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The Efficacy of A Smartphone Application in Treating Non-Specific Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Smartphone Full version application
Samartphone limited version application
Sponsored by
Jordan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Musculoskeletal Rehabilitation, Smartphone application, Occupational Stress

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Being office worker for at least 5 years with at least 5 hours of working daily behind the desk.
  2. Middle age adults, age between 30 and 55 years old.
  3. Complains of LBP at least for 3 months measured by self-report
  4. Scored at least 3 point on a 0-10 Visual Analog Scale.
  5. Owning an android smartphone.

Exclusion Criteria:

  1. Pregnancy.
  2. Diagnosed with disc herniation with radiculopathy pain.
  3. Structural deformities as in Scoliosis, or Kyphosis, or Lordosis.
  4. Spinal tumor.
  5. Ankylosing spondylitis, spondylolisthesis.
  6. Had a spine surgery or significant trauma in the past 6 months.
  7. Low mental ability of not being able to use smartphone.

Sites / Locations

  • Jordan University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Placebo

Arm Description

Participants get the full program for 6 weeks.

Participants get the placebo program for 6 weeks.

Outcomes

Primary Outcome Measures

Change in Visual Analog Scale (VAS) scores
A measure used to evaluate pain related to low back pain. Score range is 0-10, where higher scores indicate more pain.
Change in Oswestry Disability Questionnaire (ODQ) scores
A measure used to evaluate disability related to low back pain. Score range is 0-100, where higher scores indicate more disability.

Secondary Outcome Measures

Change in 12-item Short Form Health Survey (SF-12) scores
A measure of health related quality of life includes Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Score range is 0-100, where higher scores indicate better health related quality of life.
Change in Depression, Anxiety, and Stress Scale (DASS21) scores
A measure used to assess mental health symptoms over the last week. Score range is 0-21, where higher scores indicate worse mental health.
Change in Pittsburgh Sleep Quality Index (PSQI) scores
The PSQI assess sleep quality over previous month.Score range is 0-21, where higher scores indicate worse sleep quality.
Change in International Physical Activity Questionnaire -short form (IPAQ-SF) scores
A measure collects the occurrence and time of physical activity with continuous high, moderate and low intensity for at least ten minutes during the previous 7 days. A higher score in this measure indicates higher physical activity level.

Full Information

First Posted
June 17, 2019
Last Updated
February 19, 2020
Sponsor
Jordan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03994458
Brief Title
The Efficacy of A Smartphone Application in Treating Non-Specific Low Back Pain
Official Title
The Efficacy and Compliance of Using A Smartphone Application in Treating Non-Specific Low Back Pain Among Office Employees: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jordan University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluating the efficacy of a newly developed self-monitored mobile application in reducing office workers low back pain.
Detailed Description
II. Introduction and Hypothesis of the Study: Around 12% to 33% of the adult workforce are affected by low back pain (LBP) each year. Furthermore 70% to 95% of the adults are predicted to have back pain at least once in their lifetime (Van Tulder et al., 2006, Karthikeyan et al., 2013). There are numerus applications for self-management of LBP. These applications provided patients with cost-effective alternative management for their LBP. However, most of these available applications are of a low quality, because they were developed without an evidence-based vision (Machado et al., 2016). Hypothesis: All participants who will use the full access of the LBP application for six weeks will demonstrate significant decrease in low back pain intensity as measured by Visual Analogue Scale (VAS). All participants who will use the full access of the LBP application for six weeks will demonstrate significant decrease in disability as measured by Oswestry Disability Index (ODI). All participants who will use the full access of the LBP application for six weeks will demonstrate significant perceptual satisfaction and gained benefit as measured by self-rated survey questions. III. Aims of the study: This study aims to evaluate the efficacy and compliance in using a standardized evidence-based LBP application among office employees who suffer from non-specific LBP, in randomized controlled trial. IV. Materials and Methods: A smartphone application will be programed to deliver home-based exercises and advices targeting LBPP. 30 participants who has LBP, had been at least 5 years office worker have a 5 hours of working, will be recruited for a randomized controlled trial, participants who have any spine or spinal cord disease will be excluded. Participants will be compared according who will get full access to the application for non-specific LBP management with those who will get a limited version of the application. Both groups will use their versions of the application for 6 weeks, a follow-up will be done after 6 weeks. Visual Analog Scale (VAS), will be used to assess intensity of the LBP, and Oswestry Disability Index (ODI) will be used to assess the disability that had been caused by LBP. Descriptive statistics will be represented in means and standard deviations. Change scores between groups (experimental vs control) will be compared using ANCOVA model.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Musculoskeletal Rehabilitation, Smartphone application, Occupational Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial, double blinded
Masking
ParticipantOutcomes Assessor
Masking Description
Blinded evaluators and participants are not aware which version of the program they got.
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Participants get the full program for 6 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants get the placebo program for 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Smartphone Full version application
Other Intervention Name(s)
Experimental
Intervention Description
Android smartphone experimental application include: rehabilitative self-administered evidence-based exercises (Strengthening and stretching), ergonomics, and education related to low back pain. The application includes videos, photos, text, and reminders.
Intervention Type
Behavioral
Intervention Name(s)
Samartphone limited version application
Other Intervention Name(s)
Placebo control
Intervention Description
Android smartphone placebo application include: ineffective content that does not help in treating low back pain. The application includes only five posts in the general instruction and advises section about proper nutrition and few irrelevant reminders.
Primary Outcome Measure Information:
Title
Change in Visual Analog Scale (VAS) scores
Description
A measure used to evaluate pain related to low back pain. Score range is 0-10, where higher scores indicate more pain.
Time Frame
Change from basleine to 6 weeks will be assessed.
Title
Change in Oswestry Disability Questionnaire (ODQ) scores
Description
A measure used to evaluate disability related to low back pain. Score range is 0-100, where higher scores indicate more disability.
Time Frame
Change from basleine to 6 weeks will be assessed.
Secondary Outcome Measure Information:
Title
Change in 12-item Short Form Health Survey (SF-12) scores
Description
A measure of health related quality of life includes Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Score range is 0-100, where higher scores indicate better health related quality of life.
Time Frame
Change from basleine to 6 weeks will be assessed.
Title
Change in Depression, Anxiety, and Stress Scale (DASS21) scores
Description
A measure used to assess mental health symptoms over the last week. Score range is 0-21, where higher scores indicate worse mental health.
Time Frame
Change from basleine to 6 weeks will be assessed.
Title
Change in Pittsburgh Sleep Quality Index (PSQI) scores
Description
The PSQI assess sleep quality over previous month.Score range is 0-21, where higher scores indicate worse sleep quality.
Time Frame
Change from basleine to 6 weeks will be assessed.
Title
Change in International Physical Activity Questionnaire -short form (IPAQ-SF) scores
Description
A measure collects the occurrence and time of physical activity with continuous high, moderate and low intensity for at least ten minutes during the previous 7 days. A higher score in this measure indicates higher physical activity level.
Time Frame
Change from basleine to 6 weeks will be assessed.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being office worker for at least 5 years with at least 5 hours of working daily behind the desk. Middle age adults, age between 30 and 55 years old. Complains of LBP at least for 3 months measured by self-report Scored at least 3 point on a 0-10 Visual Analog Scale. Owning an android smartphone. Exclusion Criteria: Pregnancy. Diagnosed with disc herniation with radiculopathy pain. Structural deformities as in Scoliosis, or Kyphosis, or Lordosis. Spinal tumor. Ankylosing spondylitis, spondylolisthesis. Had a spine surgery or significant trauma in the past 6 months. Low mental ability of not being able to use smartphone.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khader Almhdawi, Ph.D
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jordan University of Science and Technology
City
Irbid
ZIP/Postal Code
22110
Country
Jordan

12. IPD Sharing Statement

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The Efficacy of A Smartphone Application in Treating Non-Specific Low Back Pain

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