Physical Therapy on Phrenic Nerve Function

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05817565

Collaborator

(none)

Enrollment

Location

3.9

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Function Test Phrenic Nerve Irritation Cervical Disc Lesion	Device: Ultrasound (Phyaction 190 I); with a frequency of 3 MHz was used

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

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Outcomes of Physical Therapy Program on Respiratory and Phrenic Nerve Functions in Cervical Disc Compression

Actual Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

May 15, 2023

Anticipated Study Completion Date :

May 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: Ultrasound (Phyaction 190 I); with a frequency of 3 MHz was used Intermittent cervical traction (traction force equal 8% of body weight) was applied with the patient lying supine and the head in neutral position. Other Names: Cervical traction (Eltrac 471); for widening of cervical disc space.

Arm

Intervention/Treatment

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.

Device: Ultrasound (Phyaction 190 I); with a frequency of 3 MHz was used

Intermittent cervical traction (traction force equal 8% of body weight) was applied with the patient lying supine and the head in neutral position.

Other Names:

Cervical traction (Eltrac 471); for widening of cervical disc space.

Outcome Measures

Primary Outcome Measures

pulmonary function test [4 months]
to measure vital capacity
phrenic nerve amplitude [4 months]
objective method to detect phrenic nerve function

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

suffered from cervical disc compression for 6-8 months.
patients examined and referred by physician.

Exclusion Criteria:

Any cardio pulmonary disorders which may alter pulmonary function.
They did not receive any physical therapy program prior to their participation in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Giza	Ben El Sarayat	Egypt

Sponsors and Collaborators

Cairo University

Investigators

Study Chair: Maha m El monem, Ass Prof, Cairo University

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Khaled Takey Ahmed, Asssociate Professor, Cairo University

ClinicalTrials.gov Identifier:

NCT05817565

Other Study ID Numbers:

respiration and phrenic

First Posted:

Apr 18, 2023

Last Update Posted:

Apr 18, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 18, 2023