NCT05321030

Brief Summary

The purpose of this study is to investigate the association between smartphone addiction and back pain, function, and lumbar stabilizer cross-sectional area and thickness compared with non-addicted teenagers.

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
136

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

March 19, 2022

Last Update Submit

April 2, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Assessment of back function and disability

    Functional disability will be assessed by the Oswestry disability questionnaire, a functional scale assessing the impact of LBP on daily activities. It is a self-administered, 10-item questionnaire: the first section rates the intensity of pain and the others describe its disabling effect on typical daily activities. The score for each item ranges from 0 to 5, the score is calculated by the addition of the values assigned for each of the 10 individual questions

    at baseline only

  • Musculoskeletal assessment By Ultrasonography

    Ultrasonography will be used for measuring CSA and MT of LMM. Muscle thickness measurement by US.

    at baseline only

  • Core muscles strength

    Core stability will be measured using prone and supine bridging as bridging maneuvers seem to be practical, reliable, and valid methods of reflecting lumbar spine stabilization endurance capability. In prone bridge each subject will be in the prone position, supporting on the elbows. The elbows will be spaced shoulder-width apart, and the feet were set with a narrow base, but not touching. The subject then asked to raise the pelvis from the floor so that only the forearms and the toes were in contact with the floor. The shoulders, hips, and ankles were maintained in a straight line.

    at baseline only

Study Arms (2)

Smartphone addict

Smartphone non addict

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Using G-power version 3.1.9.7 for windows and regarding T-test study, alpha level of 0.05, confidence interval 95% and effect size of 0.25 (to detect small effects), two groups and six dependent variables, the total sample size was 136 subjects.

You may qualify if:

  • Age ranged from 18 years to 30 years.
  • BMI between 19.0-29.9 kg/m2.

You may not qualify if:

  • Previous history of spinal trauma or dysfunction. 2 - Any systemic disease that may affect spine such as ankylosing spondylitis and rheumatoid arthritis.
  • Cognitive or memory impairment in memory or cognitive function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic, Faculty of Physical Therapy, Cairo university

Dokki, 34518, Egypt

Location

MeSH Terms

Conditions

Internet Addiction Disorder

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Amira Hussin

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 19, 2022

First Posted

April 11, 2022

Study Start

April 1, 2022

Primary Completion

June 1, 2022

Study Completion

June 15, 2022

Last Updated

April 11, 2022

Record last verified: 2022-04

Locations