Association Between the Duration of Smart Phone Use and Back Dysfunction in Patients With Low Back Pain

May 19, 2019 updated by: Aliaa Rehan Youssef

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

  1. Increased back pain as measured by the Visual Analogue Scale (VAS)
  2. Reduced proprioception acuity as indicated by increased angle of error of back repositioning as measured by isokinetic dynamometer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Physical Therapy, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Egyptian adult patients with mechanical CLBP Back pain duration is greater than 3 months Age ranging from 18 years to 45

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Smart phone Use Experimental group
Patients with CLBP
Other: Smart phone use
Patients will be asked to use the smart phone while seated for either: (1) 10 minutes or (2) 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
same day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Back repositioning error in flexion direction
Time Frame: Same day
Back repositioning error flexion as measured using Biodex isokinetic system 3 at 30 degree angle flexion
Same day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aliaa Rehan Youssef

Investigators

  • Principal Investigator: Aliaa Rehan Youssef, PhD, Cairo University
  • Study Director: Dina Othman Shokri, PhD, Faculty of Physical Therapy, Badr University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2018

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

April 25, 2018

First Submitted That Met QC Criteria

April 25, 2018

First Posted (Actual)

May 7, 2018

Study Record Updates

Last Update Posted (Actual)

May 21, 2019

Last Update Submitted That Met QC Criteria

May 19, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MWahba

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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