Mechanical Low Back PainNCT03517410
Association Between the Duration of Smart Phone Use and Back Dysfunction in Patients With Low Back Pain
An observational study of Mechanical Low Back Pain, run by Aliaa Rehan Youssef at 1 site in Egypt.
Trial summary
This study investigates the association between the duration of smart phone use and back pain and proprioception deficits in patients with chronic mechanical low back pain (CLBP). It is hypothesized that increased duration of smart phone use will be associated with 1. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- Smart phone use
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2018to 31 Dec 2018
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Seventy male and female adults will be recruited from out patient clinic of the faculties of Physical therapy and medicine, Cairo University. Further, physical therapy students who are diagnosed with CLBP will be recruited via advertising on social media.
Who may be able to join
- Egyptian adult patients with mechanical CLBP Back pain duration is greater than 3 months Age ranging from 18 years to 45
Who cannot join
- Patients with any systemic disease that may affect spine function.
- Patients with previous history of spine trauma or dysfunction other than mechanical LBP.
- Lumbosacral nerve root entrapment.
- Patients with memory loss or impaired cognitive function
- patients who report back pain associated with sitting position
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between the Duration of Smart Phone Use and Back Dysfunction in Patients With Chronic Mechanical Low Back Pain
This study investigates the association between the duration of smart phone use and back pain and proprioception deficits in patients with chronic mechanical low back pain (CLBP).
It is hypothesized that increased duration of smart phone use will be associated with
- Increased back pain as measured by the Visual Analogue Scale (VAS)
- Reduced proprioception acuity as indicated by increased angle of error of back repositioning as measured by isokinetic dynamometer.
Read the detailed description
After patient screening against inclusion and exclusion criteria, eligible patients will be informed about the aim of the study and all testing procedures. Then, they will be asked to participate in the study, if agreed an informed consent will be signed . Basic demographic information as well as questions regarding the average daily smart phone use will be collected .
Patient will be tested in two separate sessions. During each session, the participant will be given a standardized phone and will be asked to play a standardized game "subway surfers " from a standardized sitting position for 10 or 30 minutes.
Pain and back repositioning error will be measured before and after the smart phone use. Pain will be measured first, then repositioning error.
Pain measurement:
Each participant will be instructed to rate the current level of pain by placing a mark across the horizontal VAS line. The distance in millimeters from the lower limit will be measured using a ruler.
Proprioception acuity:
Biodex isokinetic system preparation:
First, the system will be calibrated according to the manufacturer guidelines. For initialization of the Biodex system, the device, computer and dynamometer power will be switched on and all device attachments will be removed. Then, the start key in the control panel will be pressed. Few seconds will be allowed for the dynamometer shaft to rotate freely until the system displays a message that it is initializing the dynamometer. Once the initialization procedure is completed, the start key will be pressed again as indicated by the system status window. The personal data of each subject will be entered into the computer.
Repositioning error measurement:
Each participant will then be seated on the Biodex chair with his or her low back fitted backwards against the lumbar pad. Both knees will be fixed in place using two anterior curved leg pads. Legs will be kept relaxed vertically with both feet off the ground. The upper trunk will be fastened to the back of the chair using a belt. Both thighs will be fastened to the chair using straps while forearms will be kept crossed over the chest. The seat will be adjusted to allow the axis of rotation of the dynamometer to be at the level of L5/S1 disc space. Participants will be instructed to close their eyes during test performance. The limits of available range of motion (ROM) will determined for each participant by starting at the 0° position (neutral sitting with hips flexed 90°) and then instructing the participant to flex his or her trunk as much as possible to determine the available ROM in flexion and examine his or her ability to reach the target position for the isokinetic test (30° of lumbar flexion). The dynamometer will be locked in the 0° position to provide a fixed starting position for all participants during all trials The chosen protocol allows the participants to perform 1 familiarization trial followed by 1 actual test; this step will be repeated 3 times so that there will be 3 familiarization trials and 3 actual testing procedures. The average of the 3 actual testing results will be retrieved from the isokinetic device software. During the familiarization trial and after covering the eyes, participant will be instructed to flex his or her trunk until it is stopped by the machine at 30° of flexion. This position will be held for 5 seconds. The patients will be instructed to remember this position in order to reproduce it as precisely as possible during the subsequent actual test procedure. During the actual test procedure, the tested participants will press a hold button when they assume the target position to allow the device to record and save the reached angle. During the data collection process, no visual (eyes will be closed) or verbal feedback will be provided for the participants.
