Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994458
Recruitment Status : Completed
First Posted : June 21, 2019
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Khader Almhdawi, Jordan University of Science and Technology

Tracking Information
First Submitted Date  ICMJE June 17, 2019
First Posted Date  ICMJE June 21, 2019
Last Update Posted Date February 20, 2020
Actual Study Start Date  ICMJE August 1, 2019
Actual Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • Change in Visual Analog Scale (VAS) scores [ Time Frame: Change from basleine to 6 weeks will be assessed. ]
    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 [ Time Frame: Change from basleine to 6 weeks will be assessed. ]
    A measure used to evaluate disability related to low back pain. Score range is 0-100, where higher scores indicate more disability.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • Change in 12-item Short Form Health Survey (SF-12) scores [ Time Frame: Change from basleine to 6 weeks will be assessed. ]
    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 [ Time Frame: Change from basleine to 6 weeks will be assessed. ]
    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 [ Time Frame: Change from basleine to 6 weeks will be assessed. ]
    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 [ Time Frame: Change from basleine to 6 weeks will be assessed. ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of A Smartphone Application in Treating Non-Specific Low Back Pain
Official Title  ICMJE The Efficacy and Compliance of Using A Smartphone Application in Treating Non-Specific Low Back Pain Among Office Employees: A Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled trial, double blinded
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Blinded evaluators and participants are not aware which version of the program they got.
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Behavioral: Smartphone Full version application
    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.
    Other Name: Experimental
  • Behavioral: Samartphone limited version application
    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.
    Other Name: Placebo control
Study Arms  ICMJE
  • Experimental: Experimental
    Participants get the full program for 6 weeks.
    Intervention: Behavioral: Smartphone Full version application
  • Placebo Comparator: Placebo
    Participants get the placebo program for 6 weeks.
    Intervention: Behavioral: Samartphone limited version application
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2020)
41
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2019)
40
Actual Study Completion Date  ICMJE February 1, 2020
Actual Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Jordan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03994458
Other Study ID Numbers  ICMJE 20180429
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Khader Almhdawi, Jordan University of Science and Technology
Study Sponsor  ICMJE Jordan University of Science and Technology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Khader Almhdawi, Ph.D Jordan University of Science and Technology
PRS Account Jordan University of Science and Technology
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP