Neck Pain
Conditions
Brief summary
The objective of this study is to determine whether performing cervical therapeutic exercises using a serious game through a mobile application enhances treatment adherence compared to performing the same exercises at home following standard practice.
Detailed description
Participants in the study will be adults with non-specific neck pain (cervicalgia) who own a smartphone or tablet, and that give informed consent. Individuals with acute or severe conditions, such as recent surgeries or trauma, will be excluded. Before participation, they will be informed about the study and potential risks. The study is designed as a randomized clinical trial with two groups. The control group will follow a traditional home exercise program with written instructions, while the intervention group will use a personalized mobile app to guide their exercises. All participants will be asked to log their progress and any incidents in a compliance journal.
Interventions
OTHERRehbeCa mobile application
The system consists of a mobile application (to be used by patients) and a web application (to be used by physiotherapists) that allows monitoring of the patient's performance without the need for attendance, thus facilitating telerehabilitation. The mobile application consists of a serious game that aims to induce the patient to perform neck exercises, adapting to their capacity and evolution at all times through artificial intelligence. The patient's interaction with the mobile application is based on the integration of a vision-based head-tracker to track the movements of the patient's head. The web application aims to provide professionals with a tool to monitor the evolution of their patients through the data captured by the mobile application.
OTHERHome exercise program
Set of therapeutic exercises to be carried out at home. They are taught face-to-face, and also printed on a leaflet that is delivered to the participant.
Sponsors
Universitat de les Illes Balears
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Persons of legal age with cervicalgia. * Have a smart mobile device (smartphone or tablet) on which to download the App.
Exclusion criteria
* Acute musculoskeletal pathological processes or exacerbation (less than 15 days of evolution). Includes presentation of symptoms such as paraesthesia, radiating pain, loss of strength in the upper limb. * Episodes of severe pain more than 15 days of evolution. * Accident with cervical or dorsal injury within the last month. * Refusing to sign the informed consent. * Not having a device suitable for installation or lack of experience in the use of smart mobile devices. * Baseline NDI score of less than 5. * Presence of red flags: * Suspicion of fracture: advanced age, previous trauma, osteoporosis. * Suspicion of neurological involvement: loss of sensation in extremities, loss of strength or muscle mass. * Suspicion of infection: fever, night sweats. * Suspicion of cancer: Previous history of cancer, no improvement in one month of treatment, weight loss, headache, vomiting. * Suspicion of systemic disease: headache, fever, malaise, general headache, fever, malaise, unilateral skin rash (herpes).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of Compliance of the Exercise Prescription | From admission to discharge, every 15 days, up to two months. | The level of compliance is a percentage showing the difference between the self-reported performed sessions, reflected in the compliance diary, and the prescribed sessions.Possible score ranges from 0% to 100%, considering compliant participants over 80%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Pain Intensity | Baseline and every 15 days, up to two months. | Pain intensity measured with Visual Analogue Scale (VAS). Possible scores range from 0 (no pain) to 10 (worst possible pain). |
| Changes in Neck disability | Baseline and every 15 days, up to two months. | Level of disability caused by neck pain, measured by Neck Disability Index (NDI) questionnaire. NDI is widely used to evaluate the impact of neck pain on daily activities. It is a questionnaire with 10 items about pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Item responses range from 0 (no pain) to 5 (worst imaginable pain). The 10 responses are summed to a score from 0 to 50 with higher scores indicating more disability. The NDI categories are no disability (0-4 points), mild disability (5-14 points), moderate disability (15-24 points), severe disability (25-34 points) or complete disability (35-50 points) |
| Changes in Cervical Active Range of Motion | Baseline and every 15 days, up to two months. | Active Range of Motion (ROM) of the neck, measured recording real-time movements with validated ENLAZA inertial sensors (Werium Assistive Solutions S.L., 2022). ROM measurements collected will be flexion (0-45º), extension (0-45º), lateral flexion (0-45º each side), and neck rotation (0-70º each side). |
Countries
Spain
Contacts
Primary ContactIosune Salinas-Bueno, PhD
Backup ContactMaria Teresa Arbós-Berenguer, PhD
Outcome results
None listed