressure
- Keywords
- Hypertension, Manual techniques, Blood Pressure, Osteopathy, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- International Academy of OsteopathyUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 21 Jul 2020 (actual)
- 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 aim of this study was to determine if 4 manual osteopathic treatment techniques; Spinal manipulation, stretch intrathoracic fascia, sternum recoil and cranial base release has an immediate effect on blood pressure (BP) in hypertensive adults.
Detailed description
30 hypertensive adults (age=50.76±8.66 years, height= 1.75±0.082 m, weight=89.5±19.08 kg), were randomly assigned into one of two equally sized groups; a non- intervention and an intervention group in which patients received 4 manual techniques. Outcome measures included systolic- and diastolic BP pre-treatment and post-treatment 1-,5-, and 10-minutes. Two-way mixed ANOVA was used for statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Manual therapy - osteopathic techniquesThoracic manipulation T1-T5 if somatic dysfunction. Intrathoracic fascia stretch x 3. Recoil sternum x 3. Cranial base release - 4 steps. |
| Control group | No intervention | –Supine position 10 minutes on the bench. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults 18-60 years old.
- Primary hypertension.
- Hypertension not more than grade 2, defined as: Systolic BP from 135-174 mmHg and diastolic BP from 85-104 mmHg.
Key exclusion criteria (4 listed)
- Hypertension grade 3, defined as: Systolic BP from >175 mmHg and diastolic BP >105 mmHg, due to high risk of developing stroke, apoplexy and myocardial infarct.
- Positive hepato-jugular-reflux test, as a safety-test, to test pathological conditions of the heart.
- History of liver, kidney or known heart diseases, diagnosed by family physician as these conditions can contribute to secondary hypertension.
- Presence of contraindications for manual treatment, such as (but not limited to); infections, neurological symptoms, inflammation, haemophilia, ankylosis, prosthesis, pregnancy, cancer, osteoporosis, trauma and the use of blood-thinning medicines or corticosteroids.
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 |
|---|---|---|
| Manual therapy - osteopathic techniques* HVLAT if any somatic dysfunction in T1-T5 * Stretch intrathoracic fascia x 3 * Recoil sternum x 3 * Cranial base release, 4 phases | Other | Intervention group |
Primary outcome
Systolic and diastolic blood pressure baseline
Time frame: Baseline
Systolic blood pressure and diastolic blood pressure
Systolic and diastolic blood pressure post 1-minute
Time frame: Post 1-minute
Systolic blood pressure and diastolic blood pressure
Systolic and diastolic blood pressure post 5-minute
Time frame: Post 5-minute
Systolic blood pressure and diastolic blood pressure
Systolic and diastolic blood pressure post 10-minute
Time frame: Post 10-minute
Systolic blood pressure and diastolic blood pressure
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 21 Jul 2020.
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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.
Mette Pedersen, BSc principal investigator
International Academy of Osteopathy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy - osteopathic techniques in people with High Blood Pressure, run by International Academy of Osteopathy at 1 site in Denmark.
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 3 inclusion and 4 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 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Systolic and diastolic blood pressure baseline (time frame: Baseline). The study lists 4 primary outcomes in all. 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 21 Jul 2020.