Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT03994458
Status:
COMPLETED
Last Update Posted:
2020-02-20
First Post:
2019-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy of A Smartphone Application in Treating Non-Specific Low Back Pain
Sponsor:
Jordan University of Science and Technology
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
1. 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).
2. 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).
3. 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.
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:
1. 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).
2. 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).
3. 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: