Pain, BackNCT03757520
Evaluation of Text Neck Syndrome and Hand Grip Force in Smart Phone Addiction Among Students of Jazan University
A study testing Pain Pressure Threshold and Hand Grip Force in people with Pain, Back and Neck Pain, run by Wafaa Mahmoud Amin at 1 site in Saudi Arabia.
Trial summary
This study will be conducted in the Department of physical therapy, College of Applied Medical Sciences,Jazan University, to investigate text neck syndrome and hand grip force in smart phone addiction among students of jazan university Read more about this study
- Who is it for?
- Ages 19 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Back, Neck Pain, Postural; Strain
- What is being tested?
- Pain Pressure Threshold and Hand Grip Force
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 11 Aug 2019to 18 Oct 2020
- Phase
- Interventional
- 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 19 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The participant will be right-handed.
- No abnormal findings confirmed through physical and neurological examination.
- No congenital abnormalities in either the cervical or the lumbar spine.
- No history of severe surgical procedures ( Park et al., 2015) .
Who cannot join
- History of a neurological disease.
- History of musculoskeletal injury of neck and lumbar region.
- Unstable medical condition.
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted in the Department of physical therapy, College of Applied Medical Sciences,Jazan University, to investigate text neck syndrome and hand grip force in smart phone addiction among students of jazan university
Read the detailed description
Four hundreds students with age 19 to 26 years old, and right dominant hand, will be recruited from the College of Applied Medical Sciences, Jazan University. Subjects will be randomly assigned to into a heavy user group (n=300; female and male students) and a control or regular use group (n=300; female and male students) according to their smartphone addiction proneness scale.
Baseline hydraulic hand dynamometer: (Fabrication Enterprises Incorporated, White Plains,New York, USA) is used to measure the hand grip strength and pinch strength.
Algometer Commander (JTech Medical Company) is used on the location of the trigger point to assess the amount of pressure the patient could sustain before the patient registered the pressure as being painful for upper fiber of trapezius muscle and sternocleidomastoid muscle
- Conditions
- Pain, Back, Neck Pain, Postural; Strain, Myofascial Pain Syndrome
- Being tested
- Pain Pressure Threshold, Hand Grip Force
- Medical subject headings
- Back Pain, Neck Pain, Sprains and Strains, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Pressure ThresholdDiagnostic test
Also called PPTs
The pain pressure thresholds (PPTs) will be measured using an pressure algometer commander over potential trigger points (TrPs) on the body for upper fiber of trapezius, and sternocleidomastoid muscle.
Hand Grip ForceDiagnostic test
For measuring the grip strength, the subjects will be asked to sit on a chair with their hip joint flexed at 90 degree, and shoulder joint in a neutral position.
The elbow is fixed at 90 degree flexion, forearm in a neutral position, and wrist at 0 to 15 degree radial deviation The test will be performed twice, and the higher value between the two measurements will be selected.
| Study group | Role | What they receive |
|---|---|---|
| Regular user group | Active comparator | Their number: 300; female and male students, will earn 39 points or less of Smartphone Addiction Proneness Scale. Pain Pressure Threshold and Hand Grip Force will Measured for them. Receives: Diagnostic Test: Pain Pressure Threshold; Diagnostic Test: Hand Grip Force |
| Heavy user group | Active comparator | Their number: 300; female and male students, will earn 40 points or more of Smartphone Addiction Proneness Scale. Pain Pressure Threshold and Hand Grip Force will Measured for them. Receives: Diagnostic Test: Pain Pressure Threshold; Diagnostic Test: Hand Grip Force |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain pressure threshold for upper fiber of trapezius muscle
Using Algometer to measure pain pressure for upper trapezius trigger point which lies in the more horizontal fibers of the upper trapezius on the back of the shoulder, about halfway between spine and the acromion on right and left side for 3 repetition for each
Measured: 3 minutes
Pain pressure threshold for sternocleidomastoid muscle
Using Algometer to measure pain pressure for sternocleidomastoid muscle on right and left side for 3 repetition for each. Measurement will includes three sites on each side:
- upper part of the sternal division of the muscle near to its insertion into the mastoid process. 2. he mid-part of the sternal division of the muscle. 3. lower end of this division near to its attachment to the sternum.
Measured: 9 minutes
Hand Grip Force
For measuring the grip strength, the subjects will be asked to sit on a chair with their hip joint flexed at 90 degree, and shoulder joint in a neutral position.
The elbow is fixed at 90 degree flexion, forearm in a neutral position, and wrist at 0 to 15 degree radial deviation.The test will be performed twice, and the higher value between the two measurements will be selected.
The subjects are allowed a rest time of more than 5 minutes after the first measurement to avoid examiner bias and to decrease physical stress
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start11 Aug 2019
- Primary completion16 Aug 2020
- Study completion18 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, BackStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- According two Smartphone Addiction Proneness Scale (SAPS) the subjects will be divided into two groups: Regular user group with SAPS score 39 or less. Heavy user group with SAPS score 40 or more. we have two variables to be assessed: 1. Pain pressure threshold for two muscles (upper fiber of trapezius and sternocleidomastoid muscle) 2. Hand grip force
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wafaa Mahmoud Amin
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Wafaa Mahmoud Amin, University of Jazan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757520
- Sponsor's protocol ID
- 0018827704
- Status last verified
- Nov 2020
- First submitted
- 23 Nov 2018
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: there is no plan
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Text Neck Syndrome and Hand Grip Force in Smart Phone Addiction Among Students of Jazan University
- ClinicalTrials.gov ID
- NCT03757520
- Acronym / sponsor ID
- 0018827704
- Conditions
- Pain, Back, Neck Pain, Postural; Strain, Myofascial Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Wafaa Mahmoud AminOther government
- Study start
- 11 Aug 2019 (actual)
- Primary completion
- 16 Aug 2020 (actual)
- Study completion
- 18 Oct 2020 (actual)
- First posted
- 29 Nov 2018 (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.
This study will be conducted in the Department of physical therapy, College of Applied Medical Sciences,Jazan University, to investigate text neck syndrome and hand grip force in smart phone addiction among students of jazan university
Detailed description
Four hundreds students with age 19 to 26 years old, and right dominant hand, will be recruited from the College of Applied Medical Sciences, Jazan University. Subjects will be randomly assigned to into a heavy user group (n=300; female and male students) and a control or regular use group (n=300; female and male students) according to their smartphone addiction proneness scale.
Baseline hydraulic hand dynamometer: (Fabrication Enterprises Incorporated, White Plains,New York, USA) is used to measure the hand grip strength and pinch strength.
Algometer Commander (JTech Medical Company) is used on the location of the trigger point to assess the amount of pressure the patient could sustain before the patient registered the pressure as being painful for upper fiber of trapezius muscle and sternocleidomastoid muscle
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- According two Smartphone Addiction Proneness Scale (SAPS) the subjects will be divided into two groups: Regular user group with SAPS score 39 or less. Heavy user group with SAPS score 40 or more. we have two variables to be assessed: 1. Pain pressure threshold for two muscles (upper fiber of trapezius and sternocleidomastoid muscle) 2. Hand grip force
| Arm | Type | Receives |
|---|---|---|
| Regular user group | Active comparator | Diagnostic Test: Pain Pressure Threshold, Diagnostic Test: Hand Grip ForceTheir number: 300; female and male students, will earn 39 points or less of Smartphone Addiction Proneness Scale. Pain Pressure Threshold and Hand Grip Force will Measured for them. |
| Heavy user group | Active comparator | Diagnostic Test: Pain Pressure Threshold, Diagnostic Test: Hand Grip ForceTheir number: 300; female and male students, will earn 40 points or more of Smartphone Addiction Proneness Scale. Pain Pressure Threshold and Hand Grip Force will Measured for them. |
Who may qualify
- Ages
- 19 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The participant will be right-handed.
- No abnormal findings confirmed through physical and neurological examination.
- No congenital abnormalities in either the cervical or the lumbar spine.
- No history of severe surgical procedures ( Park et al., 2015) .
Key exclusion criteria (3 listed)
- History of a neurological disease.
- History of musculoskeletal injury of neck and lumbar region.
- Unstable medical condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Pressure ThresholdAlso: PPTsThe pain pressure thresholds (PPTs) will be measured using an pressure algometer commander over potential trigger points (TrPs) on the body for upper fiber of trapezius, and sternocleidomastoid muscle. | Diagnostic test | Heavy user group, Regular user group |
| Hand Grip ForceFor measuring the grip strength, the subjects will be asked to sit on a chair with their hip joint flexed at 90 degree, and shoulder joint in a neutral position. The elbow is fixed at 90 degree flexion, forearm in a neutral position, and wrist at 0 to 15 degree radial deviation The test will be performed twice, and the higher value between the two measurements will be selected. | Diagnostic test | Heavy user group, Regular user group |
Primary outcome
Pain pressure threshold for upper fiber of trapezius muscle
Time frame: 3 minutes
Using Algometer to measure pain pressure for upper trapezius trigger point which lies in the more horizontal fibers of the upper trapezius on the back of the shoulder, about halfway between spine and the acromion on right and left side for 3 repetition for each
Pain pressure threshold for sternocleidomastoid muscle
Time frame: 9 minutes
Using Algometer to measure pain pressure for sternocleidomastoid muscle on right and left side for 3 repetition for each. Measurement will includes three sites on each side: 1. upper part of the sternal division of the muscle near to its insertion into the mastoid process. 2. he mid-part of the sternal division of the muscle. 3. lower end of this division near to its attachment to the sternum.
Hand Grip Force
Time frame: 15 minutes
For measuring the grip strength, the subjects will be asked to sit on a chair with their hip joint flexed at 90 degree, and shoulder joint in a neutral position. The elbow is fixed at 90 degree flexion, forearm in a neutral position, and wrist at 0 to 15 degree radial deviation.The test will be performed twice, and the higher value between the two measurements will be selected. The subjects are allowed a rest time of more than 5 minutes after the first measurement to avoid examiner bias and to decrease physical stress
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Individual participant dataSharing planned: Undecided. there is no plan
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Pressure Threshold and Hand Grip Force in people with Pain, Back and Neck Pain, run by Wafaa Mahmoud Amin at 1 site in Saudi Arabia.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 10 Nov 2020. 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain pressure threshold for upper fiber of trapezius muscle (time frame: 3 minutes). 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 10 Nov 2020.