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Effects of Osteopathic Techniques on Residual Volume in Severe Chronic Obstructive Pulmonary Disease

Primary Purpose

COPD

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
osteopathic manual therapy
control group
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, residual volume, osteopathy, hyperinflation

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a clinical diagnosis of COPD in accordance with GOLD,
  • post-bronchodilator FEV1 < 50% of predicted value,
  • smoking history of ≥ 10 pack-years,
  • the ability to remain in supine position for at least 25 minutes.

Exclusion Criteria:

  • exacerbation in the past 6 weeks,

Sites / Locations

  • Departament of Internal Medicine, Pneumonology and Allergology, Warsaw Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

osteopathic manual therapy (OMT group)

control group (C group)

Arm Description

patients who will undergo manual osteopathic therapy.

patients who will undergo manual therapy not aimed to decrease hyperinflation.

Outcomes

Primary Outcome Measures

Lung function tests (mainly residual volume) before and after selected osteopathic techniques in patients with COPD (III, IV degree of airway obstruction according to GOLD).

Secondary Outcome Measures

Full Information

First Posted
April 19, 2016
Last Updated
April 28, 2016
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT02755363
Brief Title
Effects of Osteopathic Techniques on Residual Volume in Severe Chronic Obstructive Pulmonary Disease
Official Title
Evaluation of the Immediate Effects of Osteopathic Techniques on Plethysmographic Measurement of Residual Volume in Patients With Severe Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether the selected osteopathic techniques have a positive impact on the residual volume decrease in patients with chronic obstructive pulmonary disease with severe and very severe airflow limitation in comparison to the manual therapy not aimed to decrease hyperinflation (placebo).
Detailed Description
Chronic obstructive pulmonary disease (COPD) is characterized by progressive and not fully reversible airflow limitation in the bronchi. Hyperinflation is one of the most important pathophysiological mechanisms responsible for shortness of breath in COPD patients. Hyperinflation may be assessed in body pletysmography in which residual volume (RV) and total lung capacity (TLC) are measured. These parameters are considered to precisely reflect the degree of hyperinflation. In patients with COPD, an increased breathing frequency, e.g. during exercise or disease exacerbation, leads to dynamic hyperinflation which further increases shortness of breath. The treatment of COPD includes smoking cessation, drug therapy, home oxygen therapy and rehabilitation. The disease is chronic, progressive and ultimately leads to premature death, so every new therapeutic option is a point of interest. In the recent years, there have been a few reports on the positive effects of osteopathic techniques on pulmonary function tests in patients with COPD. Osteopathy is a new area of healthcare, in which manual techniques are used to assess neuro-musculoskeletal performance and to optimize its function. STUDY OBJECTIVE the assessment of the influence of selected osteopathic techniques on RV in patients with COPD (III, IV degree of airway obstruction according to Global Initiative for Chronic Obstructive Lung Disease - GOLD). MATERIAL The patients will be recruited from an outpatient clinic and randomly assigned to 2 groups: group of osteopathic manual therapy (OMT group) - 10 patients - who will undergo 25 minutes of manual osteopathic therapy; control group (C group)- 10 patients - who will undergo 25 minutes of manual therapy not aimed to decrease hyperinflation, as placebo. Then, after a period of two-three weeks patients will be crossed over between the groups. METHODS Spirometry to assess forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) and body pletysmography with the measurement of RV will be performed before and 10 minutes after the manual therapy session. Manual therapy directed at the normalization of the autonomic nervous system (inhibition of the sympathetic nervous system) and at the improvement of chest wall mobility will be applied. The techniques are painless for the patient. In both investigated groups, all the techniques will be applied in supine position, after daily inhaled medication intake. The techniques to be applied in the OMT group include: suboccipital decompression - it is based on the pressure of suboccipital muscles with fingers of the therapist at the base of the skull. deep cervical fascia release - the therapist will move the thumb on the neck of the patient from cranium in the caudal direction over sternocleidomastoid, scalene, trapezius muscles. thoracic lymphatic pump with activation is - the therapist manually supports the breathing rhythm of the patient by the compression and decompression of the sternum effecting in the sterno-costal joints relaxation and intensification of the lymph flow of in the lymphatic thoracic duct. The impact on the thoracic duct is carried out by the rhythmic pressure differences while breathing and supported with hands of the therapist. stretching the diaphragm - the technique relies on manual catch by 10, 11 and rib cartilage, which will be held in the inspiratory direction during exhalation of the patient. The therapist will decide when the subsequent techniques will be terminated basing on the improvement of the flexibility and mobility of the treated area evaluated by palpation. The techniques to be applied in the C group include: manual mobilization techniques of the slides in the shoulder joint toward the front, rear and bottom. manual techniques to increase range of motion in the shoulder joints using the patient's breathing manoeuvres.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
COPD, residual volume, osteopathy, hyperinflation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
osteopathic manual therapy (OMT group)
Arm Type
Active Comparator
Arm Description
patients who will undergo manual osteopathic therapy.
Arm Title
control group (C group)
Arm Type
Placebo Comparator
Arm Description
patients who will undergo manual therapy not aimed to decrease hyperinflation.
Intervention Type
Other
Intervention Name(s)
osteopathic manual therapy
Intervention Description
suboccipital decompression - atlanto-occipital joint relaxation technique. deep cervical fascia release - the technique aims to improve mobility of the first and second ribs during expiration and to relaxation of the vagus and phrenic nerve course area. thoracic lymphatic pump with activation is designed to reduce the tension of mediastinal structures, improve lymphatic flow, and thus reduce the breathing resistance. stretching the diaphragm in order to relax and reduce adhesion within the fascial system between the diaphragm and abdominal organs.
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
manual mobilization techniques of the slides in the shoulder joint toward the front, rear and bottom. manual techniques to increase range of motion in the shoulder joints using the patient's breathing manoeuvres.
Primary Outcome Measure Information:
Title
Lung function tests (mainly residual volume) before and after selected osteopathic techniques in patients with COPD (III, IV degree of airway obstruction according to GOLD).
Time Frame
40 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a clinical diagnosis of COPD in accordance with GOLD, post-bronchodilator FEV1 < 50% of predicted value, smoking history of ≥ 10 pack-years, the ability to remain in supine position for at least 25 minutes. Exclusion Criteria: exacerbation in the past 6 weeks,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katarzyna Górska, PhD, MD
Phone
+48501077180
Email
drkpgorska@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katarzyna Górska, PhD, MD
Organizational Affiliation
WMU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departament of Internal Medicine, Pneumonology and Allergology, Warsaw Medical University
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katarzyna Górska, PhD
Phone
+48501077180
Email
drkpgorska@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Effects of Osteopathic Techniques on Residual Volume in Severe Chronic Obstructive Pulmonary Disease

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