Fascia; InflammationNCT04411095
The Effect of the Release of the Intrathoracic Fascia on Thoracic Rotation Mobility
A study testing Measuring thoracic rotation mobility in people with Fascia; Inflammation and Thoracic, run by International Academy of Osteopathy at 1 site in Belgium.
Trial summary
Testing the effect of a specific stretch technique versus sham treatment, to objectify the influence of that specific technique on thoracic rotation mobility. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fascia; Inflammation, Thoracic, Rotation
- What is being tested?
- Measuring thoracic rotation mobility
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Feb 2020to 1 Apr 2020
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects between the age of 18 and 65
- Both men and women
Who cannot join
- Structural disease of cervical or/and thoracic spine and/or head and/or thorax
- Acute mobility restriction of cervical and/or thoracic spine
- Acute and/or intense pain
- A history of trauma and/or operation on cervical and/or thoracic spine
- Treatment for cancer like chemo or radiation
- Baby's and children
- Elderly people
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Practice for fysiotherapy and osteopathy
Scherpenheuvel, Vlaams-brabant, 3270
About this study
Testing the effect of a specific stretch technique versus sham treatment, to objectify the influence of that specific technique on thoracic rotation mobility.
Read the detailed description
Subjects in the experimental group will undergo a technique for stretching the intrathoracic fascia. Before and after, a measurement will be performed with a goniometer, to see if there is a difference in thoracic rotation mobility.
Subjects in the placebo group get a different technique, where the hands of the therapists are simply placed on the thorax, but no manoeuvre will be performed. Before and after, there is a measurement in thoracic rotation mobility.
Data will be compared and statistical analyse will be done to see of there is a difference in rotation. So the hypothesis that stretching intrathoracic fascia has an effect on thoracic rotation mobility, will be accepted or rejected.
- Conditions
- Fascia; Inflammation, Thoracic, Rotation
- Being tested
- Measuring thoracic rotation mobility
- Medical subject headings
- Fasciitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring thoracic rotation mobilityOther
Measuring the thoracic rotation mobility with a goniometer, from a standardized position
| Study group | Role | What they receive |
|---|---|---|
| Stretching of intrathoracic fascia | Experimental | A technique will be used to stretch the intrathoracic fascia. The subject lies in his/her back, and a flexion of the upper cervical spine is combined with a retraction movement of the lower cervical and upper thoracic spine, this in combination with inspiration. Receives: Other: Measuring thoracic rotation mobility |
| Test without stretching | Placebo comparator | A placebo technique is performed by positioning the hands of the therapist on the thorax without pressure or performing a technique. Similar as the stretching technique, a deep inspiration is performed by the patient, for each of the intrathoracic cilinders. This without performing a retraction of the lower cervical and upper thoracic spine. Receives: Other: Measuring thoracic rotation mobility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in thoracic rotation mobility
Change from baseline rotation, left and right, to rotation immediately after the test
Measured: Before and immediately after the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start28 Feb 2020
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fascia; InflammationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Academy of Osteopathy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- IAO Administration, Study director, The International Academy of Osteopathy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411095
- Sponsor's protocol ID
- InternationalIAO
- Status last verified
- May 2020
- First submitted
- 22 Apr 2020
- Last updated
- 2 Jun 2020
- 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 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Release of the Intrathoracic Fascia on Thoracic Rotation Mobility
- ClinicalTrials.gov ID
- NCT04411095
- Acronym / sponsor ID
- InternationalIAO
- Conditions
- Fascia; Inflammation, Thoracic, Rotation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- International Academy of OsteopathyUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 2 Jun 2020 (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.
Testing the effect of a specific stretch technique versus sham treatment, to objectify the influence of that specific technique on thoracic rotation mobility.
Detailed description
Subjects in the experimental group will undergo a technique for stretching the intrathoracic fascia. Before and after, a measurement will be performed with a goniometer, to see if there is a difference in thoracic rotation mobility.
Subjects in the placebo group get a different technique, where the hands of the therapists are simply placed on the thorax, but no manoeuvre will be performed. Before and after, there is a measurement in thoracic rotation mobility.
Data will be compared and statistical analyse will be done to see of there is a difference in rotation. So the hypothesis that stretching intrathoracic fascia has an effect on thoracic rotation mobility, will be accepted or rejected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stretching of intrathoracic fascia | Experimental | Other: Measuring thoracic rotation mobilityA technique will be used to stretch the intrathoracic fascia. The subject lies in his/her back, and a flexion of the upper cervical spine is combined with a retraction movement of the lower cervical and upper thoracic spine, this in combination with inspiration. |
| Test without stretching | Placebo comparator | Other: Measuring thoracic rotation mobilityA placebo technique is performed by positioning the hands of the therapist on the thorax without pressure or performing a technique. Similar as the stretching technique, a deep inspiration is performed by the patient, for each of the intrathoracic cilinders. This without performing a retraction of the lower cervical and upper thoracic spine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects between the age of 18 and 65
- Both men and women
Key exclusion criteria (7 listed)
- Structural disease of cervical or/and thoracic spine and/or head and/or thorax
- Acute mobility restriction of cervical and/or thoracic spine
- Acute and/or intense pain
- A history of trauma and/or operation on cervical and/or thoracic spine
- Treatment for cancer like chemo or radiation
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 |
|---|---|---|
| Measuring thoracic rotation mobilityMeasuring the thoracic rotation mobility with a goniometer, from a standardized position | Other | Stretching of intrathoracic fascia, Test without stretching |
Primary outcome
Change in thoracic rotation mobility
Time frame: Before and immediately after the test
Change from baseline rotation, left and right, to rotation immediately after the test
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 2 Jun 2020.
- 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.
IAO Administration study director
The International Academy of Osteopathy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measuring thoracic rotation mobility in people with Fascia; Inflammation and Thoracic, run by International Academy of Osteopathy at 1 site in Belgium.
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 2 inclusion and 7 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 2 Jun 2020. 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 Belgium. 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?
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?
Change in thoracic rotation mobility (time frame: Before and immediately after the test). 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 2 Jun 2020.