An Early Phase 1 interventional study of Active osteopathic treatment (OMT+PR): Active Comparator and sham osteopathic treatment (SOT+PR) in Chronic Obstructive Pulmonary Disease, sponsored by Fondazione Salvatore Maugeri. Completed at 1 site in Italy. Open to participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-10-24.
Sponsored by Fondazione Salvatore Maugeri · Early Phase 1, Interventional, and Supportive care
The purpose of this trial is to verify if an osteopathic treatment added to usual pulmonary rehabilitation trial is able to improve the walking ability of COPD patients and if there is any influence on lung functionality.
The investigators decided to perform an osteopathic manipulative treatment (OMT) in a population of COPD patients. OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner to improve physiologic function and/or support homeostasis that has been altered by somatic dysfunction. Concerning the respiratory system, osteopathy considers a model that describes the interdependent functions among five body components as follows: 1: the inherent motility of the brain and spinal cord; 2: fluctuation of the cerebrospinal fluid; 3: mobility of the intracranial and intraspinal membranes; 4: articular mobility of the cranial bones; 5: the involuntary mobility of the sacrum between the ilia. This model is the so called primary respiratory mechanism.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 20 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
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Exclusion Criteria:
The examination was performed by osteopathic practitioners with emphasis on the neuromusculoskeletal system including palpatory diagnosis for somatic dysfunction and viscerosomatic change, in the context of total patient care. The examination was concerned with range of motion of all parts of the body, performed with the patient in multiple positions to provide static and dynamic evaluation.
Other: Active osteopathic treatment (OMT+PR): Active Comparator
Sham osteopathic treatment (manipulation)
Other: sham osteopathic treatment (SOT+PR)
The treatment was done once a week for 4 weeks and lasted 30 minutes.The examination was done according to the following scheme: anamnesis; physical examination (evaluation of the posture, palpation, tests for passive and active motion of areas linked to altered respiratory function); cranic-sacral evaluation (by means of a palpation of the cranic-sacral mechanism).
Also known as: OMT+PR
Only soft manipulation was performed
Also known as: SOT+PR
Walking Ability
6 minutes walking test (6MWT)
Time frame: 4 weeks
Lung Function Test
residual volume (RV)
Time frame: 4 weeks
| Milestone | Active Osteopathic Treatment | Sham Osteopathic Treatment (Manipulation) |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
6 minutes walking test (6MWT)
| meters | Active Osteopathic Treatment | Sham Osteopathic Treatment (Manipulation) |
|---|---|---|
| Walking Ability | 369.5 ± 80 | 304.7 ± 96.6 |
residual volume (RV)
| liters | Active Osteopathic Treatment | Sham Osteopathic Treatment (Manipulation) |
|---|---|---|
| Lung Function Test | 3.09 ± 1.7 | 4.23 ± 1.4 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Osteopathic Treatment | — | — | — |
| Sham Osteopathic Treatment (Manipulation) | — | — | — |
| Age, Categorical(Participants) | Active Osteopathic Treatment | Sham Osteopathic Treatment (Manipulation) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 4 | 12 |
| >=65 years | 2 | 6 | 8 |
| Age Continuous(years) | Active Osteopathic Treatment | Sham Osteopathic Treatment (Manipulation) | Total |
|---|---|---|---|
| Mean | 64.2 ± 5.5 | 63.5 ± 4.7 | 63.8 ± 5.1 |
| Sex: Female, Male(Participants) | Active Osteopathic Treatment | Sham Osteopathic Treatment (Manipulation) | Total |
|---|---|---|---|
| Female | 2 | 3 | 5 |
| Male | 8 | 7 | 15 |
| Region of Enrollment(participants) | Active Osteopathic Treatment | Sham Osteopathic Treatment (Manipulation) | Total |
|---|---|---|---|
| Italy | 10 | 10 | 20 |
This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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Fondazione Salvatore Maugeri