NCT06485804

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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 19, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

June 19, 2024

Last Update Submit

July 1, 2024

Conditions

Keywords

Office WorkersClinical trial ProtocolExercise TherapyMobile ApplicationNeck PainPatient complianceSelf-managementWorkplace

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Pain intensity assessed using a Visual Analog Scale on a scale from 0 to 100.

    Pain intensity will be assessed at baseline, and at 4, and 8 weeks of follow-up.

Secondary Outcomes (3)

  • Function

    Function will be assessed at baseline, and at 4, and 8 weeks of follow-up.

  • Quality of life measure

    Quality of life will be assessed at baseline, and at 4, and 8 weeks of follow-up.

  • Patient adherence

    Patient adherence will be assessed at 4, and 8 weeks of follow-up.

Other Outcomes (7)

  • Gender

    Assessed at baseline

  • Age

    Assessed at baseline

  • Body mass index (BMI)

    Assessed at baseline

  • +4 more other outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in the intervention group will use a smartphone application which will provide an individualized exercises program.

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

Interventions

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.

Intervention group

Eligibility Criteria

Age30 Years - 63 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The presence of a chronic NP lasting for more than three months, and a pain level at baseline assessment ≥ 30 (VAS)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Neck PainPatient Compliance

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Sana Salah, Professor

    University of Monastir

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anis Jellad, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 19, 2024

First Posted

July 3, 2024

Study Start

July 15, 2024

Primary Completion

August 31, 2024

Study Completion

October 31, 2024

Last Updated

July 3, 2024

Record last verified: 2024-07