Neck PainNCT06485804
AI Mobile App vs Self Exercises in Workers With Neck Pain
A study testing Smartphone application guided exercises in people with Neck Pain and Work-Related Condition, run by University of Monastir.
Trial summary
This study aims to compare the impact of two different methods to administer self-exercises in administrative workers with neck pain: an Artificial Intelligence embedded mobile application and written sheet. Read more about this study
- Who is it for?
- Ages 30 to 63 years
- Conditions the study is for
- Neck Pain, Work-Related Condition
- What is being tested?
- Smartphone application guided exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2024to 31 Oct 2024
- 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 63 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The presence of a chronic NP lasting for more than three months, and a pain level at baseline assessment ≥ 30 (VAS)
Who cannot join
- Acute neck pain, neck pain from specific causes (eg; Chronic inflammatory diseases), spine trauma or surgery, cervical radiculopathy or myelopathy, and physical therapy treatments in the last six months before baseline assessment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparing Efficacy and Adherence of Smartphone-guided Exercises to Conventional Self-directed Exercises for Neck Pain in Office Workers: A Randomized Controlled Trial Protocol
This study aims to compare the impact of two different methods to administer self-exercises in administrative workers with neck pain: an Artificial Intelligence embedded mobile application and written sheet.
- Conditions
- Neck Pain, Work-Related Condition
- Being tested
- Smartphone application guided exercises
- Keywords
- Office Workers, Clinical trial Protocol, Exercise Therapy, Mobile Application, Neck Pain, Patient compliance, Self-management, Workplace
- Medical subject headings
- Neck Pain, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone application guided exercisesOther
Participants in the intervention group will use a smartphone application to execute a self-rehabilitation program. The app will integrate:
- Basic information about neck pain and ergonomic advice.
- A series of evaluation questions on pain and function.
- Appropriate sets of exercises with videos and instructions.
- Daily reminders.
- Evaluation reports providing feedback and adherence.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in the intervention group will use a smartphone application which will provide an individualized exercises program. Receives: Other: Smartphone application guided exercises |
| Control group | No intervention | Participants in the control group will receive a rehabilitation program delivered on a paper sheet containing pictures of exercises with written explanations in French, including the number of sets and repetitions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity assessed using a Visual Analog Scale on a scale from 0 to 100.
Measured: Pain intensity will be assessed at baseline, and at 4, and 8 weeks of follow-up.
Secondary outcomes (3)
Function
Patient function will be assessed using the neck disability index (NDI). The scale consists of a set of questions addressing various aspects of neck pain and its influence on activities such as personal care, lifting, reading, working, and recreation
Measured: Function will be assessed at baseline, and at 4, and 8 weeks of follow-up.
Quality of life measure
The short form 12 (SF-12) will be used to measure health-related Quality of life. The SF-12 is a shorter version of the short form 36 (SF-36) and is used to assess individual's physical and mental well-being.
Measured: Quality of life will be assessed at baseline, and at 4, and 8 weeks of follow-up.
Patient adherence
Adherence will be measured using a frequency-based response scale (ie; never, seldom, often, almost always, and always) adapted from the adherence scale of Sluijs et al. (Phys Ther 1993)
Measured: Patient adherence will be assessed at 4, and 8 weeks of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start15 Jul 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Collaborators
- Sana Salah, Amr Chaabeni
- Responsible party
- Principal investigator, Anis Jellad, University of Monastir
- Investigators
- Sana Salah, Professor, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485804
- Sponsor's protocol ID
- AIMobApp-Neck-Pain
- Status last verified
- Jul 2024
- First submitted
- 19 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Salah S, Jellad A, Mili M, Chaabeni A, Bedoui MH, Ben Saad H. Comparing efficacy and adherence of smartphone-guided exercises to conventional self-directed exercises for neck pain in office workers: A randomized controlled trial protocol. PLoS One. 2025 Sep 19;20(9):e0329863. doi: 10.1371/journal.pone.0329863. eCollection 2025.
PubMed 40971708
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Efficacy and Adherence of Smartphone-guided Exercises to Conventional Self-directed Exercises for Neck Pain in Office Workers: A Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT06485804
- Acronym / sponsor ID
- AIMobApp-Neck-Pain
- Conditions
- Neck Pain, Work-Related Condition
- Keywords
- Office Workers, Clinical trial Protocol, Exercise Therapy, Mobile Application, Neck Pain, Patient compliance, Self-management, Workplace
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Collaborators
- Sana Salah, Amr Chaabeni
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 3 Jul 2024 (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.
This study aims to compare the impact of two different methods to administer self-exercises in administrative workers with neck pain: an Artificial Intelligence embedded mobile application and written sheet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Smartphone application guided exercisesParticipants in the intervention group will use a smartphone application which will provide an individualized exercises program. |
| Control group | No intervention | –Participants in the control group will receive a rehabilitation program delivered on a paper sheet containing pictures of exercises with written explanations in French, including the number of sets and repetitions |
Who may qualify
- Ages
- 30 to 63 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The presence of a chronic NP lasting for more than three months, and a pain level at baseline assessment ≥ 30 (VAS)
Key exclusion criteria (1 listed)
- Acute neck pain, neck pain from specific causes (eg; Chronic inflammatory diseases), spine trauma or surgery, cervical radiculopathy or myelopathy, and physical therapy treatments in the last six months before baseline assessment.
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 application guided exercisesParticipants in the intervention group will use a smartphone application to execute a self-rehabilitation program. The app will integrate: * Basic information about neck pain and ergonomic advice. * A series of evaluation questions on pain and function. * Appropriate sets of exercises with videos and instructions. * Daily reminders. * Evaluation reports providing feedback and adherence. | Other | Intervention group |
Primary outcome
Pain intensity
Time frame: Pain intensity will be assessed at baseline, and at 4, and 8 weeks of follow-up.
Pain intensity assessed using a Visual Analog Scale on a scale from 0 to 100.
3 secondary outcomes
Function
Time frame: Function will be assessed at baseline, and at 4, and 8 weeks of follow-up.
Quality of life measure
Time frame: Quality of life will be assessed at baseline, and at 4, and 8 weeks of follow-up.
Patient adherence
Time frame: Patient adherence will be assessed at 4, and 8 weeks of follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 40971708Salah S, Jellad A, Mili M, Chaabeni A, Bedoui MH, Ben Saad H. Comparing efficacy and adherence of smartphone-guided exercises to conventional self-directed exercises for neck pain in office workers: A randomized controlled trial protocol. PLoS One. 2025 Sep 19;20(9):e0329863. doi: 10.1371/journal.pone.0329863. eCollection 2025.
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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.
Sana Salah, Professor principal investigator
University of Monastir
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone application guided exercises in people with Neck Pain and Work-Related Condition, run by University of Monastir.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anis Jellad, Professor (98210626, anisjellad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Pain intensity will be assessed at baseline, and at 4, and 8 weeks of follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06485804, which also lists 1 linked publication.
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 3 Jul 2024.