Neck PainNCT03745469
The Effect of Smartphone Use Duration in Patients With Chronic Mechanical Neck Pain.
An observational study of Neck Pain and Cervical Pain, run by Aliaa Rehan Youssef at 2 sites in Egypt.
Trial summary
PURPOSE: The purpose of this study is to investigate the effects of smartphone usage duration on neck pain and sense of position as well as Deep Cervical Flexor (DCF) fatigue in young and middle aged patients with chronic mechanical neck pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Neck Pain, Cervical Pain
- What is being tested?
- Smartphone
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Nov 2018to 31 Jan 2019
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients will a confirmed diagnosis of chronic mechanical neck pain for over 3 months.
Who may be able to join
- Adult female patients with an age ranging from 18 to 60 years old.
- Referred with a diagnosis of chronic mechanical neck pain for more than 3 months.
- Patients should have at least a one year experience in using touch-screen smartphone.
- Have a neck impairment of more than 8% on the neck disability index (NDI).
Who cannot join
- Any history of upper extremity injury or surgery within the past year
- Visual problems, dizziness and vertigo
- Any deformity in the upper extremities or spine
- Previous history of spinal surgery.
- Neurological or systemic disorders that interfere with balance and sensation
- Low back pain or deformity.
- Patients with any red flags such as malignancy, infection, inflammation, myelopathy.
- If patient having any physical difficulties interfering with the use of smartphone while sitting and standing.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
The outpatient clinic of the Faculty of Physical Therapy, Cairo University
Cairo
The outpatient Clinic, kasr Al-Aini Hospital
Cairo
About this study
Official title: Effects of Smartphone Usage Duration on Neck Dysfunction in Young Versus Middle Aged Patients With Chronic Mechanical Neck Pain
PURPOSE: The purpose of this study is to investigate the effects of smartphone usage duration on neck pain and sense of position as well as Deep Cervical Flexor (DCF) fatigue in young and middle aged patients with chronic mechanical neck pain.
BACKGROUND: Neck pain is one of most common causes of musculoskeletal disorders with a prevalence up to 86.8 %. It may interfere with the ability to perform normal activities of daily living (ADL). Patients with neck pain may present with reduced Rang of Motion (ROM) and diminished cervical position sense.
Read more
There are many risk factors that have been associated with neck pain including physiological factors such as age or pathomechanical factors such as increased physical demand on the spine. Smartphone use has been proposed as a risk factor for the development of neck pain in young adults due to sustaining a prolonged static posture or repeating particular neck movements for long period. The adverse effects of smartphone increases as the duration of the use increases. Aging is associated with increased cervical reposition error and reduced DCF muscle endurance, yet it is not clear how older adults will respond to prolonged use of smartphone.
HYPOTHESES: Increased duration of smartphone use will
- increase neck pain in middle aged compared to young adult patients with chronic mechanical.
- decrease cervical position sense in middle aged compared to young adult patients with chronic mechanical neck pain.
- increase DCF fatigue in middle aged compared to young adult patients with chronic mechanical neck pain.
RESEARCH QUESTION: Would increased duration of smartphone usage accentuate neck pain, cervical reposition error and DCF fatigue in middle aged compared to young adults with chronic mechanical neck pain?
Read the detailed description
Patients with chronic mechanical neck pain will be instructed to use a standard smartphone for web browsing, either for 10 or 30 minutes, while seated on a standard chair at two separate sessions. Task duration will be tested by a random order generated by the Excel software.
The outcome measures for this study will be neck pain, DCF fatigue and neck reposition error. All measures will be assessed prior to and immediately after performing the required task in each session by a single trained assessor.
Neck pain will be assessed using the visual analogue scale (VAS), proprioception acuity will be quantified by measuring the repositioning error angle using Cervical Range of Motion instrument (CROM) and DCF endurance will be quantified using the neck stabilizer pressure biofeedback device.
- Conditions
- Neck Pain, Cervical Pain
- Being tested
- Smartphone
- Keywords
- Smartphone, Age, proprioception, Deep cervical fatigue, neck pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartphoneDevice
Also called Smart phone, Cell phone, Mobile Phone
A standard smartphone will be used for browsing the internet for two different durations (10 and 30 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Young-age group | Patient between the age of 18 and 30 years old, with a confirmed diagnosis of chronic mechanical neck pain Receives: Device: Smartphone | |
| Middle-age group | Patients between 30 and 60 years old, with a confirmed diagnosis of chronic mechanical neck pain. Receives: Device: Smartphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current neck pain severity
Pain will be measured using the Visual Analogue Scale (VAS) which is a valid and reliable pain measurement tool.