The results of the test will be recorded and printed by the isokinetic machine. It will include the value of error of every trial and the average error of the 3 trials.
- Conditions
- Mechanical Low Back Pain
- Being tested
- Smart phone use
- Keywords
- Mechanical Low Back Pain, Smart phone, Low Back Pain, Chronic Mechanical Low Back Pain, CLBP
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart phone useOther
Patients will be asked to use the smart phone while seated for either: (1) 10 minutes or (2) 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Smart phone Use Experimental group | Patients with CLBP Receives: Other: Smart phone use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Current pain intensity will be measured using the Visual Analogue Scale (VAS). This scale is a 100 mm line drawn on a piece of paper. The line is labeled 0 at one end (indicating no pain) and 10 at the other end (indicating excruciating pain). A change of minimally 20 mm on VAS is considered a minimal detectable change.
Measured: same day
Secondary outcomes (1)
Back repositioning error in flexion direction
Back repositioning error flexion as measured using Biodex isokinetic system 3 at 30 degree angle flexion
Measured: Same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start15 May 2018
- Primary completion1 Nov 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Mechanical Low Back 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
- 62 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 UniversityDina Othman Shokri, PhD, Study director, Faculty of Physical Therapy, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517410
- Sponsor's protocol ID
- MWahba
- Status last verified
- May 2019
- First submitted
- 25 Apr 2018
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alhalabi MS, Alhaleeb H, Madani S. Risk factors associated with chronic low back pain in Syria. Avicenna J Med. 2015 Oct-Dec;5(4):110-6. doi: 10.4103/2231-0770.165123.
PubMed 26629465Ali M, Asim M, Danish SH, Ahmad F, Iqbal A, Hasan SD. Frequency of De Quervain's tenosynovitis and its association with SMS texting. Muscles Ligaments Tendons J. 2014 May 8;4(1):74-8. eCollection 2014 Jan.
PubMed 24932451Atlas SJ, Deyo RA. Evaluating and managing acute low back pain in the primary care setting. J Gen Intern Med. 2001 Feb;16(2):120-31. doi: 10.1111/j.1525-1497.2001.91141.x.
PubMed 11251764Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
PubMed 21982256Balakrishnan, R., Chinnavan, E., & Feii, T. (2016). An extensive usage of hand held devices will lead to musculoskeletal disorder of upper extremity among student in AMU : A survey method. International Journal of Physical Education, Sport and Health, 3(2), 368-372.
Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.
PubMed 11733293Chany AM, Marras WS, Burr DL. The effect of phone design on upper extremity discomfort and muscle fatigue. Hum Factors. 2007 Aug;49(4):602-18. doi: 10.1518/001872007X215683.
PubMed 17702212Borenstein DG. Chronic low back pain. Rheum Dis Clin North Am. 1996 Aug;22(3):439-56. doi: 10.1016/s0889-857x(05)70281-7.
PubMed 8844907Chiang HY, Liu CH. Exploration of the associations of touch-screen tablet computer usage and musculoskeletal discomfort. Work. 2016 Mar 10;53(4):917-25. doi: 10.3233/WOR-162274.
PubMed 26967038Deyo RA. Early diagnostic evaluation of low back pain. J Gen Intern Med. 1986 Sep-Oct;1(5):328-38. doi: 10.1007/BF02596214. No abstract available.
PubMed 2945917Downie WW, Leatham PA, Rhind VM, Wright V, Branco JA, Anderson JA. Studies with pain rating scales. Ann Rheum Dis. 1978 Aug;37(4):378-81. doi: 10.1136/ard.37.4.378.
PubMed 686873Drouin JM, Valovich-mcLeod TC, Shultz SJ, Gansneder BM, Perrin DH. Reliability and validity of the Biodex system 3 pro isokinetic dynamometer velocity, torque and position measurements. Eur J Appl Physiol. 2004 Jan;91(1):22-9. doi: 10.1007/s00421-003-0933-0. Epub 2003 Sep 24.
PubMed 14508689Garcia-Vaquero MP, Barbado D, Juan-Recio C, Lopez-Valenciano A, Vera-Garcia FJ. Isokinetic trunk flexion-extension protocol to assess trunk muscle strength and endurance: Reliability, learning effect, and sex differences. J Sport Health Sci. 2020 Dec;9(6):692-701. doi: 10.1016/j.jshs.2016.08.011. Epub 2016 Nov 14.
PubMed 33308821Georgy EE. Lumbar repositioning accuracy as a measure of proprioception in patients with back dysfunction and healthy controls. Asian Spine J. 2011 Dec;5(4):201-7. doi: 10.4184/asj.2011.5.4.201. Epub 2011 Nov 28.
PubMed 22164313Gustafsson E, Johnson PW, Lindegard A, Hagberg M. Technique, muscle activity and kinematic differences in young adults texting on mobile phones. Ergonomics. 2011 May;54(5):477-87. doi: 10.1080/00140139.2011.568634.
PubMed 21547792
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between the Duration of Smart Phone Use and Back Dysfunction in Patients With Chronic Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT03517410
- Acronym / sponsor ID
- MWahba
- Conditions
- Mechanical Low Back Pain
- Keywords
- Mechanical Low Back Pain, Smart phone, Low Back Pain, Chronic Mechanical Low Back Pain, CLBP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Aliaa Rehan YoussefUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 7 May 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 investigates the association between the duration of smart phone use and back pain and proprioception deficits in patients with chronic mechanical low back pain (CLBP).
It is hypothesized that increased duration of smart phone use will be associated with
- Increased back pain as measured by the Visual Analogue Scale (VAS)
- Reduced proprioception acuity as indicated by increased angle of error of back repositioning as measured by isokinetic dynamometer.
Detailed description
After patient screening against inclusion and exclusion criteria, eligible patients will be informed about the aim of the study and all testing procedures. Then, they will be asked to participate in the study, if agreed an informed consent will be signed . Basic demographic information as well as questions regarding the average daily smart phone use will be collected .
Patient will be tested in two separate sessions. During each session, the participant will be given a standardized phone and will be asked to play a standardized game "subway surfers " from a standardized sitting position for 10 or 30 minutes.
Pain and back repositioning error will be measured before and after the smart phone use. Pain will be measured first, then repositioning error.
Pain measurement:
Each participant will be instructed to rate the current level of pain by placing a mark across the horizontal VAS line. The distance in millimeters from the lower limit will be measured using a ruler.
Proprioception acuity:
Biodex isokinetic system preparation:
First, the system will be calibrated according to the manufacturer guidelines. For initialization of the Biodex system, the device, computer and dynamometer power will be switched on and all device attachments will be removed. Then, the start key in the control panel will be pressed. Few seconds will be allowed for the dynamometer shaft to rotate freely until the system displays a message that it is initializing the dynamometer. Once the initialization procedure is completed, the start key will be pressed again as indicated by the system status window. The personal data of each subject will be entered into the computer.
Repositioning error measurement:
Each participant will then be seated on the Biodex chair with his or her low back fitted backwards against the lumbar pad. Both knees will be fixed in place using two anterior curved leg pads. Legs will be kept relaxed vertically with both feet off the ground. The upper trunk will be fastened to the back of the chair using a belt. Both thighs will be fastened to the chair using straps while forearms will be kept crossed over the chest. The seat will be adjusted to allow the axis of rotation of the dynamometer to be at the level of L5/S1 disc space. Participants will be instructed to close their eyes during test performance. The limits of available range of motion (ROM) will determined for each participant by starting at the 0° position (neutral sitting with hips flexed 90°) and then instructing the participant to flex his or her trunk as much as possible to determine the available ROM in flexion and examine his or her ability to reach the target position for the isokinetic test (30° of lumbar flexion). The dynamometer will be locked in the 0° position to provide a fixed starting position for all participants during all trials The chosen protocol allows the participants to perform 1 familiarization trial followed by 1 actual test; this step will be repeated 3 times so that there will be 3 familiarization trials and 3 actual testing procedures. The average of the 3 actual testing results will be retrieved from the isokinetic device software. During the familiarization trial and after covering the eyes, participant will be instructed to flex his or her trunk until it is stopped by the machine at 30° of flexion. This position will be held for 5 seconds. The patients will be instructed to remember this position in order to reproduce it as precisely as possible during the subsequent actual test procedure. During the actual test procedure, the tested participants will press a hold button when they assume the target position to allow the device to record and save the reached angle. During the data collection process, no visual (eyes will be closed) or verbal feedback will be provided for the participants.
The results of the test will be recorded and printed by the isokinetic machine. It will include the value of error of every trial and the average error of the 3 trials.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smart phone Use Experimental group | – | Other: Smart phone usePatients with CLBP |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Seventy male and female adults will be recruited from out patient clinic of the faculties of Physical therapy and medicine, Cairo University. Further, physical therapy students who are diagnosed with CLBP will be recruited via advertising on social media.
Key inclusion criteria (1 listed)
- Egyptian adult patients with mechanical CLBP Back pain duration is greater than 3 months Age ranging from 18 years to 45
Key exclusion criteria (5 listed)
- Patients with any systemic disease that may affect spine function.
- Patients with previous history of spine trauma or dysfunction other than mechanical LBP.
- Lumbosacral nerve root entrapment.
- Patients with memory loss or impaired cognitive function
- patients who report back pain associated with sitting position
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 |
|---|---|---|
| Smart phone usePatients will be asked to use the smart phone while seated for either: (1) 10 minutes or (2) 30 minutes. | Other | Smart phone Use Experimental group |
Primary outcome
Pain
Time frame: same day
Current pain intensity will be measured using the Visual Analogue Scale (VAS). This scale is a 100 mm line drawn on a piece of paper. The line is labeled 0 at one end (indicating no pain) and 10 at the other end (indicating excruciating pain). A change of minimally 20 mm on VAS is considered a minimal detectable change.
1 secondary outcome
Back repositioning error in flexion direction
Time frame: Same day
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 21 May 2019.
- Background: PubMed 26629465Alhalabi MS, Alhaleeb H, Madani S. Risk factors associated with chronic low back pain in Syria. Avicenna J Med. 2015 Oct-Dec;5(4):110-6. doi: 10.4103/2231-0770.165123.
- Background: PubMed 24932451Ali M, Asim M, Danish SH, Ahmad F, Iqbal A, Hasan SD. Frequency of De Quervain's tenosynovitis and its association with SMS texting. Muscles Ligaments Tendons J. 2014 May 8;4(1):74-8. eCollection 2014 Jan.
- Background: PubMed 11251764Atlas SJ, Deyo RA. Evaluating and managing acute low back pain in the primary care setting. J Gen Intern Med. 2001 Feb;16(2):120-31. doi: 10.1111/j.1525-1497.2001.91141.x.
- Background: PubMed 21982256Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
- BackgroundBalakrishnan, R., Chinnavan, E., & Feii, T. (2016). An extensive usage of hand held devices will lead to musculoskeletal disorder of upper extremity among student in AMU : A survey method. International Journal of Physical Education, Sport and Health, 3(2), 368-372.
- Background: PubMed 11733293Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.
- Background: PubMed 17702212Chany AM, Marras WS, Burr DL. The effect of phone design on upper extremity discomfort and muscle fatigue. Hum Factors. 2007 Aug;49(4):602-18. doi: 10.1518/001872007X215683.
- Background: PubMed 8844907Borenstein DG. Chronic low back pain. Rheum Dis Clin North Am. 1996 Aug;22(3):439-56. doi: 10.1016/s0889-857x(05)70281-7.
- Background: PubMed 26967038Chiang HY, Liu CH. Exploration of the associations of touch-screen tablet computer usage and musculoskeletal discomfort. Work. 2016 Mar 10;53(4):917-25. doi: 10.3233/WOR-162274.
- Background: PubMed 2945917Deyo RA. Early diagnostic evaluation of low back pain. J Gen Intern Med. 1986 Sep-Oct;1(5):328-38. doi: 10.1007/BF02596214. No abstract available.
- Background: PubMed 686873Downie WW, Leatham PA, Rhind VM, Wright V, Branco JA, Anderson JA. Studies with pain rating scales. Ann Rheum Dis. 1978 Aug;37(4):378-81. doi: 10.1136/ard.37.4.378.
- Background: PubMed 14508689Drouin JM, Valovich-mcLeod TC, Shultz SJ, Gansneder BM, Perrin DH. Reliability and validity of the Biodex system 3 pro isokinetic dynamometer velocity, torque and position measurements. Eur J Appl Physiol. 2004 Jan;91(1):22-9. doi: 10.1007/s00421-003-0933-0. Epub 2003 Sep 24.
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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
Dina Othman Shokri, PhD study director
Faculty of Physical Therapy, Badr 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 Mechanical Low Back Pain, run by Aliaa Rehan Youssef 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 1 inclusion and 5 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 21 May 2019. 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?
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 (time frame: same day). 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 NCT03517410, which also lists 43 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 21 May 2019.