NCT06491992

Brief Summary

A phonophoresis-based drug delivery system is a synchronous approach to improve local drug penetration in neuromuscular diseases associated with neuronal damage, excruciating pain, and local inflammation. Chitosan, a semi-synthetic material, is obtained by partial deacetylation of chitin amines, resulting in copolymers of N-acetylglucosamine and N-glucosamine. Its use has been explored in various biomaterial and medical applications. Chitosan has emerged as a cost-effective, biocompatible, and biodegradable material with many desirable biological properties, improvement of homeostasis and antiviral potential. Chitosan was found to suppress pro-inflammatory cytokines and decreased peripheral nerve edema, the polycationic nature of chitosan allows it to absorb protons, which reduces inflammation and provides an analgesic effect.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

July 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

July 1, 2024

Last Update Submit

July 1, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Smartphone Addiction Scale-Short Version (SAS-SV)

    SAS-SV was psychometrically robust in measuring the severity of smartphone addiction

    four weeks

  • The visual analogue scale

    was utilized to evaluate pre- and post-treatment neck pain

    four weeks

  • Neck disability index

    assess how neck pain and other symptoms manifested during various functional activities. Ndi had been reported as a reliable (Cronbach's alpha: 0.89) and valid instrument to evaluate self-rated disability in patients with neck pain

    four weeks

Secondary Outcomes (1)

  • Cervical ROM

    four weeks

Study Arms (2)

study group

EXPERIMENTAL

Chitosan Phonophresis intervention

Drug: Chitosan PhonophresisOther: selected physical therapy exercise

control group

EXPERIMENTAL

the selected exercise program

Other: selected physical therapy exercise

Interventions

Chitosan Phonophresis, three times per week for four weeks.

study group

selected neck exercise and electrotherapy on cervical region

control groupstudy group

Eligibility Criteria

Age16 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Their age will be ranged from 16-18 years
  • body mass index will be 26.58 kg/m2.
  • used a smart phone for more than 1 year for at least 2 hours per day
  • complaining of neck pain after using a smart phone, addiction to smart phone in accordance with the smart phone addiction scale (SAS)

You may not qualify if:

  • any previous head and neck injuries or surgeries
  • any congenital abnormalities or symptomatic deformity in either the cervical or the lumbar spine
  • any uncorrected visual or auditory problems, dizziness, vertigo and headache
  • any systematic diseases, any addiction to alcohol, any additive drugs and sedatives within 48 hours previous to tests
  • body mass index of subjects over25 kg/m2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lama S Mahmoud

Al Jīzah, Select State, Egypt

RECRUITING

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Lama Saad El-Din ED Mahmoud

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lama Saad El-Din Mahmoud

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 9, 2024

Study Start

July 1, 2024

Primary Completion

September 30, 2024

Study Completion

October 15, 2024

Last Updated

July 9, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations