NCT05093179

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

September 30, 2021

Last Update Submit

March 18, 2025

Conditions

Keywords

deep tissuemassagespirometrychestfascial release

Outcome Measures

Primary Outcomes (9)

  • 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.

    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%.

    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.

    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.

    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.

    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 ".

    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.

    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.

    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.

    twice: before and immediately after procedure administration in both groups

Study Arms (2)

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.

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.

Procedure: Classic massage

Interventions

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.

Deep tissue massage group

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.

Classic massage group

Eligibility Criteria

Age19 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Physiotherapy Jagiellonian University Medical College

Krakow, 31-126, Poland

Location

Study Officials

  • Bartosz T. trybulec, PhD

    Jagiellonian University Medical College in Cracow

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 30, 2021

First Posted

October 26, 2021

Study Start

February 1, 2019

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

March 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations