Low Back PainNCT03994458
The Efficacy of A Smartphone Application in Treating Non-Specific Low Back Pain
A study testing Smartphone Full version application and Samartphone limited version application in people with Low Back Pain, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
Evaluating the efficacy of a newly developed self-monitored mobile application in reducing office workers low back pain. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Smartphone Full version application and Samartphone limited version application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteJordan
- Study dates
- 1 Aug 2019to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Evaluating the efficacy of a newly developed self-monitored mobile application in reducing office workers low back pain.
Read the 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:
- 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).
- 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).
- 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
- Being tested
- Smartphone Full version application, Samartphone limited version application
- Keywords
- Musculoskeletal Rehabilitation, Smartphone application, Occupational Stress
- Medical subject headings
- Low Back Pain, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone Full version applicationBehavioural
Also called Experimental
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.
Samartphone limited version applicationBehavioural
Also called Placebo control
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants get the full program for 6 weeks. Receives: Behavioral: Smartphone Full version application |
| Placebo | Placebo comparator | Participants get the placebo program for 6 weeks. Receives: Behavioral: Samartphone limited version application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from basleine to 6 weeks will be assessed.
Secondary outcomes (4)
Change in 12-item Short Form Health Survey (SF-12) scores
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.
Measured: Change from basleine to 6 weeks will be assessed.
Change in Depression, Anxiety, and Stress Scale (DASS21) scores
A measure used to assess mental health symptoms over the last week. Score range is 0-21, where higher scores indicate worse mental health.
Measured: Change from basleine to 6 weeks will be assessed.
Change in Pittsburgh Sleep Quality Index (PSQI) scores
The PSQI assess sleep quality over previous month.Score range is 0-21, where higher scores indicate worse sleep quality.
Measured: Change from basleine to 6 weeks will be assessed.
Change in International Physical Activity Questionnaire -short form (IPAQ-SF) scores
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.
Measured: Change from basleine to 6 weeks will be assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start1 Aug 2019
- Primary completion1 Jan 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial, double blinded
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khader Almhdawi, Jordan University of Science and Technology
- Investigators
- Khader Almhdawi, Ph.D, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994458
- Sponsor's protocol ID
- 20180429
- Status last verified
- Feb 2020
- First submitted
- 17 Jun 2019
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03994458
- Acronym / sponsor ID
- 20180429
- Conditions
- Low Back Pain
- Keywords
- Musculoskeletal Rehabilitation, Smartphone application, Occupational Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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).
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial, double blinded
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Smartphone Full version applicationParticipants get the full program for 6 weeks. |
| Placebo | Placebo comparator | Behavioral: Samartphone limited version applicationParticipants get the placebo program for 6 weeks. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Pregnancy.
- Diagnosed with disc herniation with radiculopathy pain.
- Structural deformities as in Scoliosis, or Kyphosis, or Lordosis.
- Spinal tumor.
- Ankylosing spondylitis, spondylolisthesis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone Full version applicationAlso: ExperimentalAndroid 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. | Behavioural | Experimental |
| Samartphone limited version applicationAlso: Placebo controlAndroid 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. | Behavioural | Placebo |
Primary outcome
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.
4 secondary outcomes
Change in 12-item Short Form Health Survey (SF-12) scores
Time frame: Change from basleine to 6 weeks will be assessed.
Change in Depression, Anxiety, and Stress Scale (DASS21) scores
Time frame: Change from basleine to 6 weeks will be assessed.
Change in Pittsburgh Sleep Quality Index (PSQI) scores
Time frame: Change from basleine to 6 weeks will be assessed.
Change in International Physical Activity Questionnaire -short form (IPAQ-SF) scores
Time frame: Change from basleine to 6 weeks will be assessed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khader Almhdawi, Ph.D principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone Full version application and Samartphone limited version application in people with Low Back Pain, run by Jordan University of Science and Technology at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale (VAS) scores (time frame: Change from basleine to 6 weeks will be assessed.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.