Clinical trial NCT04881591: Improving Adherence and Safety of Orthopedic Treatment of Idiopathic Scoliosis in Adolescents Using Information and Communication Technologies
Official title: Improving Adherence and Safety of Orthopedic Treatment of Idiopathic Scoliosis in Adolescents Using Information and Communication Technologies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scoliosis Idiopathic
Scoliosis; Adolescence
Brace
Keywords: ICT
Treatment Adherence
Treatment efficacy
Treatment safety
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 10
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One condition
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The present project aims to test the feasibility of a new management mechanism for inter-visit monitoring of adolescent patients with idiopathic scoliosis that improves the quality and safety of current orthopedic treatments using information and communication technologies (ICT).

Detailed description: Idiopathic scoliosis is defined as a spinal deformity affecting the anteroposterior plane and exceeding 10 degrees of angulation. The label idiopathic arises from ruling out other causes, such as tumors, trauma or infections, that may explain the deformity. This pathology affects approximately 2% of the population, being up to 5 times more frequent in girls than in boys and age playing a fundamental role in the progression and worsening of the problem.

In most cases, scoliosis appears during adolescence (up to 89% of cases according to studies), being very rare up to 3 years of age (between 1% and 5% of detected cases) and slightly more frequent in the infantile stage (7 to 10.5% of scoliosis cases). Scoliosis often does not cause pain or other complications associated with the deformity. However, as the curvature deformity increases (especially after 25 degrees), complications become more pronounced and treatment becomes necessary. For example, in the case of curvatures between 30 and 40 degrees and curves between 20 and 29 degrees that have progressed rapidly in the last year (more than 5 degrees), bracing has become the indicated treatment, while more invasive intervention (surgery) will be necessary in more severe cases.

The prevalence of cases requiring treatment (by bracing or, in the worst case, surgery) is estimated to be between 0.2 and 0.3% of the population under 18 years of age. However, although in many cases scoliosis is not associated with medical complications, it has been shown that, even in people with less severe curvature, this deformity is associated with psychological complications, such as lower self-esteem, a more depressed mood, high alcohol consumption and even suicidal ideation, which are aggravated during treatment.

Through bracing, applied early on, it is hoped that the proper curvature of the spine will be aided by the guidance imposed by the brace. However, although review studies indicate promising results with this intervention, they also indicate that the use of bracing does not yet possess sufficient scientific evidence. This is mainly due, as indicated by the literature, to the low adherence to bracing in this population, which tends to be exaggerated when evaluated retrospectively. Given that one of the best predictors of the effectiveness of orthopedic treatment of scoliosis is, in fact, time in brace use, greater efforts should be made to improve adherence to treatment in this population. Some authors have proposed that factors such as beliefs about the pathology and treatment (e.g., "I don't care about my back" or "I think people will see the brace under my clothes"), as well as the undesirable effects of brace use (e.g., chafing, discomfort when sleeping, or pain), may be at least partly responsible for this low adherence.

With the aforementioned purpose in mind, we hope that the use of our Pain Monitor App, which has been recently validated in an empirical study, will allow early detection of low adherence to brace use, the appearance of undesirable effects of its use or the persistence of dysfunctional beliefs. All this with the aim of acting quickly to promote their adherence to brace use, make changes to the brace when it causes undesirable effects, or perform psychoeducational interventions when dysfunctional beliefs about scoliosis or treatment persist. As a result of the above, we expect to increase the effectiveness of the intervention (better curvature evolution) and the quality of life and emotional well-being of the patients. Avoiding progression of the curvature is important since surgery is associated with significant post-surgical complications, such as infections and mechanical and neurological problems, with low success rate and frequent need for several surgeries, while untreated scoliosis in the adult is often accompanied by chronic low back pain and significant instability.

Eligibility criteria: Inclusion Criteria:

* Adolescente patient (between 10 and 18 years old)
* Wearing a brace for less than 3 months
* The patient has a mobile phone with Android or iOS operating systems
* The patients has the physical ability to use the application
* The patient does not present psychological and or cognitive alterations/ problems with language that make their participation difficult
* The patient (or the legal tutor) voluntarily wants to participate and sings the informed consent

Exclusion Criteria:

* The patient does not have an own mobile phone or has a mobile phone with uncompatible characteristics
* Cognitive alterations, lenguage problems to understand the use of the app and to respond its questions
* The patient presents a severe mental health issues or substance abuse.

Primary outcomes:
measure: App' usability will be assessed by the SUS
timeFrame: During the app use (one week after app first use)
measure: App' usability will be assessed by the SUS
timeFrame: Immediately after the app use (3 months after app first use)
measure: App' acceptability will be assessed by the SUS
timeFrame: During the app use (one week after app first use)
measure: App' acceptability will be assessed by the SUS
timeFrame: Immediately after the app use (3 months after app first use)
measure: Feasibility of the study will be assessed by a calculation of responses completed
timeFrame: Immediately after the app use (3 months after app first use)
Secondary outcomes:
measure: Stress
timeFrame: Twice: at baseline (beggining of the study, before the brace use) and at end of the study (3 months after app first use)
measure: Patients' Quality of life
timeFrame: Twice: at baseline (beggining of the study, before the brace use) and at end of the study (3 months after app first use)
measure: Perceived health status
timeFrame: Twice: at baseline (beggining of the study, before the brace use) and at end of the study (3 months after app first use)
measure: Anxiety and depressive symptoms
timeFrame: Twice: at baseline (beggining of the study, before the brace use) and at end of the study (3 months after app first use)
measure: Mood
timeFrame: Daily up to 3 months
measure: Brace adherence
timeFrame: Daily up to 3 months
measure: Treatment safety: Brace-related side effects
timeFrame: Daily up to 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebron Hospital
Study officials:
affiliation: Universitat Jaume I
name: Azucena García-Palacios, PhD
role: STUDY_CHAIR
affiliation: Hospitla Universitario Vall d'Hebron
name: Judith Sánchez-Raya, PhD
role: STUDY_CHAIR
affiliation: Universidad de Zaragoza
name: Amanda Díaz-García, PhD
role: STUDY_CHAIR
affiliation: University of Valencia
name: Diana Castilla, PhD
role: STUDY_CHAIR
affiliation: Universitat Jaume I
name: Verónica Martínez-Borba, MsC
role: STUDY_CHAIR
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