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

NCT ID: NCT03994458

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2020-02-01

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental

Participants get the full program for 6 weeks.

Group Type: EXPERIMENTAL

Smartphone Full version application

Intervention Type: BEHAVIORAL

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.

Placebo

Participants get the placebo program for 6 weeks.

Group Type: PLACEBO_COMPARATOR

Samartphone limited version application

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Experimental; Placebo control

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jordan University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Khader Almhdawi

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khader Almhdawi, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Jordan University of Science and Technology

Locations

Jordan University of Science and Technology

Irbid, , Jordan

Countries

Jordan

Other Identifiers

20180429

Identifier Type: -

Identifier Source: org_study_id