Pulmonary Function TestNCT05817565
Physical Therapy on Phrenic Nerve Function
An observational study of Pulmonary Function Test and Phrenic Nerve Irritation, run by Cairo University at 1 site in Egypt.
Trial summary
This study was conducted to investigate the effects of a designed physical therapy program on respiratory function and phrenic nerve activity in cervical disc compression. Read more about this study
- Who is it for?
- Ages 40 to 45 years
- Conditions the study is for
- Pulmonary Function Test, Phrenic Nerve Irritation, Cervical Disc Lesion
- What is being tested?
- Ultrasound (Phyaction 190 I); with a frequency of 3 MHz was used
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 30 May 2023
- Phase
- Observational
- 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 40 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: study was conducted on 20 patients with compression of the cervical disc at the level of 3, 4, and 5. Their mean age was 43 years; mean weight was 75 kg and mean height was 170cm.They suffered from cervical disc compression for 6-8 months.
Who may be able to join
- suffered from cervical disc compression for 6-8 months.
- patients examined and referred by physician.
Who cannot join
- Any cardio pulmonary disorders which may alter pulmonary function.
- They did not receive any physical therapy program prior to their participation in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Giza, Ben El Sarayat
NISREEN A EL AHASS, PROF, 0237969108, nissreen.elnahas@cu.edu.eg
assma f attalah, 00201117744974, Zayedsameh40@yahoo.com
About this study
Official title: Outcomes of Physical Therapy Program on Respiratory and Phrenic Nerve Functions in Cervical Disc Compression
This study was conducted to investigate the effects of a designed physical therapy program on respiratory function and phrenic nerve activity in cervical disc compression.
Read the detailed description
Twenty patients from the Spinal Unite represented the sample of the study. Their mean ages were 43 years and they suffering from acute cervical disc compression at the level of cervical 3, 4, 5. Methods: Evaluation was carried out before and after three months of treatment. It included measuring of pulmonary functions (VC, FVC, FEV1, PEF and MVV) by using spirometer, diaphragmatic excursion and thoracic volume via x-ray and conduction velocity and amplitude of phrenic nerve using electromyography. Treatment program included heat application, ultrasound, cervical traction and diaphragmatic breathing exercises.
- Being tested
- Ultrasound (Phyaction 190 I); with a frequency of 3 MHz was used
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound (Phyaction 190 I); with a frequency of 3 MHz was usedDevice
Also called Cervical traction (Eltrac 471); for widening of cervical disc space.
Intermittent cervical traction (traction force equal 8% of body weight) was applied with the patient lying supine and the head in neutral position.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Patients underwent physical therapy program 3days/week for three months in the form of
* Heat therapy by using infrared on the cervical region for relaxation of spasmed neck muscles, while the patient in sitting position.
* While the patient is sitting, the ultrasound was applied on the para spinal muscles of cervical region for controlling pain.
* Intermittent cervical traction (traction force equal 8% of body weight) was applied with the patient lying supine and the head in neutral position. Receives: Device: Ultrasound (Phyaction 190 I); with a frequency of 3 MHz was used |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary function test
to measure vital capacity
Measured: 4 months
phrenic nerve amplitude
objective method to detect phrenic nerve function
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Feb 2023
- Primary completion15 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Function TestStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Takey Ahmed, Cairo University
- Investigators
- Maha m El monem, Ass Prof, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817565
- Sponsor's protocol ID
- respiration and phrenic
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carvalho, M. De (2004) Electrodiagnostic assessment of respiratory dysfunction in motor neuron disease, Handbook of Clinical Neurophysiology. Elsevier B.V. doi: 10.1016/S1567-4231(04)04029-8.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Physical Therapy Program on Respiratory and Phrenic Nerve Functions in Cervical Disc Compression
- ClinicalTrials.gov ID
- NCT05817565
- Acronym / sponsor ID
- respiration and phrenic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 18 Apr 2023 (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.
This study was conducted to investigate the effects of a designed physical therapy program on respiratory function and phrenic nerve activity in cervical disc compression.
Detailed description
Twenty patients from the Spinal Unite represented the sample of the study. Their mean ages were 43 years and they suffering from acute cervical disc compression at the level of cervical 3, 4, 5. Methods: Evaluation was carried out before and after three months of treatment. It included measuring of pulmonary functions (VC, FVC, FEV1, PEF and MVV) by using spirometer, diaphragmatic excursion and thoracic volume via x-ray and conduction velocity and amplitude of phrenic nerve using electromyography. Treatment program included heat application, ultrasound, cervical traction and diaphragmatic breathing exercises.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention group | – | Device: Ultrasound (Phyaction 190 I); with a frequency of 3 MHz was usedPatients underwent physical therapy program 3days/week for three months in the form of * Heat therapy by using infrared on the cervical region for relaxation of spasmed neck muscles, while the patient in sitting position. * While the patient is sitting, the ultrasound was applied on the para spinal muscles of cervical region for controlling pain. * Intermittent cervical traction (traction force equal 8% of body weight) was applied with the patient lying supine and the head in neutral position. |
Who may qualify
- Ages
- 40 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- study was conducted on 20 patients with compression of the cervical disc at the level of 3, 4, and 5. Their mean age was 43 years; mean weight was 75 kg and mean height was 170cm.They suffered from cervical disc compression for 6-8 months.
Key inclusion criteria (2 listed)
- suffered from cervical disc compression for 6-8 months.
- patients examined and referred by physician.
Key exclusion criteria (2 listed)
- Any cardio pulmonary disorders which may alter pulmonary function.
- They did not receive any physical therapy program prior to their participation in the study.
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 |
|---|---|---|
| Ultrasound (Phyaction 190 I); with a frequency of 3 MHz was usedAlso: Cervical traction (Eltrac 471); for widening of cervical disc space.Intermittent cervical traction (traction force equal 8% of body weight) was applied with the patient lying supine and the head in neutral position. | Device | intervention group |
Primary outcome
pulmonary function test
Time frame: 4 months
to measure vital capacity
phrenic nerve amplitude
Time frame: 4 months
objective method to detect phrenic nerve function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- BackgroundCarvalho, M. De (2004) Electrodiagnostic assessment of respiratory dysfunction in motor neuron disease, Handbook of Clinical Neurophysiology. Elsevier B.V. doi: 10.1016/S1567-4231(04)04029-8.
- 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.
Maha m El monem, Ass Prof study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Function Test and Phrenic Nerve Irritation, run by Cairo University at 1 site in Egypt.
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 2 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 18 Apr 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KHALED T AHMED, Asso Prof (01115586016, khaled.takey@must.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary function test (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05817565, which also lists 1 linked publication.
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 18 Apr 2023.