AI Mobile App vs Self Exercises in Workers With Neck Pain

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neck Pain; Work-Related Condition
• Intervention / Treatment: Other: Smartphone application guided exercises

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anis Jellad, Professor; Phone Number: 98210626; Email: anisjellad@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Participants in the intervention group will use a smartphone application which will provide an individualized exercises program.	Other: Smartphone application guided exercises; 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.
No Intervention: Control group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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)	Patient adherence will be assessed at 4, and 8 weeks of follow-up.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gender	Gender: Female, Male.	Assessed at baseline
Age	Age in terms of years	Assessed at baseline
Body mass index (BMI)	BMI is calculated as follows: BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height (in metres) squared.	Assessed at baseline
Comorbidities	Comorbidities comprise: Diabetes, Hypertension, Thyroid disorders, Cardiovascular and Lung diseases, and Cancer history.	Assessed at baseline
Musculoskeletal disorders	Musculoskeletal disorders comprise: Osteoarthrities, Rheumatic arthritis, Osteoporosis, and Tendinopathies.	Assessed at baseline
Work seniority	Work seniority: Length of work service (years).	Assessed at baseline
Time spent in front of computer	Time spent in front of computer: average number of daily hours spent in front of computer.	Assessed at baseline

Collaborators and Investigators

• Sponsor: University of Monastir
• Collaborators: Sana Salah; Amr Chaabeni
• Investigators: Principal Investigator: Sana Salah, Professor, University of Monastir

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2024
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Neck Pain; Workplace; Mobile Application; Self-management; Exercise Therapy; Patient compliance; Office Workers; Clinical trial Protocol
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: AIMobApp-Neck-Pain

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No