NCT05817565

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

April 5, 2023

Last Update Submit

April 17, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • pulmonary function test

    to measure vital capacity

    4 months

  • phrenic nerve amplitude

    objective method to detect phrenic nerve function

    4 months

Study Arms (1)

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

Interventions

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

Also known as: Cervical traction (Eltrac 471); for widening of cervical disc space.
intervention group

Eligibility Criteria

Age40 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Ben El Sarayat, Egypt

RECRUITING

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Maha m El monem, Ass Prof

    Cairo University

    STUDY CHAIR

Central Study Contacts

KHALED T AHMED, Asso Prof

CONTACT

abla h saleh, prof

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asssociate Professor

Study Record Dates

First Submitted

April 5, 2023

First Posted

April 18, 2023

Study Start

February 1, 2023

Primary Completion

May 15, 2023

Study Completion

May 30, 2023

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations