Back DisorderNCT05321030
Correlation Between Smartphone Addiction and Back Dysfunction and Core Muscle Morphology and Performance in Asymptomatic Young Adults
An observational study of Back Disorder and Smartphone Addiction, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Back Disorder, Smartphone Addiction
- How many people
- 136 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 15 Jun 2022
- 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 18 to 30 years
- All sexes
- Adult
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.
Who may be able to join
- Age ranged from 18 years to 30 years.
- BMI between 19.0-29.9 kg/m2.
Who cannot join
- 1- Previous history of spinal trauma or dysfunction. 2 - Any systemic disease that may affect spine such as ankylosing spondylitis and rheumatoid arthritis.
- 3 - Cognitive or memory impairment in memory or cognitive function.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic, Faculty of Physical Therapy, Cairo university
Dokki, 34518
About this study
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.
Read the detailed description
Smartphone prolonged use has been suggested as a risk factor for psychological, visual, and musculoskeletal dysfunctions. The musculoskeletal dysfunction may be related to direct contact use with smartphones as in thumb, elbow, and neck pain. Moreover, indirect long use of smartphones may affect thoracic, lumbar, and lower limbs.
COVID-19 pandemic occurred in a time of outstanding scientific progress and global digitalization. Therefore, smartphone usage became a must for human connection, learning, and entertainment, providing psychological and social support. In the meantime, it was observed a significant increase in overuse and addiction, especially in young and teenage females. The addiction is associated with more musculoskeletal abnormalities when compared to non-addict users. Several studies found an association between smartphone usage and back pain, concomitant with a reduction in thoracic extensors activity. This back pain may affect their quality of life and work-related productivity. However, the relationship between back dysfunction and smartphone addiction is still unclear. A few attempts were done to elucidate this relationship. Yet if proven correct, then preventive measures such as recommendations and precautions regarding smartphone use could be distributed to users by the manufacturers. Furthermore, engineering solutions are needed to optimally design smartphones to alter their weight and sizes to minimize potential adverse effects.
- Conditions
- Back Disorder, Smartphone Addiction
- Medical subject headings
- Internet Addiction Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone addict | Not described | |
| Smartphone non addict | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at baseline only
Musculoskeletal assessment By Ultrasonography
Ultrasonography will be used for measuring CSA and MT of LMM. Muscle thickness measurement by US.
Measured: 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.
Measured: at baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion15 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back DisorderStudies 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
- Cross-sectional
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mahmoud Hussin, Cairo University
- Investigators
- Amira Hussin, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321030
- Sponsor's protocol ID
- Asmaa_PhD_2022
- Status last verified
- Apr 2022
- First submitted
- 19 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Smartphone Addiction and Back Dysfunction and Core Muscle Morphology and Performance in Asymptomatic Young Adults
- ClinicalTrials.gov ID
- NCT05321030
- Acronym / sponsor ID
- Asmaa_PhD_2022
- Conditions
- Back Disorder, Smartphone Addiction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 11 Apr 2022 (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.
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.
Detailed description
Smartphone prolonged use has been suggested as a risk factor for psychological, visual, and musculoskeletal dysfunctions. The musculoskeletal dysfunction may be related to direct contact use with smartphones as in thumb, elbow, and neck pain. Moreover, indirect long use of smartphones may affect thoracic, lumbar, and lower limbs.
COVID-19 pandemic occurred in a time of outstanding scientific progress and global digitalization. Therefore, smartphone usage became a must for human connection, learning, and entertainment, providing psychological and social support. In the meantime, it was observed a significant increase in overuse and addiction, especially in young and teenage females. The addiction is associated with more musculoskeletal abnormalities when compared to non-addict users. Several studies found an association between smartphone usage and back pain, concomitant with a reduction in thoracic extensors activity. This back pain may affect their quality of life and work-related productivity. However, the relationship between back dysfunction and smartphone addiction is still unclear. A few attempts were done to elucidate this relationship. Yet if proven correct, then preventive measures such as recommendations and precautions regarding smartphone use could be distributed to users by the manufacturers. Furthermore, engineering solutions are needed to optimally design smartphones to alter their weight and sizes to minimize potential adverse effects.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone addict | – | – |
| Smartphone non addict | – | – |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Age ranged from 18 years to 30 years.
- BMI between 19.0-29.9 kg/m2.
Key exclusion criteria (2 listed)
- 1- Previous history of spinal trauma or dysfunction. 2 - Any systemic disease that may affect spine such as ankylosing spondylitis and rheumatoid arthritis.
- 3 - Cognitive or memory impairment in memory or cognitive function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of back function and disability
Time frame: at baseline only
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
Musculoskeletal assessment By Ultrasonography
Time frame: at baseline only
Ultrasonography will be used for measuring CSA and MT of LMM. Muscle thickness measurement by US.
Core muscles strength
Time frame: at baseline only
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
Amira Hussin principal investigator
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 Back Disorder and Smartphone Addiction, 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 11 Apr 2022. 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 Amira Hussin (00201016771833, am7892216@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of back function and disability (time frame: at baseline only). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2022.