Asthma in ChildrenNCT04764877
Effect of Osteopathic Manipulation Therapy on Pulmonary Function Testing in Children With Asthma
A study testing Osteopathic Manipulative Medicine in people with Asthma in Children, run by Nationwide Children's Hospital.
Trial summary
Objective To evaluate change in same-day pulmonary function testing in pediatric patients receiving OMT compared to those receiving usual care. Methods For this study, we selected patients utilizing the following inclusion criteria: 1) ages 7-18 years, 2) a diagnosis of asthma, 3) patients receiving care at a primary… Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Osteopathic Manipulative Medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2015to 31 Dec 2019
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age as noted above
- Diagnosis of asthma
- Scheduled for routine asthma care at our clinic
- at least one prior PFT done prior to this visit
Who cannot join
- Clinical indication for pre- and post-bronchodilator spirometry on day of visit
- albuterol use w/in 8 hours of the visit
- oral steroid use in previous 2 weeks
- diagnosis of asthma exacerbation w/in prior 4 weeks
About this study
Objective To evaluate change in same-day pulmonary function testing in pediatric patients receiving OMT compared to those receiving usual care.
Methods For this study, we selected patients utilizing the following inclusion criteria: 1) ages 7-18 years, 2) a diagnosis of asthma, 3) patients receiving care at a primary care-based asthma clinic, and 4) those patients who had baseline spirometry. Selected patients were then randomized to either an OMT or a control group. We excluded patients who were experiencing an acute asthma exacerbation. Patients in the OMT group were treated with rib raising and suboccipital release, in addition to standard asthma care, while control group patients received standard care only. A second PFT was performed on both groups at the end of the visit. OMT was performed by multiple osteopathic pediatric residents who were specifically trained for the purposes of this study. Change in spirometry results (FVC, FEV1, FVC/FEV1, and FEF 25-75%) were then compared.
Read the detailed description
Objective To evaluate change in same-day pulmonary function testing in pediatric patients receiving OMT compared to those receiving usual care.
Methods For this study, we selected patients utilizing the following inclusion criteria: 1) ages 7-18 years, 2) a diagnosis of asthma, 3) patients receiving care at a primary care-based asthma clinic, and 4) those patients who had baseline spirometry. Selected patients were then randomized to either an OMT or a control group. We excluded patients who were experiencing an acute asthma exacerbation. Patients in the OMT group were treated with rib raising and suboccipital release, in addition to standard asthma care, while control group patients received standard care only. A second PFT was performed on both groups at the end of the visit. OMT was performed by multiple osteopathic pediatric residents who were specifically trained for the purposes of this study. Change in spirometry results (FVC, FEV1, FVC/FEV1, and FEF 25-75%) were then compared.
NOTE: The OMTs were done either by our OMM attending at that time (Dr. Wolf) or by residents trained by her for this study (Drs. Jones, Pe, Bryant and Regan,)
- Conditions
- Asthma in Children
- Being tested
- Osteopathic Manipulative Medicine
- Keywords
- OMM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative MedicineOther
Provided 15-20 minute long OMT session for patients in the OMT arm
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Standard teaching and physical exam for any patient that would be seen at our Hilltop Primary Care center asthma clinic. This included baseline PFTs. FOR THIS STUDY a second set of PFTs were obtained at the end of the visit |
| OMT arm | Experimental | As above BUT with the addition of standardized OMT focusing on lung functionality. OMT provided by either our OMM attending at that time (Dr Wolf) or residents trained by her for this study (Drs. Regan, Jones, Pe and Bryant) Receives: Other: Osteopathic Manipulative Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FEV1 on pre-therapy and post-therapy PFTs
FEV1 improvement
Measured: 2 hours
Change in FEF25-75 on pre-therapy and post-therapy PFTs
FEV25-75 improvement
Measured: 2 hours
Change in FVC on pre-therapy and post-therapy PFTs
FVC improvement
Measured: 2 hours
Change in FVC/FEV1 on pre-therapy and post-therapy PFTs
Improvement in ratio
Measured: 2 hours
Secondary outcomes (1)
Standardized survey to look for adverse effects from the OMT
Standard form asking about common AEs seen with OMT
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Feb 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies 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
- Sequential
- Model description
- Patients were randomized to either standard of care/teaching at our Hilltop Primary Care Center Asthma clinic OR to standard of care/teaching PLUS one time osteopathic manipulation focusing on improving lung expansion.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Rakowsky, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764877
- Sponsor's protocol ID
- IRB #14-000667
- Status last verified
- Feb 2021
- First submitted
- 21 Jan 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study is completed and pending publication in the Journal of Osteopathic Medicine (formerly JAOA) Once published we do plan to share data with those interested
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Osteopathic Manipulation Therapy on Pulmonary Function Testing in Children With Asthma
- ClinicalTrials.gov ID
- NCT04764877
- Acronym / sponsor ID
- IRB #14-000667
- Conditions
- Asthma in Children
- Keywords
- OMM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 21 Feb 2021 (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.
Objective To evaluate change in same-day pulmonary function testing in pediatric patients receiving OMT compared to those receiving usual care.
Methods For this study, we selected patients utilizing the following inclusion criteria: 1) ages 7-18 years, 2) a diagnosis of asthma, 3) patients receiving care at a primary care-based asthma clinic, and 4) those patients who had baseline spirometry. Selected patients were then randomized to either an OMT or a control group. We excluded patients who were experiencing an acute asthma exacerbation. Patients in the OMT group were treated with rib raising and suboccipital release, in addition to standard asthma care, while control group patients received standard care only. A second PFT was performed on both groups at the end of the visit. OMT was performed by multiple osteopathic pediatric residents who were specifically trained for the purposes of this study. Change in spirometry results (FVC, FEV1, FVC/FEV1, and FEF 25-75%) were then compared.
Detailed description
Objective To evaluate change in same-day pulmonary function testing in pediatric patients receiving OMT compared to those receiving usual care.
Methods For this study, we selected patients utilizing the following inclusion criteria: 1) ages 7-18 years, 2) a diagnosis of asthma, 3) patients receiving care at a primary care-based asthma clinic, and 4) those patients who had baseline spirometry. Selected patients were then randomized to either an OMT or a control group. We excluded patients who were experiencing an acute asthma exacerbation. Patients in the OMT group were treated with rib raising and suboccipital release, in addition to standard asthma care, while control group patients received standard care only. A second PFT was performed on both groups at the end of the visit. OMT was performed by multiple osteopathic pediatric residents who were specifically trained for the purposes of this study. Change in spirometry results (FVC, FEV1, FVC/FEV1, and FEF 25-75%) were then compared.
NOTE: The OMTs were done either by our OMM attending at that time (Dr. Wolf) or by residents trained by her for this study (Drs. Jones, Pe, Bryant and Regan,)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were randomized to either standard of care/teaching at our Hilltop Primary Care Center Asthma clinic OR to standard of care/teaching PLUS one time osteopathic manipulation focusing on improving lung expansion.
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Standard teaching and physical exam for any patient that would be seen at our Hilltop Primary Care center asthma clinic. This included baseline PFTs. FOR THIS STUDY a second set of PFTs were obtained at the end of the visit |
| OMT arm | Experimental | Other: Osteopathic Manipulative MedicineAs above BUT with the addition of standardized OMT focusing on lung functionality. OMT provided by either our OMM attending at that time (Dr Wolf) or residents trained by her for this study (Drs. Regan, Jones, Pe and Bryant) |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age as noted above
- Diagnosis of asthma
- Scheduled for routine asthma care at our clinic
- at least one prior PFT done prior to this visit
Key exclusion criteria (4 listed)
- Clinical indication for pre- and post-bronchodilator spirometry on day of visit
- albuterol use w/in 8 hours of the visit
- oral steroid use in previous 2 weeks
- diagnosis of asthma exacerbation w/in prior 4 weeks
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 MedicineProvided 15-20 minute long OMT session for patients in the OMT arm | Other | OMT arm |
Primary outcome
Change in FEV1 on pre-therapy and post-therapy PFTs
Time frame: 2 hours
FEV1 improvement
Change in FEF25-75 on pre-therapy and post-therapy PFTs
Time frame: 2 hours
FEV25-75 improvement
Change in FVC on pre-therapy and post-therapy PFTs
Time frame: 2 hours
FVC improvement
Change in FVC/FEV1 on pre-therapy and post-therapy PFTs
Time frame: 2 hours
Improvement in ratio
1 secondary outcome
Standardized survey to look for adverse effects from the OMT
Time frame: 2 hours
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 Feb 2021.
- Individual participant dataSharing planned: Yes. Study is completed and pending publication in the Journal of Osteopathic Medicine (formerly JAOA) Once published we do plan to share data with those interested
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Medicine in people with Asthma in Children, run by Nationwide Children's 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 4 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 Feb 2021. 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.
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?
Change in FEV1 on pre-therapy and post-therapy PFTs (time frame: 2 hours). 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 Feb 2021.