Clinical trial NCT05704023: Effects of a Mobile App on Adherence to Daily Exercise and Recovery After Whiplash Injury
Official title: Effects of a Mobile App on Adherence to Daily Exercise and Recovery After Whiplash Injury - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Whiplash Injury of Cervical Spine
Keywords: Whiplash
Adherence
Recovery
Mobile app
Lead sponsor: University of Split, School of Medicine
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the effect of daily mobile app reminders to exercise in conjunction with standard physical therapy on adherence to exercise and recovery after whiplash injury of the neck. Participants will be divided into two groups, the experimental (Arm A) and control group (Arm B). Both groups will complete a standard physical therapy program under the supervision of a physiotherapist. Both groups will get illustrated home exercise programs and will be advised to continue exercising at home. In addition, the experimental group will receive one daily push notification via a mobile app to perform a daily exercise at home.

Detailed description: Whiplash injury of the neck is the most common injury resulting from a traffic accident. Although most people recover completely, 30 to 50% of them develop chronic neck pain and disability. Also, long sick leaves and lower productivity at work create a burden on the healthcare system.

Conservative treatment includes exercise, physical therapy modalities such as transcutaneous electric nerve stimulation (TENS), and ultrasound therapy. Although conservative treatment is recommended, the evidence of its efficacy remains unclear. Education after the injury can be beneficial in lowering anxiety and pain.

Many studies are investigating the usefulness of mobile apps in various medical conditions. In rehabilitation medicine, apps are used to increase knowledge about different conditions, as a measurement tool, and as an intervention to increase adherence to the prescribed therapy.

After the enrollment in the study, participants will complete the two-part physical therapy program (2x10 sessions, 5times/day, 3-week break in between) under the supervision of a physiotherapist at the outpatient clinic. After completing the program, the participants will get a home exercise program, group A via mobile app, and group B via papers, and will be encouraged to continue exercising at home. Also, group A will download a mobile app, "WIapp," that was developed for this purpose and will receive one daily push notification as a reminder to perform a daily exercise at home.

The investigators hypothesize that daily reminding to exercise via mobile app can increase adherence to prescribed therapy and overall increase recovery.

Eligibility criteria: Inclusion Criteria:

* patients who sustained whiplash injury of the neck in a car accident as drivers or co-drivers
* diagnosed with a whiplash injury of the neck by physical and rehabilitation medicine specialist within 3 months
* Neck Disability Index (NDI) score higher than 5 (10%)
* possession of and ability to use a smartphone and a mobile app
* age ≥ 18 years
* signed written informed consent

Exclusion Criteria:

* bone fracture sustained in the accident
* spinal cord injury
* accident in any other type of vehicle other than car
* treatment of malignant disease in the last 5 years
* expected non-compliance (not possible to use a smartphone because of severe mental or physical impairment)

Primary outcomes:
measure: Change in Neck Disability Index from baseline to 6 months after the injury
timeFrame: baseline, 6 months after the injury
Secondary outcomes:
measure: Questionnaire assessment of adherence to exercise
timeFrame: 6 months after the injury
measure: Questionnaire assessment of perceived recovery
timeFrame: 6-months after the injury
measure: Change in Visual Analog Scale (VAS) Pain Score from baseline to 6 months after the injury
timeFrame: baseline, 6 months after the injury
measure: Pain catastrophizing scale
timeFrame: baseline
measure: Short Form Health Survey 12
timeFrame: baseline
measure: Questionnaire assessment of social functioning
timeFrame: baseline
measure: Questionnaire assessment work
timeFrame: baseline, 6 months after the injury
measure: Pain catastrophizing scale
timeFrame: 6 months after the injury
measure: Short Form Health Survey 12
timeFrame: 6 months after the injury
measure: Questionnaire assessment of social functioning
timeFrame: 6 months after the injury
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University Hospital Split
Study officials:
affiliation: University Hospital Split
name: Aljinović
role: STUDY_DIRECTOR
References: