Scoliosis IdiopathicNCT04881591
Improving Adherence and Safety of Orthopedic Treatment of Idiopathic Scoliosis in Adolescents Using Information and Communication Technologies
A study testing Treatment as usual + APP in people with Scoliosis Idiopathic and Scoliosis; Adolescence, run by Universitat Jaume I at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis Idiopathic, Scoliosis; Adolescence, Brace
- What is being tested?
- Treatment as usual + APP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2021to 31 Dec 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Vall d'Hebron Hospital
Barcelona
Judith Sanchez, jusanchez@vhebron.net
About this study
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).
Read the 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.
- Conditions
- Scoliosis Idiopathic, Scoliosis; Adolescence, Brace
- Being tested
- Treatment as usual + APP
- Keywords
- ICT, Treatment Adherence, Treatment efficacy, Treatment safety
- Medical subject headings
- Scoliosis, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as usual + APPDevice
Participants at this condition will receive the usual medical treatment for their scoliosis but also they will be monitored daily using the Scoliosis Pain Monitor APP. Alarms will be generated in the face of certain preestablished undesired events. Physicians will be asked to call patients and change/stop treatment if an alarm is received.
| Study group | Role | What they receive |
|---|---|---|
| APP+Usual Treatment | Experimental | Participants at this condition will receive the usual medical treatment for their scoliosis but also they will be monitored daily using the Scoliosis Pain Monitor APP. Alarms will be generated in the face of certain preestablished undesired events. Physicians will be asked to call patients and change/stop treatment if an alarm is received. Receives: Device: Treatment as usual + APP |
What is being measured
The primary outcome is the main question the study is designed to answer.
App' usability will be assessed by the SUS
The System Usability Scale will be administered to assess the perception that a tool is simple to use and useful. It is composed by 10 items which are responded according to a 5-point Likert scale (1 = "completely disagree" to 5 ="completely agree"). Half of the items are recorded so that higher scores in the scale represent higher usability. Total scores are converted into percentages from 0% to 100%.
Measured: During the app use (one week after app first use)
App' usability will be assessed by the SUS
The System Usability Scale will be administered to assess the perception that a tool is simple to use and useful. It is composed by 10 items which are responded according to a 5-point Likert scale (1 = "completely disagree" to 5 ="completely agree"). Half of the items are recorded so that higher scores in the scale represent higer usability. Total scores are converted into percentages from 0% to 100%.
Measured: Immediately after the app use (3 months after app first use)
App' acceptability will be assessed by the SUS
The System Usability Scale will be administered to assess the perception that a tool is simple to use and useful. It is composed by 10 items which are responded according to a 5-point Likert scale (1 = "completely disagree" to 5 ="completely agree"). Half of the items are recorded so that higher scores in the scale represent higer usability. Total scores are converted into percentages from 0% to 100%.
Measured: During the app use (one week after app first use)
App' acceptability will be assessed by the SUS
The System Usability Scale will be administered to assess the perception that a tool is simple to use and useful. It is composed by 10 items which are responded according to a 5-point Likert scale (1 = "completely disagree" to 5 ="completely agree"). Half of the items are recorded so that higher scores in the scale represent higer usability. Total scores are converted into percentages from 0% to 100%.
Measured: Immediately after the app use (3 months after app first use)
Feasibility of the study will be assessed by a calculation of responses completed
Percentage of completed assessments in the app compared to the number of planned evaluations will be calculated
Measured: Immediately after the app use (3 months after app first use)
Secondary outcomes (7)
Stress
It will be measured with the Sobberheim Stress Questionnaire (BSSQ brace). It contains 8 items responded based on a 4-points Likert scale (0= "most stress" to 3 = "least stress"). Total scores range from 0 to 24, higher total scores indicating lower stress.
Measured: Twice: at baseline (beggining of the study, before the brace use) and at end of the study (3 months after app first use)
Patients' Quality of life
It will be measured with the Italian Spine Youth Quality Of Life (ISYQOL). It is composed by 20 items responded by a 3-points Likert scale (0= "never"; 1 = "sometimes"; 2= "often").Total scores are converted into percentages from 0% to 100%, higher percentages indicating greater quality of life.
Measured: Twice: at baseline (beggining of the study, before the brace use) and at end of the study (3 months after app first use)
Perceived health status
It will be measured with the Scoliosis Research Society -22 (SRS-22). It is composed by 22 items, response rate range from 1= "Severe" to 5= "None". Total score range from 22 to 110, higher scores indicating greater perceived health status.
Measured: Twice: at baseline (beggining of the study, before the brace use) and at end of the study (3 months after app first use)
Anxiety and depressive symptoms
It will be measured with the Hospital Anxiety and Depression Scale (HADS). It consists of 14 items. Each item is rated according to a 4-point Likert scale from 0= "as much as I always do" to 3 = "not at all". Total scores range between 0 and 21, higher scores represent higher anxiety and depressive symptoms.
Measured: Twice: at baseline (beggining of the study, before the brace use) and at end of the study (3 months after app first use)
Mood
Questions adapted and validated from the Profile of Mood States and Short Form 12
Measured: Daily up to 3 months
Brace adherence
Adherence will be calculated by dividing the number of hours of use reported and the prescription filled
Measured: Daily up to 3 months
Treatment safety: Brace-related side effects
An ad hoc question will be created including the most frequent side effects according to the literature and to professionals clinical expertise
Measured: Daily up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start1 Jun 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One condition
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Azucena García-Palacios, PhD, Study chair, Universitat Jaume IJudith Sánchez-Raya, PhD, Study chair, Hospitla Universitario Vall d'HebronAmanda Díaz-García, PhD, Study chair, Universidad de ZaragozaDiana Castilla, PhD, Study chair, University of ValenciaVerónica Martínez-Borba, MsC, Study chair, Universitat Jaume I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881591
- Sponsor's protocol ID
- ScoliosisAPP
- Status last verified
- Jul 2021
- First submitted
- 7 Apr 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only Dra. Sánchez-Raya will be able to access to individual participant data.
Publications
Aebi M. The adult scoliosis. Eur Spine J. 2005 Dec;14(10):925-48. doi: 10.1007/s00586-005-1053-9. Epub 2005 Nov 18.
PubMed 16328223Charosky S, Guigui P, Blamoutier A, Roussouly P, Chopin D; Study Group on Scoliosis. Complications and risk factors of primary adult scoliosis surgery: a multicenter study of 306 patients. Spine (Phila Pa 1976). 2012 Apr 15;37(8):693-700. doi: 10.1097/BRS.0b013e31822ff5c1.
PubMed 22504517D'Astous JL, Sanders JO. Casting and traction treatment methods for scoliosis. Orthop Clin North Am. 2007 Oct;38(4):477-84, v. doi: 10.1016/j.ocl.2007.03.006.
PubMed 17945127Dunn J, Henrikson NB, Morrison CC, Blasi PR, Nguyen M, Lin JS. Screening for Adolescent Idiopathic Scoliosis: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2018 Jan 9;319(2):173-187. doi: 10.1001/jama.2017.11669.
PubMed 29318283Fong DY, Lee CF, Cheung KM, Cheng JC, Ng BK, Lam TP, Mak KH, Yip PS, Luk KD. A meta-analysis of the clinical effectiveness of school scoliosis screening. Spine (Phila Pa 1976). 2010 May 1;35(10):1061-71. doi: 10.1097/BRS.0b013e3181bcc835.
PubMed 20393399Janicki JA, Alman B. Scoliosis: Review of diagnosis and treatment. Paediatr Child Health. 2007 Nov;12(9):771-6. doi: 10.1093/pch/12.9.771.
PubMed 19030463Lenssinck ML, Frijlink AC, Berger MY, Bierman-Zeinstra SM, Verkerk K, Verhagen AP. Effect of bracing and other conservative interventions in the treatment of idiopathic scoliosis in adolescents: a systematic review of clinical trials. Phys Ther. 2005 Dec;85(12):1329-39.
PubMed 16305271Morton A, Riddle R, Buchanan R, Katz D, Birch J. Accuracy in the prediction and estimation of adherence to bracewear before and during treatment of adolescent idiopathic scoliosis. J Pediatr Orthop. 2008 Apr-May;28(3):336-41. doi: 10.1097/BPO.0b013e318168d154.
PubMed 18362800Negrini S, Atanasio S, Zaina F, Romano M. Rehabilitation of adolescent idiopathic scoliosis: results of exercises and bracing from a series of clinical studies. Europa Medicophysica-SIMFER 2007 Award Winner. Eur J Phys Rehabil Med. 2008 Jun;44(2):169-76.
PubMed 18418337Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.
PubMed 29435499Reichel D, Schanz J. Developmental psychological aspects of scoliosis treatment. Pediatr Rehabil. 2003 Jul-Dec;6(3-4):221-5. doi: 10.1080/13638490310001644593.
PubMed 14713589Suso-Ribera C, Castilla D, Zaragoza I, Ribera-Canudas MV, Botella C, Garcia-Palacios A. Validity, Reliability, Feasibility, and Usefulness of Pain Monitor: A Multidimensional Smartphone App for Daily Monitoring of Adults With Heterogenous Chronic Pain. Clin J Pain. 2018 Oct;34(10):900-908. doi: 10.1097/AJP.0000000000000618.
PubMed 29659375Tones M, Moss N, Polly DW Jr. A review of quality of life and psychosocial issues in scoliosis. Spine (Phila Pa 1976). 2006 Dec 15;31(26):3027-38. doi: 10.1097/01.brs.0000249555.87601.fc.
PubMed 17173000Weinstein SL, Dolan LA, Cheng JC, Danielsson A, Morcuende JA. Adolescent idiopathic scoliosis. Lancet. 2008 May 3;371(9623):1527-37. doi: 10.1016/S0140-6736(08)60658-3.
PubMed 18456103Yaman O, Dalbayrak S. Idiopathic scoliosis. Turk Neurosurg. 2014;24(5):646-57. doi: 10.5137/1019-5149.JTN.8838-13.0.
PubMed 25269032