HyperkyphosisNCT06621667
Diaphragmatic Myofascial Release for Hyperkyphotic Subjects
A study testing diaphragmatic myofascial release with traditional physical therapy exercises for hyperkyphosis and traditional physical therapy exercises for hyperkyphosis in people with Hyperkyphosis, run by Cairo University.
Trial summary
kyphotic subjects have respiratory disturbances due to weakening of the diaphragm, responsible for inhalation, which lead to abnormalities in respiratory mechanics and abnormal gas exchange, leading to respiratory complications. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Hyperkyphosis
- What is being tested?
- diaphragmatic myofascial release with traditional physical therapy exercises for hyperkyphosis and traditional physical therapy exercises for hyperkyphosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2024to 30 Dec 2024
- 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
- No healthy volunteers
- Adult
Who may be able to join
- The participant's age ranged from 20 to 40 years.
- kyphosis angle 40-50◦
- reporting pain on palpation of the diaphragm
Who cannot join
- A history of respiratory diseases, heart disease, vascular disease, central nervous system disorder, psychiatric disorders, hypertension.
- History of any trauma or fracture to the thoracic spine.
- inflammatory diseases such as rheumatoid arthritis, musculoskeletal problem and neurological deficit
- Restrictive respiratory disease, smokers.
About this study
Official title: Response of Lung Function, Chest Mobility, and Kyphotic Curve to Diaphragmatic Myofascial Release in Hyperkyphotic Subjects: A Randomized Controlled Trial
kyphotic subjects have respiratory disturbances due to weakening of the diaphragm, responsible for inhalation, which lead to abnormalities in respiratory mechanics and abnormal gas exchange, leading to respiratory complications. Myofascial release of the diaphragm is an intervention intended to indirectly stretch the diaphragm muscle fibers to reduce muscle tension, normalize fiber length, and promote the efficiency of muscle contraction. Although diaphragm myofascial release has been used in clinical practice, to the best of the authors' knowledge, the current study is the first research investigating the effect of diaphragmatic myofascial release on lung function, chest mobility and kyphotic curve in hyperkyphotic subjects.
- Conditions
- Hyperkyphosis
- Being tested
- diaphragmatic myofascial release with traditional physical therapy exercises for hyperkyphosis, traditional physical therapy exercises for hyperkyphosis
- Medical subject headings
- Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaphragmatic myofascial release with traditional physical therapy exercises for hyperkyphosisOther
diaphragmatic myofascial release
traditional physical therapy exercises for hyperkyphosisOther
traditional physical therapy exercises for hyperkyphosis
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Not described Receives: Other: diaphragmatic myofascial release with traditional physical therapy exercises for hyperkyphosis |
| control group | Active comparator | Not described Receives: Other: traditional physical therapy exercises for hyperkyphosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum voluntary ventilation
the maximum voluntary ventilation will be measured using spirometer
Measured: change from base line at 4 weeks.
Secondary outcomes (2)
Chest expansion
the chest expansion will be measured using tap measurement
Measured: change from base line at 4 weeks.
kyphotic angle
the kyphotic angle will be measured with flexicurve
Measured: change from base line at 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start10 Oct 2024 (estimated)
- Primary completion20 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkyphosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Shafiek Mustafa Saleh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621667
- Sponsor's protocol ID
- myorelease for hyperkyphosis
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of Lung Function, Chest Mobility, and Kyphotic Curve to Diaphragmatic Myofascial Release in Hyperkyphotic Subjects: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06621667
- Acronym / sponsor ID
- myorelease for hyperkyphosis
- Conditions
- Hyperkyphosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (estimated)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 1 Oct 2024 (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.
kyphotic subjects have respiratory disturbances due to weakening of the diaphragm, responsible for inhalation, which lead to abnormalities in respiratory mechanics and abnormal gas exchange, leading to respiratory complications. Myofascial release of the diaphragm is an intervention intended to indirectly stretch the diaphragm muscle fibers to reduce muscle tension, normalize fiber length, and promote the efficiency of muscle contraction. Although diaphragm myofascial release has been used in clinical practice, to the best of the authors' knowledge, the current study is the first research investigating the effect of diaphragmatic myofascial release on lung function, chest mobility and kyphotic curve in hyperkyphotic subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: diaphragmatic myofascial release with traditional physical therapy exercises for hyperkyphosis |
| control group | Active comparator | Other: traditional physical therapy exercises for hyperkyphosis |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The participant's age ranged from 20 to 40 years.
- kyphosis angle 40-50◦
- reporting pain on palpation of the diaphragm
Key exclusion criteria (4 listed)
- A history of respiratory diseases, heart disease, vascular disease, central nervous system disorder, psychiatric disorders, hypertension.
- History of any trauma or fracture to the thoracic spine.
- inflammatory diseases such as rheumatoid arthritis, musculoskeletal problem and neurological deficit
- Restrictive respiratory disease, smokers.
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 |
|---|---|---|
| diaphragmatic myofascial release with traditional physical therapy exercises for hyperkyphosisdiaphragmatic myofascial release | Other | study group |
| traditional physical therapy exercises for hyperkyphosistraditional physical therapy exercises for hyperkyphosis | Other | control group |
Primary outcome
maximum voluntary ventilation
Time frame: change from base line at 4 weeks.
the maximum voluntary ventilation will be measured using spirometer
2 secondary outcomes
Chest expansion
Time frame: change from base line at 4 weeks.
kyphotic angle
Time frame: change from base line at 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing diaphragmatic myofascial release with traditional physical therapy exercises for hyperkyphosis and traditional physical therapy exercises for hyperkyphosis in people with Hyperkyphosis, run by Cairo University.
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 3 inclusion and 4 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 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
maximum voluntary ventilation (time frame: change from base line at 4 weeks.). 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 1 Oct 2024.