NCT03994458

Brief Summary

Evaluating the efficacy of a newly developed self-monitored mobile application in reducing office workers low back pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

June 17, 2019

Last Update Submit

February 19, 2020

Conditions

Low Back Pain

Keywords

Musculoskeletal RehabilitationSmartphone applicationOccupational Stress

Outcome Measures

Primary Outcomes (2)

  • 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 from basleine to 6 weeks will be assessed.

  • 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.

    Change from basleine to 6 weeks will be assessed.

Secondary Outcomes (4)

  • Change in 12-item Short Form Health Survey (SF-12) scores

    Change from basleine to 6 weeks will be assessed.

  • Change in Depression, Anxiety, and Stress Scale (DASS21) scores

    Change from basleine to 6 weeks will be assessed.

  • Change in Pittsburgh Sleep Quality Index (PSQI) scores

    Change from basleine to 6 weeks will be assessed.

  • Change in International Physical Activity Questionnaire -short form (IPAQ-SF) scores

    Change from basleine to 6 weeks will be assessed.

Study Arms (2)

Experimental

EXPERIMENTAL

Participants get the full program for 6 weeks.

Behavioral: Smartphone Full version application

Placebo

PLACEBO COMPARATOR

Participants get the placebo program for 6 weeks.

Behavioral: Samartphone limited version application

Interventions

Smartphone Full version applicationBEHAVIORAL

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.

Also known as: Experimental
Experimental
Samartphone limited version applicationBEHAVIORAL

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.

Also known as: Placebo control
Placebo

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University of Science and Technology

Irbid, 22110, Jordan

Location

MeSH Terms

Conditions

Low Back PainOccupational Stress

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Khader Almhdawi, Ph.D

    Jordan University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Blinded evaluators and participants are not aware which version of the program they got.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial, double blinded
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 17, 2019

First Posted

June 21, 2019

Study Start

August 1, 2019

Primary Completion

January 1, 2020

Study Completion

February 1, 2020

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations

JO(1)