Diaphragm; RelaxationNCT05197907
Influence of Manual Relaxation of the Diaphragm on the Tension of the Posterior Superficial Fascia
A study testing Fascial release of diaphragm muscle. and Classic massage of the abdomen. in people with Diaphragm; Relaxation and Low Back Pain, run by Jagiellonian University at 1 site in Poland.
Trial summary
The diaphragm performs many functions that are vital to the body as a whole. Some of them are not related only to ventilation. The diaphragm is part of the myofascial system in the human body. Therefore, the proper functioning of the diaphragm should be a significant element of physiotherapy, e.g. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Diaphragm; Relaxation, Low Back Pain
- What is being tested?
- Fascial release of diaphragm muscle. and Classic massage of the abdomen.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 sitePoland
- Study dates
- 1 Aug 2021to 30 Jul 2022
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age within 20-40 yrs,
- BMI within normal range (18.5-24.9)
- lack of abdominal obesity
- lack of chronic musculoskeletal conditions
- written, conscious consent
Who cannot join
- former abdominal surgery
- abdominal diseases (i.e. (np. kidney stones, ulcers, irritative bowel sindrome, etc.),
- pregnancy
- fever,
- tumors,
- blood hypertension,
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- former surgery of respiratory system ,
- condition after surgical procedures in the area of the spine,
- the occurrence of pain in the spine in the 3 months preceding the research experiment,
- lack of conscious consent
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Jagiellonian University Medical College
Krakow
Roksana Wójcik, MSc, 12 6343397 ext. +48, roksanaa.wojcik@student.uj.edu.pl
About this study
The diaphragm performs many functions that are vital to the body as a whole. Some of them are not related only to ventilation. The diaphragm is part of the myofascial system in the human body. Therefore, the proper functioning of the diaphragm should be a significant element of physiotherapy, e.g. in patients reporting pain in the lumbosacral spine.
Considering the complex role of the diaphragm, it seems reasonable to investigate the influence of the mobilization of the diaphragm (aimed at reducing diaphragm tension) on the tension of the extensor muscles of the lumbar spine.
Read more
The assumption of this reserach is to investigate the correlation between the tension of the fascia in the area of the diaphragm to the tension of the muscles in the area of the lumbar spine. The fascial connections between the diaphragm and the muscles in the lumbar spine presented above suggest that the manual therapy performed within the diaphragm can effectively prevent the occurrence of pain, and might be a supportive measure in the treatment of pain in the spine.
The aim of the study is to investigate the corellation between the tension of the fascia within the diaphragm and the tension of the posterior superficial tape.
Research questions:
- How does manual therapy in the area of the tendon attachments of the diaphragm affect the relaxation of the extensor muscles of the lumbar spine?
- How can the therapy conducted only within the diaphragm, without interfering with the structures surrounding the spine, reduce the tension of the extensor muscles of the lumbar spine and, consequently, increase the range of its mobility in all planes?
- How will the introduced therapy change the tidal volume of the lungs?
- Conditions
- Diaphragm; Relaxation, Low Back Pain
- Being tested
- Fascial release of diaphragm muscle., Classic massage of the abdomen.
- Keywords
- diaphragm, low back pain, deep tissue massage, diaphragm relaxation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascial release of diaphragm muscle.Procedure or surgery
The intervention consists of deep tissue massage techniques and manual mobilization of the fascia performed within the diaphragm attachments in the area of the costal arches.
Classic massage of the abdomen.Procedure or surgery
The intervention consists of selected classic massage techniques - mainly stroking (effleurage) - performed on the superficial layers of the abdominal region
| Study group | Role | What they receive |
|---|---|---|
| Diaphragm fascial release group. | Experimental | Ten minutes lasting fascial release techinques performed on diaphragm. Receives: Procedure: Fascial release of diaphragm muscle. |
| Classic massage group | Placebo comparator | Ten minutes lasting classic massage performed on abdomen. Receives: Procedure: Classic massage of the abdomen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessemnt of change in muscle tension of selected muscles of lumbar region
Assessment of muscle superficial electromyography will be performed with sEMG device NuTrac Alpha2E (NeuroTrac Ltd.) on the following muscles: multifidus, longissimus and iliocostalis.
Measured: Twice - before and immediately after the treatment procedure
Secondary outcomes (2)
Assessment of change of range of motion of the lumbar spine.
The range of motion of the lumbar spine will be performed with the digital inclinometer (Baseline)
Measured: Twice - before and immediately after the treatment procedure
Assessment of change in peak expiratory flow in one second (PEF1)
The peak expiratory flow in one second will be performed with PF100 peakflometer (Microlife).
Measured: Twice - before and immediately after the treatment procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Aug 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragm; RelaxationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roksana Wójcik, Jagiellonian University
- Investigators
- Bartosz Trybulec, PhD, Study chair, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197907
- Sponsor's protocol ID
- N43/DBS/000115
- Status last verified
- Jan 2022
- First submitted
- 27 Dec 2021
- Last updated
- 20 Jan 2022
- 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 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Manual Relaxation of the Diaphragm on the Tension of the Posterior Superficial Fascia
- ClinicalTrials.gov ID
- NCT05197907
- Acronym / sponsor ID
- N43/DBS/000115
- Conditions
- Diaphragm; Relaxation, Low Back Pain
- Keywords
- diaphragm, low back pain, deep tissue massage, diaphragm relaxation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 20 Jan 2022 (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.
The diaphragm performs many functions that are vital to the body as a whole. Some of them are not related only to ventilation. The diaphragm is part of the myofascial system in the human body. Therefore, the proper functioning of the diaphragm should be a significant element of physiotherapy, e.g. in patients reporting pain in the lumbosacral spine.
Considering the complex role of the diaphragm, it seems reasonable to investigate the influence of the mobilization of the diaphragm (aimed at reducing diaphragm tension) on the tension of the extensor muscles of the lumbar spine.
The assumption of this reserach is to investigate the correlation between the tension of the fascia in the area of the diaphragm to the tension of the muscles in the area of the lumbar spine. The fascial connections between the diaphragm and the muscles in the lumbar spine presented above suggest that the manual therapy performed within the diaphragm can effectively prevent the occurrence of pain, and might be a supportive measure in the treatment of pain in the spine.
The aim of the study is to investigate the corellation between the tension of the fascia within the diaphragm and the tension of the posterior superficial tape.
Research questions:
- How does manual therapy in the area of the tendon attachments of the diaphragm affect the relaxation of the extensor muscles of the lumbar spine?
- How can the therapy conducted only within the diaphragm, without interfering with the structures surrounding the spine, reduce the tension of the extensor muscles of the lumbar spine and, consequently, increase the range of its mobility in all planes?
- How will the introduced therapy change the tidal volume of the lungs?
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragm fascial release group. | Experimental | Procedure: Fascial release of diaphragm muscle.Ten minutes lasting fascial release techinques performed on diaphragm. |
| Classic massage group | Placebo comparator | Procedure: Classic massage of the abdomen.Ten minutes lasting classic massage performed on abdomen. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age within 20-40 yrs,
- BMI within normal range (18.5-24.9)
- lack of abdominal obesity
- lack of chronic musculoskeletal conditions
- written, conscious consent
Key exclusion criteria (10 listed)
- former abdominal surgery
- abdominal diseases (i.e. (np. kidney stones, ulcers, irritative bowel sindrome, etc.),
- pregnancy
- fever,
- tumors,
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 |
|---|---|---|
| Fascial release of diaphragm muscle.The intervention consists of deep tissue massage techniques and manual mobilization of the fascia performed within the diaphragm attachments in the area of the costal arches. | Procedure or surgery | Diaphragm fascial release group. |
| Classic massage of the abdomen.The intervention consists of selected classic massage techniques - mainly stroking (effleurage) - performed on the superficial layers of the abdominal region | Procedure or surgery | Classic massage group |
Primary outcome
Assessemnt of change in muscle tension of selected muscles of lumbar region
Time frame: Twice - before and immediately after the treatment procedure
Assessment of muscle superficial electromyography will be performed with sEMG device NuTrac Alpha2E (NeuroTrac Ltd.) on the following muscles: multifidus, longissimus and iliocostalis.
2 secondary outcomes
Assessment of change of range of motion of the lumbar spine.
Time frame: Twice - before and immediately after the treatment procedure
Assessment of change in peak expiratory flow in one second (PEF1)
Time frame: Twice - before and immediately after the treatment procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- 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 Trybulec, PhD study chair
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascial release of diaphragm muscle. and Classic massage of the abdomen. in people with Diaphragm; Relaxation and Low Back Pain, 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 5 inclusion and 10 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 20 Jan 2022. 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 Roksana S. Wójcik, MSc (12 634 33 97 ext. +48, roksanaa.wojcik@student.uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessemnt of change in muscle tension of selected muscles of lumbar region (time frame: Twice - before and immediately after the treatment procedure). 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 Jan 2022.