Francesca Galiano
|
08/08/2022 - Last update 30/12/2022
LaQuita M Jones, Christopher Regan, Kimberly Wolf, Jenifer Bryant, Alexander Rakowsky, Melissa Pe, Dane A Snyder | Year 2021
Effect of osteopathic manipulative treatment on pulmonary function testing in children with asthma
Pathology:
Asthma
Type of study:
Randomized controlled trial
Date of publication of the study’:
2021/May/07
Purpose of the study
- Objective: to evaluate the efficacy of OMT in children with asthma
- Measured outcomes:
- Primary: pulmonary function testing (PFT) in particular the following parameters: forced vital capacity (FVC), forced expiration volume in 1 second (FEV1), FEV1/FVC, forced expiratory flow during expiration from 25% to 75% of the FVC (FEF 25-75%)
Participants
- Number: 58 children (27 female and 31 male)
- Criteria of inclusion: children between the ages of 7-18 years, diagnosed with asthma, who were following standard care at a primary care asthma clinic and who had performed a spirometry to assess basic respiratory function.
- Criteria of exclusion: clinical indications for pre- and post-bronchodilator spirometry on the day of their visit; use of albuterol over the last 8 hours; use of oral steroids in the previous 2 weeks; diagnosis of asthma exacerbation in the previous 4 weeks.
- Study groups: two groups obtained by randomization
- Group 1: standard care with the addition of OMT, 31 children (12 female and 19 male, a mean age of 11 years)
- 18 children with persistent asthma and 13 with intermittent asthma
- Group 2: standard of care, 27 children (15 female and 12 male, a mean age of 11 years)
- 18 children with persistent asthma and 9 with intermittent asthma
- Group 1: standard care with the addition of OMT, 31 children (12 female and 19 male, a mean age of 11 years)
Interventions and evaluations
- Before treatment, spirometry to assess basic pulmonary function
- At the end of the examination, spirometry to assess post-treatment pulmonary function
- OMT: asthma standard of care with the addition of rib raising and suboccipital release techniques
- Standard of care: medical evaluation and education by a multidisciplinary team
- OMT performed by osteopathic pediatric residents specifically trained for this study (pre-training), so that the techniques used would be performed in the same way by all of them
- Spirometry carried out by an experienced respiratory therapist in pediatrics blind to the allocation of children
Results
- Primary outcomes: Compared to standard care alone, the addition of OMT reported an improvement in respiratory indices. Moreover, while in the OMT group the values of FVC, FEV1 and FEF 25-75% have all increased – of the 2.4%, 2.4% and 4.4% respectively – in the group with only standard care the FEF 25-75% and the FEV1/FVC ratio have decreased, as well as FVC and FEV1 in children with intermittent asthma.
However, statistical significance has not been reached.
Discussion
In addition to standard of care, OMT has been found able to improve respiratory function. Although the statistical significance was not reached, two results – FEF 25-75% and FEV1 – came very close (p-value of 0.05 and 0.06, respectively) and perhaps could have been significant with a larger sample of children.
However, the increases in these parameters are far from those considered clinically significant (12% increase for FVC, FEV1, FEV1/FEC and 20% for FEF 25-75%). The reason for this “lack of results” may lie in the recruitment of children with stable asthma, as well as in the fact that the study examined only one intervention, among other things a very standardized one. Consequently, far from the reality where the OMT is normally a personalized treatment based on the patient’s clinical picture.
In support of the results obtained, other studies in the past had shown the potential usefulness of OMT in improving respiratory function in case of asthma, but also of pneumonia and cystic fibrosis.
Therefore, it is necessary to deepen these results on a larger number of children, evaluating the effect of OMT over time and evaluating OMT in general and not only two techniques.
The review of Osteopedia
By Marco Chiera
Strengths: the study brings other evidence of how OMT can be an added value for asthma; the use of pulmonary function tests, the gold standard for assessing respiratory function and for assessing the severity and the control status of asthma; the study bodes well since the results were obtained after only one treatment, or better actually, after the execution of only two standard techniques.
Limits: despite previous studies (also by the same authors) on OMT and asthma or respiratory function from which an estimate of the effectiveness of the OMT could be derived, the calculation of the adequate sample size was not carried out before the study (here is a possible reason for the non-statistical significance of the results: not enough children were present).
It is not clear why certain tests were performed instead of others in the statistical analysis (eg, test t instead of ANOVA).
The study evaluated an immediate and not a long-term effect, thus preventing us from understanding the actual effectiveness of the OMT.
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