COPDNCT02755363
Effects of Osteopathic Techniques on Residual Volume in Severe Chronic Obstructive Pulmonary Disease
A study testing osteopathic manual therapy in people with COPD, run by Medical University of Warsaw at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- COPD
- What is being tested?
- osteopathic manual therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- Apr 2016to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- exacerbation in the past 6 weeks,
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Departament of Internal Medicine, Pneumonology and Allergology, Warsaw Medical University
Warsaw, 02-097
Katarzyna Górska, PhD, +48501077180, drkpgorska@gmail.com
About this study
Official title: Evaluation of the Immediate Effects of Osteopathic Techniques on Plethysmographic Measurement of Residual Volume in Patients With Severe Chronic Obstructive Pulmonary Disease
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).
Read the 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.
- Conditions
- COPD
- Being tested
- osteopathic manual therapy, control group
- Keywords
- COPD, residual volume, osteopathy, hyperinflation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteopathic manual therapyOther
- 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 groupOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| osteopathic manual therapy (OMT group) | Active comparator | patients who will undergo manual osteopathic therapy. Receives: Other: osteopathic manual therapy |
| control group (C group) | Placebo comparator | patients who will undergo manual therapy not aimed to decrease hyperinflation. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katarzyna Górska, PhD, MD, Principal investigator, WMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755363
- Sponsor's protocol ID
- WarsawMU
- Status last verified
- Apr 2016
- First submitted
- 19 Apr 2016
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Immediate Effects of Osteopathic Techniques on Plethysmographic Measurement of Residual Volume in Patients With Severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02755363
- Acronym / sponsor ID
- WarsawMU
- Conditions
- COPD
- Keywords
- COPD, residual volume, osteopathy, hyperinflation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| osteopathic manual therapy (OMT group) | Active comparator | Other: osteopathic manual therapypatients who will undergo manual osteopathic therapy. |
| control group (C group) | Placebo comparator | Other: control grouppatients who will undergo manual therapy not aimed to decrease hyperinflation. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- exacerbation in the past 6 weeks,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | osteopathic manual therapy (OMT group) |
| 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. | Other | control group (C group) |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarzyna Górska, PhD, MD principal investigator
WMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing osteopathic manual therapy in people with COPD, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna Górska, PhD, MD (+48501077180, drkpgorska@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2016.