SpirometryNCT05093179
The Effect of Deep Tissue Massage on Respiratory Parameters in Healthy People
A study testing Deep tissue massage and Classic massage in people with Spirometry and Massage, run by Jagiellonian University at 1 site in Poland.
Trial summary
Deep tissue massage (DTM), based on deep palpation and elimination of fascia restrictions, can reduce symptoms resulting from fascial disorders. The goal of this study was the analysis of the DTM effect on respiratory parameters in healthy people. Read more about this study
- Who is it for?
- Ages 19 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Spirometry, Massage
- What is being tested?
- Deep tissue massage and Classic massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2019to 31 Mar 2019
- 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 19 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physical activity of minimum 30 min. duration, at least 3 times a week.
- No chest injuries.
- No contraindications for DTM/classic massage.
- No serious diseases of the respiratory and/or cardiovascular systems.
- No tobacco products smoking (incl.e-smoking).
- No posture defects that could affect the chest mobility.
Who cannot join
- Contraindications to DTM/classic massage of the chest.
- Occurrence of serious diseases of the respiratory/cardiovascular system now or in the past.
- Lack of or low physical activity (< 30 min min. 3 times per week).
- Tobacco smoking (incl.e-smoking).
- Chest injuries.
- Posture defects that may affect the chest mobility.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Institute of Physiotherapy Jagiellonian University Medical College
Krakow, 31-126
About this study
Deep tissue massage (DTM), based on deep palpation and elimination of fascia restrictions, can reduce symptoms resulting from fascial disorders. The goal of this study was the analysis of the DTM effect on respiratory parameters in healthy people. People of both sexes living in the city of Cracow were recruited to the study by the authors personally and through social media. An original questionnaire was completed in the presence of the examiner in order to collect the participants characteristics data. Questions about past diseases, previous surgical procedures or injuries, currently taken medications or the level of physical activity were asked to check the inclusion/exclusion criteria. The study involved a group of 40 people divided into two subgroups. The experimental group underwent a single DTM session. Classic massage was performed in the control group. Before and after treatment the lung vital capacity, chest circumference and oxygen saturation were measured and a spirometry test was performed. The main hypothesis assumed that static respiratory parameters should increase after the treatment session more in the experimental than in control group while the dynamic respiratory parameters would not differ significantly in both groups before and after treatment.
- Conditions
- Spirometry, Massage
- Being tested
- Deep tissue massage, Classic massage
- Keywords
- deep tissue, massage, spirometry, chest, fascial release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep tissue massageProcedure or surgery
Administered as a soft tissue mobilization performed by the therapist with fingertips, knuckles, elbows and/or fists on the tissues that manifest symptoms of fascial restrictions. The techniques were performed with individually adjusted force until the change (eg. increased mobility) in the tissue being treated was stated by the therapist.
Classic massageProcedure or surgery
The subject was lying supine on the table, with a roller placed under the knee joints, the upper limbs along the body. The following sequence of techniques was used in the longitudinal and transverse strands and in the intercostal spaces (excluding the breast in women): effleurage, friction, petrissage, pressures, tapotement and vibrations.
| Study group | Role | What they receive |
|---|---|---|
| Deep tissue massage group | Experimental | The one session of deep tissue massage was performed. The patient's positions were changed depending on the specificity of used techniques.
The following techniques were used:
* Shifting the rectus abdominis m.,
* Stretching of the fascia within the costal arches,
* trigger points compression (30-60 s).
* Stretching of the chest fascia, superficially with forearm or fingertips on intercostal muscles,
* "filleting" the pectoral muscles,
* "hook and stretch" with the proximal phalanges of the fingers 2-4 and the forearm
* "filleting" between the pectoral muscles and the deltoids,
* Releasing the lateral edge of the scapula using the fingers and stretching the tissues, Releasing the medial edge of the scapula using the fingers and the weight of the patient,
* "hook and stretch" of the trapezius muscle,
* Subsequently, the patient took a prone position.
* Stretching of the levator scapulae and supraspinatus muscles using the fist, forearm and elbow were performed. Receives: Procedure: Deep tissue massage |
| Classic massage group | Active comparator | The one session of classic massage was performed. The massage was performed with moderate force. The entire procedure took about 15-20 min. The sequence of standard classic massage techniques was used in standard way and patterns. Receives: Procedure: Classic massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change of lung vital capacity
The vital capacity of the lungs was assessed with spirotest (Riester, mod. 5260). The subject stood with legs hip-width apart. For each measurement, disposable cardboard mouthpieces were used. The examined person held the device vertically with both hands. At the examiner's command, subject took in as much air as possible, then tightly bit the mouthpiece with his mouth, and with all of their strength, exhaled air into the device for as long as possible. The subject had only 1 attempt-measured values were recorded with an accuracy of 50 mL.
Measured: twice: before and immediately after procedure administration in both groups
Assessment of change of blood oxygen saturation
Testing blood oxygen saturation was performed in a sitting position with digital pulseoximeter CMS50D. The device was put on the second finger of the left hand each time. The highest value displayed by the pulseoximeter within 30 s was recorded with an accuracy of 1%.
Measured: twice: before and immediately after procedure administration in both groups
Assessment of change of chest circumference
The chest circumference was measured with a measuring tape, wrapped horizontally around the chest at the level of the xiphoid process. The subject was standing with feet hip-width apart, arms hanging along the body. At the command, the subject would take a maximum breathe in (first measurement) and exhale to the maximum for the next (second measurement). Obtained values were recorded with an accuracy of 0.5 cm.
Measured: twice: before and immediately after procedure administration in both groups
Asessment of change of Peak Expiratory Flow
Dynamic spirometry test was performed, assessing the peak expiratory flow (PEF) measured in liters per second [l/s]. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting with his legs on the floor-hip joint flexed at an angle of 70o-90o and carried out the following command: "Breathe calmly. On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ". This cycle was performed at least 3 times obtaining 3 measurements according to the standard ERSATS 2005.
Measured: twice: before and immediately after procedure administration in both groups
Assessment of change of Peak Inspiratory Flow
Dynamic spirometry test was performed, assessing the peak inspiratory flow (PIF) measured in liters per second [l/s]. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting with his legs on the floor-hip joint flexed at an angle of 70o-90o and carried out the following command: "Breathe calmly. On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ". This cycle was performed at least 3 times obtaining 3 measurements according to the standard ERSATS 2005.
Measured: twice: before and immediately after procedure administration in both groups
Assessment of change of Forced Vital Capacity
Dynamic spirometry test was performed, assessing the forced vital capacity (FVC), measured in liters. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting with his legs on the floor-hip joint flexed at an angle of 70o-90o and carried out the following command: "Breathe calmly. On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ".
Measured: twice: before and immediately after procedure administration in both groups
Assessment of change of Maximum Expiratory Flow.
Dynamic spirometry test was performed, assessing the maximum expiratory flow (MEF), measured in liters per second. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting with his legs on the floor-hip joint flexed at an angle of 70o-90o and carried out the following command: "Breathe calmly. On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ". This cycle was performed at least 3 times obtaining 3 measurements according to the standard ERSATS 2005.
Measured: twice: before and immediately after procedure administration in both groups
Assessment of change of Forced Expiratory Volume
Dynamic spirometry test was performed, assessing the forced expiratory volume in 1 s (FEV1) measured in liters. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting with his legs on the floor-hip joint flexed at an angle of 70o-90o and carried out the following command: "Breathe calmly. On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ". This cycle was performed at least 3 times obtaining 3 measurements according to the standard ERSATS 2005.
Measured: twice: before and immediately after procedure administration in both groups
Assessment of change of Maximum Voluntary Ventilation
Dynamic spirometry test was performed, assessing the maximum voluntary ventilation (MVV) measured in liters per minute. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting with his legs on the floor-hip joint flexed at an angle of 70o-90o and carried out the following command: "Breathe calmly. On my command, inhale and exhale as quickly and as deeply as possible for 15 s until you hear the 'stop' command. This cycle was performed at least 3 times obtaining 3 measurements according to the standard ERSATS 2005.
Measured: twice: before and immediately after procedure administration in both groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Feb 2019
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpirometryStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bartosz Trybulec, Jagiellonian University
- Investigators
- Bartosz T. trybulec, PhD, Study director, Jagiellonian University Medical College in Cracow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093179
- Sponsor's protocol ID
- 1072.6120.7.2019
- Status last verified
- Mar 2025
- First submitted
- 30 Sep 2021
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Deep Tissue Massage on Respiratory Parameters in Healthy People
- ClinicalTrials.gov ID
- NCT05093179
- Acronym / sponsor ID
- 1072.6120.7.2019
- Conditions
- Spirometry, Massage
- Keywords
- deep tissue, massage, spirometry, chest, fascial release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 26 Oct 2021 (actual)
- 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.
Deep tissue massage (DTM), based on deep palpation and elimination of fascia restrictions, can reduce symptoms resulting from fascial disorders. The goal of this study was the analysis of the DTM effect on respiratory parameters in healthy people. People of both sexes living in the city of Cracow were recruited to the study by the authors personally and through social media. An original questionnaire was completed in the presence of the examiner in order to collect the participants characteristics data. Questions about past diseases, previous surgical procedures or injuries, currently taken medications or the level of physical activity were asked to check the inclusion/exclusion criteria. The study involved a group of 40 people divided into two subgroups. The experimental group underwent a single DTM session. Classic massage was performed in the control group. Before and after treatment the lung vital capacity, chest circumference and oxygen saturation were measured and a spirometry test was performed. The main hypothesis assumed that static respiratory parameters should increase after the treatment session more in the experimental than in control group while the dynamic respiratory parameters would not differ significantly in both groups before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep tissue massage group | Experimental | Procedure: Deep tissue massageThe one session of deep tissue massage was performed. The patient's positions were changed depending on the specificity of used techniques. The following techniques were used: * Shifting the rectus abdominis m., * Stretching of the fascia within the costal arches, * trigger points compression (30-60 s). * Stretching of the chest fascia, superficially with forearm or fingertips on intercostal muscles, * "filleting" the pectoral muscles, * "hook and stretch" with the proximal phalanges of the fingers 2-4 and the forearm * "filleting" between the pectoral muscles and the deltoids, * Releasing the lateral edge of the scapula using the fingers and stretching the tissues, Releasing the medial edge of the scapula using the fingers and the weight of the patient, * "hook and stretch" of the trapezius muscle, * Subsequently, the patient took a prone position. * Stretching of the levator scapulae and supraspinatus muscles using the fist, forearm and elbow were performed. |
| Classic massage group | Active comparator | Procedure: Classic massageThe one session of classic massage was performed. The massage was performed with moderate force. The entire procedure took about 15-20 min. The sequence of standard classic massage techniques was used in standard way and patterns. |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Physical activity of minimum 30 min. duration, at least 3 times a week.
- No chest injuries.
- No contraindications for DTM/classic massage.
- No serious diseases of the respiratory and/or cardiovascular systems.
- No tobacco products smoking (incl.e-smoking).
Key exclusion criteria (6 listed)
- Contraindications to DTM/classic massage of the chest.
- Occurrence of serious diseases of the respiratory/cardiovascular system now or in the past.
- Lack of or low physical activity (< 30 min min. 3 times per week).
- Tobacco smoking (incl.e-smoking).
- Chest injuries.
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 |
|---|---|---|
| Deep tissue massageAdministered as a soft tissue mobilization performed by the therapist with fingertips, knuckles, elbows and/or fists on the tissues that manifest symptoms of fascial restrictions. The techniques were performed with individually adjusted force until the change (eg. increased mobility) in the tissue being treated was stated by the therapist. | Procedure or surgery | Deep tissue massage group |
| Classic massageThe subject was lying supine on the table, with a roller placed under the knee joints, the upper limbs along the body. The following sequence of techniques was used in the longitudinal and transverse strands and in the intercostal spaces (excluding the breast in women): effleurage, friction, petrissage, pressures, tapotement and vibrations. | Procedure or surgery | Classic massage group |
Primary outcome
Assessment of change of lung vital capacity
Time frame: twice: before and immediately after procedure administration in both groups
The vital capacity of the lungs was assessed with spirotest (Riester, mod. 5260). The subject stood with legs hip-width apart. For each measurement, disposable cardboard mouthpieces were used. The examined person held the device vertically with both hands. At the examiner's command, subject took in as much air as possible, then tightly bit the mouthpiece with his mouth, and with all of their strength, exhaled air into the device for as long as possible. The subject had only 1 attempt-measured values were recorded with an accuracy of 50 mL.
Assessment of change of blood oxygen saturation
Time frame: twice: before and immediately after procedure administration in both groups
Testing blood oxygen saturation was performed in a sitting position with digital pulseoximeter CMS50D. The device was put on the second finger of the left hand each time. The highest value displayed by the pulseoximeter within 30 s was recorded with an accuracy of 1%.
Assessment of change of chest circumference
Time frame: twice: before and immediately after procedure administration in both groups
The chest circumference was measured with a measuring tape, wrapped horizontally around the chest at the level of the xiphoid process. The subject was standing with feet hip-width apart, arms hanging along the body. At the command, the subject would take a maximum breathe in (first measurement) and exhale to the maximum for the next (second measurement). Obtained values were recorded with an accuracy of 0.5 cm.
Asessment of change of Peak Expiratory Flow
Time frame: twice: before and immediately after procedure administration in both groups
Dynamic spirometry test was performed, assessing the peak expiratory flow (PEF) measured in liters per second [l/s]. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting with his legs on the floor-hip joint flexed at an angle of 70o-90o and carried out the following command: "Breathe calmly. On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ". This cycle was performed at least 3 times obtaining 3 measurements according to the standard ERSATS 2005.
Assessment of change of Peak Inspiratory Flow
Time frame: twice: before and immediately after procedure administration in both groups
Dynamic spirometry test was performed, assessing the peak inspiratory flow (PIF) measured in liters per second [l/s]. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting with his legs on the floor-hip joint flexed at an angle of 70o-90o and carried out the following command: "Breathe calmly. On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ". This cycle was performed at least 3 times obtaining 3 measurements according to the standard ERSATS 2005.
Assessment of change of Forced Vital Capacity
Time frame: twice: before and immediately after procedure administration in both groups
Dynamic spirometry test was performed, assessing the forced vital capacity (FVC), measured in liters. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting with his legs on the floor-hip joint flexed at an angle of 70o-90o and carried out the following command: "Breathe calmly. On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ".
Assessment of change of Maximum Expiratory Flow.
Time frame: twice: before and immediately after procedure administration in both groups
Dynamic spirometry test was performed, assessing the maximum expiratory flow (MEF), measured in liters per second. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting with his legs on the floor-hip joint flexed at an angle of 70o-90o and carried out the following command: "Breathe calmly. On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ". This cycle was performed at least 3 times obtaining 3 measurements according to the standard ERSATS 2005.
Assessment of change of Forced Expiratory Volume
Time frame: twice: before and immediately after procedure administration in both groups
Dynamic spirometry test was performed, assessing the forced expiratory volume in 1 s (FEV1) measured in liters. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting with his legs on the floor-hip joint flexed at an angle of 70o-90o and carried out the following command: "Breathe calmly. On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ". This cycle was performed at least 3 times obtaining 3 measurements according to the standard ERSATS 2005.
Assessment of change of Maximum Voluntary Ventilation
Time frame: twice: before and immediately after procedure administration in both groups
Dynamic spirometry test was performed, assessing the maximum voluntary ventilation (MVV) measured in liters per minute. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting with his legs on the floor-hip joint flexed at an angle of 70o-90o and carried out the following command: "Breathe calmly. On my command, inhale and exhale as quickly and as deeply as possible for 15 s until you hear the 'stop' command. This cycle was performed at least 3 times obtaining 3 measurements according to the standard ERSATS 2005.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Bartosz T. trybulec, PhD study director
Jagiellonian University Medical College in Cracow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep tissue massage and Classic massage in people with Spirometry and Massage, run by Jagiellonian University 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 20 Mar 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of change of lung vital capacity (time frame: twice: before and immediately after procedure administration in both groups). The study lists 9 primary outcomes in all. 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 20 Mar 2025.