AsthmaOMTNCT01853189
Effectiveness of Osteopathic Manipulative Treatment in Pediatric Asthma
A study of Asthma, run by European Institute for Evidence Based Osteopathic Medicine at 1 site in Italy.
Trial summary
Asthma is a highly prevalent chronic disease in children. Complementary and Alternative Medicine research on asthma showed a potential effect on pediatric patients. Studies looking at the effect of Osteopathic Manipulative Treatment seems to reveal positive results. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Asthma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2014to Dec 2015
- 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 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with asthma age between 5 and 14
Who cannot join
- associated co-morbities surgical patients
Trial locations and contacts
1 site in 1 country.
Italy1 site
Santo Spirito Hospital
Pescara, Abruzzo, 65100
Francesco Cerritelli, MS,DO, +393394332801, francesco.cerritelli@ebom.it
About this study
Asthma is a highly prevalent chronic disease in children. Complementary and Alternative Medicine research on asthma showed a potential effect on pediatric patients.
Studies looking at the effect of Osteopathic Manipulative Treatment seems to reveal positive results.
The aim of study is to further explore the role of OMT on asthma in a pediatric population.
- Conditions
- Asthma
- Being tested
- OMT + Usual Care, Usual Care
- Keywords
- pediatrics, asthma, osteopathic manipulative treatment
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMT + Usual CareOther
patients from this group received 6 sessions of OMT
Usual CareOther
patients from control group received standard care + osteopathic evaluation only, according to the same schedule of the study group
| Study group | Role | What they receive |
|---|---|---|
| OMT + Usual Care | Other | Not described Receives: Other: OMT + Usual Care |
| Usual Care | Other | Not described Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Forced expiratory volume in the 1st second (FEV1) before and after OMT
Measured: Participants will be assessed at entry, after 3 and 6 months.
Secondary outcomes (5)
Difference in fractional exhaled nitric oxide (FeNO) before and after OMT
Measured: Participants will be assessed at entry, after 3 and 6 months.
Difference in percentage of hemoglobin saturation before and after OMT
Measured: Participants will be assessed at entry, after 3 and 6 months.
Difference in Pediatric Asthma Quality of Life Questionnaire (PAQOL) before and after OMT
Measured: Participants will be assessed at entry, after 3 and 6 months.
Differences in the number, type and quality of somatic dysfunctions
Measured: Participants will be assessed at entry, after 3 and 6 months
Difference in peak expiratory flow (PEF) before and after OMT
Measured: Participants will be assessed at entry, after 3 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startNov 2014
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute for Evidence Based Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853189
- Sponsor's protocol ID
- OAsPed-1
- Acronym
- OMT
- Status last verified
- Apr 2014
- First submitted
- 10 May 2013
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Osteopathic Manipulative Treatment in Pediatric Asthma
- ClinicalTrials.gov ID
- NCT01853189
- Acronym / sponsor ID
- OMT / OAsPed-1
- Conditions
- Asthma
- Keywords
- pediatrics, asthma, osteopathic manipulative treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- European Institute for Evidence Based Osteopathic MedicineUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 14 May 2013 (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.
Asthma is a highly prevalent chronic disease in children. Complementary and Alternative Medicine research on asthma showed a potential effect on pediatric patients.
Studies looking at the effect of Osteopathic Manipulative Treatment seems to reveal positive results.
The aim of study is to further explore the role of OMT on asthma in a pediatric population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMT + Usual Care | Other | Other: OMT + Usual Care |
| Usual Care | Other | Other: Usual Care |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children with asthma age between 5 and 14
Key exclusion criteria (1 listed)
- associated co-morbities surgical patients
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 |
|---|---|---|
| OMT + Usual Carepatients from this group received 6 sessions of OMT | Other | OMT + Usual Care |
| Usual Carepatients from control group received standard care + osteopathic evaluation only, according to the same schedule of the study group | Other | Usual Care |
Primary outcome
Difference in Forced expiratory volume in the 1st second (FEV1) before and after OMT
Time frame: Participants will be assessed at entry, after 3 and 6 months.
5 secondary outcomes
Difference in fractional exhaled nitric oxide (FeNO) before and after OMT
Time frame: Participants will be assessed at entry, after 3 and 6 months.
Difference in percentage of hemoglobin saturation before and after OMT
Time frame: Participants will be assessed at entry, after 3 and 6 months.
Difference in Pediatric Asthma Quality of Life Questionnaire (PAQOL) before and after OMT
Time frame: Participants will be assessed at entry, after 3 and 6 months.
Differences in the number, type and quality of somatic dysfunctions
Time frame: Participants will be assessed at entry, after 3 and 6 months
Difference in peak expiratory flow (PEF) before and after OMT
Time frame: Participants will be assessed at entry, after 3 and 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Asthma, run by European Institute for Evidence Based Osteopathic Medicine at 1 site in Italy.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Apr 2014. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Cerritelli, MS, DO (+393394332801, francesco.cerritelli@ebom.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Forced expiratory volume in the 1st second (FEV1) before and after OMT (time frame: Participants will be assessed at entry, after 3 and 6 months.). 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 25 Apr 2014.