Francesca Galiano
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08/08/2022 - Last update 30/12/2022

David A Swender, Gina Thompson, Kristen Schneider, Karen McCoy, Alpa Patel | Year 2014

Osteopathic manipulative treatment for inpatients with pulmonary exacerbations of cystic fibrosis

Pathology:

Cystic fibrosis

Type of study:

Randomized controlled trial

Date of publication of the study’:

2014/Jun/01

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Purpose of the study

  • Objective: to evaluate the usefulness of OMT in adults inpatients with cystic fibrosis in case of pulmonary exacerbation
  • Measured outcomes:
    • Primary: change in the pulmonary function measured by spirometry of forced expiratory volume in 1 second percentage (FEV1%)
    • Secondary: change in other spirometry’s measures: weight, temperature, heart rate, pulse oximetry, blood pressure, respiratory rate, perception of breath, anxiety and pain

Participants

  • Number: 33 people (14 female and 19 male)
  • Criteria of inclusion: age 18-50 years, hospitalized with primary diagnosis of pulmonary exacerbation of cystic fibrosis, FEV1% equal to or greater than 30% of the predicted value determined through spirometry performed within 24 hours of admission, symptoms of exacerbation.
  • Criteria of exclusion: substantial hemoptysis (> 5ml) upon admission, diagnosis of allergic bronchopulmonary aspergillosis, severe pulmonary disease (FEV1% less than 30% of the predicted value), oxygen requirement 24 hours after admission, hospitalization in pediatric intensive care unit, intubation during the hospitalization, severe spinal injuries, musculoskeletal malformations or injuries.
  • Groups of study: two groups obtained by randomization
    • Group 1: standard of care with the addiction of OMT, 16 people (10 female and 6 male, mean age 26.6 years)
    • Group 2: standard of care with the addiction of sham treatment, 17 people (4 female and 13 male, mean age 22.5 years)

Interventions and evaluations

  • Evaluation through spirometry of the pulmonary function at the beginning and at the end of the study
  • Evaluation through questionnaire of the perception of breathing, anxiety and pain at the beginning and at the end of the study
  • 1 OMT session (15 minutes) or 1 sham treatment session (15 minutes) per day, for a minimum of 4 days and a maximum of 7 days, depending on length of stay
  • Standard of care: received by all patients, included antibiotics, pulmonary physiotherapy, massage, recreational therapy
  • OMT: five standardized techniques, namely rib raising, abdominal diaphragm release, thoracic inlet myofascial release, thoracic lymphatic pump techniques, suboccipital decompression
  • Sham treatment: five standardized techniques modeled on the basis of the OMT, but with some differences, ie, avoiding prolonged contact with an area, using a minimum pressure and directing it towards the bed or towards “non-osteopathic” areas (eg, not to the column, but to nearby tissues), avoiding focal areas of pressure by using the entire palm of the hand
  • OMT and sham treatment performed by three osteopathic doctors, each of them followed a 15-minute session, supervised by a specialized osteopathic doctor, so as to perform the techniques in the same way

Results

  • Primary outcomes: both groups showed the same improvement of FEV1%, with the result that between the two treatments no statistically significant difference emerged.
  • Secondary outcomes: the changes in vital parameters and weight between before and after treatment were not different between the two intervention groups, although the OMT group showed a greater decrease in temperature. Other pulmonary function parameters measured by spirometry (e.g. forced vital capacity or FVC, FEV1/FVC and forced expiratory flow during expiration from 25% to 75% of FVC or FEF 25-75%) increased in both groups (FEV1/FVC and FEF 25-75% more for OMT, while FVC more for sham treatment) but without significant differences from a statistical point of view.

As for the perception of the quality of their breathing, 15 out of 16 patients in the OMT group reported better breathing than usual, while only 8 out of 16 (1 patient did not complete the questionnaire) in the sham group reported better breathing than usual. Regarding anxiety and pain, both groups showed a tendency to improve. At the level of adverse effects, only 1 patient reported slight nausea after OMT.

Discussion

Between the two groups no statistically significant differences were found: both showed a general improvement in all parameters, objective (pulmonary function measured by spirometry and vital parameters) and subjective (breathing quality, anxiety and pain).

The OMT has perhaps induced a better perception of the patients’ own breathing, probably thanks to the ability of the OMT to act at the level of the interoceptive pathways linked to body perception.
Since the standard cures for pulmonary exacerbation of cystic fibrosis are many and varied, these same cures may have concealed the effects of OMT. As possible backing to this hypothesis, the authors refer to the improved perception of the quality of breathing reported by patients who received OMT.

Other studies are needed to assess both the effectiveness of OMT in other stages of cystic fibrosis (eg, not during a pulmonary exacerbation hospitalization), to assess the ability of the OMT to manage the disease and prevent worsening, or studies where the OMT would be the only manual treatment applied, perhaps compared with standard physiotherapy. Although, there is the possibility, according to the authors, that in case of chronic and progressive pulmonary diseases the OMT may be ineffective.

The review of Osteopedia

By Marco Chiera

Strengths: first study carried out on OMT and cystic fibrosis; the standardization of techniques allows the study to be easily replicated; use of both quantitative and qualitative measurements.

Limits: the use of physiotherapy or massage in standard care may have “invalidated” the OMT, preventing the authors from detecting its specific effects; small sample and, therefore, potentially under-powered study and not able to highlight effects of OMT; if the standardization of the techniques allows the replication of the study, however, the OMT is by its nature individualized on the individual needs of the patient.

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