Each participant will be asked to put a mark on a 10-cm horizontal line that is marked with 'zero' at one end to indicate no pain and marked with'10' at the other end to indicate maximum pain.This ill be done at two separate session, before and immediately after using the smartphone for the specified period.
Measured: 1 week
Secondary outcomes (2)
DCF endurance
The endurance of DCF muscles will be assessed using the Neck stabilizer pressure biofeedback. This ill be done at two separate session, before and immediately after using the smartphone for the specified period.
Measured: 1 week
Neck proprioception
repositioning error for neck flexion, extension and rotation will be measured using the CROM. Error will be calculated as absolute angle of error. This ill be done at two separate session, before and immediately after using the smartphone for the specified period.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start20 Nov 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (100)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aliaa Rehan Youssef
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aliaa Rehan Youssef, Cairo University
- Investigators
- Aliaa Rehan Youssef, PhD, Principal investigator, Cairo University, Faculty of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745469
- Sponsor's protocol ID
- Asmaa
- Status last verified
- Feb 2019
- First submitted
- 15 Nov 2018
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Journal publications and conferences
Publications
Adamo DE, Martin BJ, Brown SH. Age-related differences in upper limb proprioceptive acuity. Percept Mot Skills. 2007 Jun;104(3 Pt 2):1297-309. doi: 10.2466/pms.104.4.1297-1309.
PubMed 17879664AlAbdulwahab SS, Kachanathu SJ, AlMotairi MS. Smartphone use addiction can cause neck disability. Musculoskeletal Care. 2017 Mar;15(1):10-12. doi: 10.1002/msc.1170. Epub 2017 Jan 19. No abstract available.
PubMed 28105706Alahmari KA, Reddy RS, Silvian PS, Ahmad I, Kakaraparthi VN, Alam MM. Association of age on cervical joint position error. J Adv Res. 2017 May;8(3):201-207. doi: 10.1016/j.jare.2017.01.001. Epub 2017 Jan 9.
PubMed 28203459Almhdawi KA, Mathiowetz V, Al-Hourani Z, Khader Y, Kanaan SF, Alhasan M. Musculoskeletal pain symptoms among allied health professions' students: Prevalence rates and associated factors. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1291-1301. doi: 10.3233/BMR-169669.
PubMed 28946521AlZarea, B. K., & Patil, S. R. (2015). Mobile Phone Head and Neck Pain Syndrome : Proposal of a New Entity. Headache, 14(5), 63-3.
Ariens GA, Bongers PM, Douwes M, Miedema MC, Hoogendoorn WE, van der Wal G, Bouter LM, van Mechelen W. Are neck flexion, neck rotation, and sitting at work risk factors for neck pain? Results of a prospective cohort study. Occup Environ Med. 2001 Mar;58(3):200-7. doi: 10.1136/oem.58.3.200.
PubMed 11171934Armstrong BS, McNair PJ, Williams M. Head and neck position sense in whiplash patients and healthy individuals and the effect of the cranio-cervical flexion action. Clin Biomech (Bristol). 2005 Aug;20(7):675-84. doi: 10.1016/j.clinbiomech.2005.03.009.
PubMed 15963617Arslan, Ahmet; Tutgun, A. (2013). Examination of cell phone usage habits and purposes of education faculty students. International Journal of Human Sciences, 10(1), 182-201.
Audette I, Dumas JP, Cote JN, De Serres SJ. Validity and between-day reliability of the cervical range of motion (CROM) device. J Orthop Sports Phys Ther. 2010 May;40(5):318-23. doi: 10.2519/jospt.2010.3180.
PubMed 20436238Auffinger B, Lam S, Shen J, Thaci B, Roitberg BZ. Usefulness of minimum clinically important difference for assessing patients with subaxial degenerative cervical spine disease: statistical versus substantial clinical benefit. Acta Neurochir (Wien). 2013 Dec;155(12):2345-54; discussion 2355. doi: 10.1007/s00701-013-1909-4. Epub 2013 Oct 18.
PubMed 24136679Bababekova Y, Rosenfield M, Hue JE, Huang RR. Font size and viewing distance of handheld smart phones. Optom Vis Sci. 2011 Jul;88(7):795-7. doi: 10.1097/OPX.0b013e3182198792.
PubMed 21499163Binder A. The diagnosis and treatment of nonspecific neck pain and whiplash. Eura Medicophys. 2007 Mar;43(1):79-89.
PubMed 17369782Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.
PubMed 28666405Blatter, B. M., & Bongers, P. M. (2002). Duration of computer use and mouse use in relation to musculoskeletal disorders of neck or upper limb. International Journal of Industrial Ergonomics, 30(4-5), 295-306.
Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93.
PubMed 18467932
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Smartphone Usage Duration on Neck Dysfunction in Young Versus Middle Aged Patients With Chronic Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT03745469
- Acronym / sponsor ID
- Asmaa
- Conditions
- Neck Pain, Cervical Pain
- Keywords
- Smartphone, Age, proprioception, Deep cervical fatigue, neck pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Aliaa Rehan YoussefUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 19 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.
PURPOSE: The purpose of this study is to investigate the effects of smartphone usage duration on neck pain and sense of position as well as Deep Cervical Flexor (DCF) fatigue in young and middle aged patients with chronic mechanical neck pain.
BACKGROUND: Neck pain is one of most common causes of musculoskeletal disorders with a prevalence up to 86.8 %. It may interfere with the ability to perform normal activities of daily living (ADL). Patients with neck pain may present with reduced Rang of Motion (ROM) and diminished cervical position sense.
There are many risk factors that have been associated with neck pain including physiological factors such as age or pathomechanical factors such as increased physical demand on the spine. Smartphone use has been proposed as a risk factor for the development of neck pain in young adults due to sustaining a prolonged static posture or repeating particular neck movements for long period. The adverse effects of smartphone increases as the duration of the use increases. Aging is associated with increased cervical reposition error and reduced DCF muscle endurance, yet it is not clear how older adults will respond to prolonged use of smartphone.
HYPOTHESES: Increased duration of smartphone use will
- increase neck pain in middle aged compared to young adult patients with chronic mechanical.
- decrease cervical position sense in middle aged compared to young adult patients with chronic mechanical neck pain.
- increase DCF fatigue in middle aged compared to young adult patients with chronic mechanical neck pain.
RESEARCH QUESTION: Would increased duration of smartphone usage accentuate neck pain, cervical reposition error and DCF fatigue in middle aged compared to young adults with chronic mechanical neck pain?
Detailed description
Patients with chronic mechanical neck pain will be instructed to use a standard smartphone for web browsing, either for 10 or 30 minutes, while seated on a standard chair at two separate sessions. Task duration will be tested by a random order generated by the Excel software.
The outcome measures for this study will be neck pain, DCF fatigue and neck reposition error. All measures will be assessed prior to and immediately after performing the required task in each session by a single trained assessor.
Neck pain will be assessed using the visual analogue scale (VAS), proprioception acuity will be quantified by measuring the repositioning error angle using Cervical Range of Motion instrument (CROM) and DCF endurance will be quantified using the neck stabilizer pressure biofeedback device.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young-age group | – | Device: SmartphonePatient between the age of 18 and 30 years old, with a confirmed diagnosis of chronic mechanical neck pain |
| Middle-age group | – | Device: SmartphonePatients between 30 and 60 years old, with a confirmed diagnosis of chronic mechanical neck pain. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients will a confirmed diagnosis of chronic mechanical neck pain for over 3 months.
Key inclusion criteria (4 listed)
- Adult female patients with an age ranging from 18 to 60 years old.
- Referred with a diagnosis of chronic mechanical neck pain for more than 3 months.
- Patients should have at least a one year experience in using touch-screen smartphone.
- Have a neck impairment of more than 8% on the neck disability index (NDI).
Key exclusion criteria (8 listed)
- Any history of upper extremity injury or surgery within the past year
- Visual problems, dizziness and vertigo
- Any deformity in the upper extremities or spine
- Previous history of spinal surgery.
- Neurological or systemic disorders that interfere with balance and sensation
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 |
|---|---|---|
| SmartphoneAlso: Smart phone, Cell phone, Mobile PhoneA standard smartphone will be used for browsing the internet for two different durations (10 and 30 minutes) | Device | Middle-age group, Young-age group |
Primary outcome
Current neck pain severity
Time frame: 1 week
Pain will be measured using the Visual Analogue Scale (VAS) which is a valid and reliable pain measurement tool. Each participant will be asked to put a mark on a 10-cm horizontal line that is marked with 'zero' at one end to indicate no pain and marked with'10' at the other end to indicate maximum pain.This ill be done at two separate session, before and immediately after using the smartphone for the specified period.
2 secondary outcomes
DCF endurance
Time frame: 1 week
Neck proprioception
Time frame: 1 week
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 5 Feb 2019.
- Background: PubMed 17879664Adamo DE, Martin BJ, Brown SH. Age-related differences in upper limb proprioceptive acuity. Percept Mot Skills. 2007 Jun;104(3 Pt 2):1297-309. doi: 10.2466/pms.104.4.1297-1309.
- Background: PubMed 28105706AlAbdulwahab SS, Kachanathu SJ, AlMotairi MS. Smartphone use addiction can cause neck disability. Musculoskeletal Care. 2017 Mar;15(1):10-12. doi: 10.1002/msc.1170. Epub 2017 Jan 19. No abstract available.
- Background: PubMed 28203459Alahmari KA, Reddy RS, Silvian PS, Ahmad I, Kakaraparthi VN, Alam MM. Association of age on cervical joint position error. J Adv Res. 2017 May;8(3):201-207. doi: 10.1016/j.jare.2017.01.001. Epub 2017 Jan 9.
- Background: PubMed 28946521Almhdawi KA, Mathiowetz V, Al-Hourani Z, Khader Y, Kanaan SF, Alhasan M. Musculoskeletal pain symptoms among allied health professions' students: Prevalence rates and associated factors. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1291-1301. doi: 10.3233/BMR-169669.
- BackgroundAlZarea, B. K., & Patil, S. R. (2015). Mobile Phone Head and Neck Pain Syndrome : Proposal of a New Entity. Headache, 14(5), 63-3.
- Background: PubMed 11171934Ariens GA, Bongers PM, Douwes M, Miedema MC, Hoogendoorn WE, van der Wal G, Bouter LM, van Mechelen W. Are neck flexion, neck rotation, and sitting at work risk factors for neck pain? Results of a prospective cohort study. Occup Environ Med. 2001 Mar;58(3):200-7. doi: 10.1136/oem.58.3.200.
- Background: PubMed 15963617Armstrong BS, McNair PJ, Williams M. Head and neck position sense in whiplash patients and healthy individuals and the effect of the cranio-cervical flexion action. Clin Biomech (Bristol). 2005 Aug;20(7):675-84. doi: 10.1016/j.clinbiomech.2005.03.009.
- BackgroundArslan, Ahmet; Tutgun, A. (2013). Examination of cell phone usage habits and purposes of education faculty students. International Journal of Human Sciences, 10(1), 182-201.
- Background: PubMed 20436238Audette I, Dumas JP, Cote JN, De Serres SJ. Validity and between-day reliability of the cervical range of motion (CROM) device. J Orthop Sports Phys Ther. 2010 May;40(5):318-23. doi: 10.2519/jospt.2010.3180.
- Background: PubMed 24136679Auffinger B, Lam S, Shen J, Thaci B, Roitberg BZ. Usefulness of minimum clinically important difference for assessing patients with subaxial degenerative cervical spine disease: statistical versus substantial clinical benefit. Acta Neurochir (Wien). 2013 Dec;155(12):2345-54; discussion 2355. doi: 10.1007/s00701-013-1909-4. Epub 2013 Oct 18.
- Background: PubMed 21499163Bababekova Y, Rosenfield M, Hue JE, Huang RR. Font size and viewing distance of handheld smart phones. Optom Vis Sci. 2011 Jul;88(7):795-7. doi: 10.1097/OPX.0b013e3182198792.
- Background: PubMed 17369782Binder A. The diagnosis and treatment of nonspecific neck pain and whiplash. Eura Medicophys. 2007 Mar;43(1):79-89.
- Individual participant dataSharing planned: Undecided. Journal publications and conferences
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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.
Aliaa Rehan Youssef, PhD principal investigator
Cairo University, Faculty of Physical Therapy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain and Cervical Pain, run by Aliaa Rehan Youssef at 2 sites 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 4 inclusion and 8 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Current neck pain severity (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03745469, which also lists 100 linked publications.
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 5 Feb 2019.