Clinical trial NCT03994458: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Musculoskeletal Rehabilitation
Smartphone application
Occupational Stress
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 41
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial, double blinded
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Visual Analog Scale (VAS) scores
timeFrame: Change from basleine to 6 weeks will be assessed.
measure: Change in Oswestry Disability Questionnaire (ODQ) scores
timeFrame: Change from basleine to 6 weeks will be assessed.
Secondary outcomes:
measure: Change in 12-item Short Form Health Survey (SF-12) scores
timeFrame: Change from basleine to 6 weeks will be assessed.
measure: Change in Depression, Anxiety, and Stress Scale (DASS21) scores
timeFrame: Change from basleine to 6 weeks will be assessed.
measure: Change in Pittsburgh Sleep Quality Index (PSQI) scores
timeFrame: Change from basleine to 6 weeks will be assessed.
measure: Change in International Physical Activity Questionnaire -short form (IPAQ-SF) scores
timeFrame: Change from basleine to 6 weeks will be assessed.
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of Science and Technology
Study officials:
affiliation: Jordan University of Science and Technology
name: Khader Almhdawi, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: