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

COPD Clinical Trial

Official title:

Evaluation of the Immediate Effects of Osteopathic Techniques on Plethysmographic Measurement of Residual Volume in Patients With Severe Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02755363
• Other study ID #: WarsawMU
• Status: Recruiting
• Phase: N/A
• First received: April 19, 2016
• Last updated: April 28, 2016
• Start date: April 2016
• Est. completion date: July 2016

Study information

• Verified date: April 2016
• Source: Medical University of Warsaw
• Contact: Katarzyna Górska, PhD, MD
• Phone: +48501077180
• Email: drkpgorska[@]gmail.com
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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,

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• osteopathic manual therapy
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.
• control group
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.

Locations

Country	Name	City	State
Poland	Departament of Internal Medicine, Pneumonology and Allergology, Warsaw Medical University	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		40 minutes	Yes