Clinical trial NCT06070415: Adherence to Exercises for Low Back Pain.
Official title: Adherence to Home Treatment of Patients With Low Back Pain Through the Use of Information and Communication Technologies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment Adherence
Treatment Compliance
Keywords: Treatment adherence
New technologies
Lowback pain
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms study, experimental vs control
Primary purpose: OTHER

Brief summary: This project focuses on the effectiveness of a Chatbot in promoting adherence to home physiotherapy treatment for patients with lumbar musculoskeletal injuries. The use of digital technologies and media are an important option to complement in-person treatment and promote adherence to treatment at home. The research aims to verify whether the use of a Chatbot as a means of communication can produce improvements in patient adherence and clinical results.

Detailed description: Currently, performing therapeutic exercises in the treatment of musculoskeletal injuries of the spine is decisive in many cases to achieve an improvement in the symptoms of these pathologies, both in the patient's functionality and in the patient's evaluation of their pain. These types of exercises provide improvement, whether they are outpatient or at home. Due to the paradigm shift that has occurred in recent years, mainly motivated by limited resources and the COVID-19 pandemic, it is necessary to complement in-person exercise and/or teaching sessions with homework whenever possible. In addition, unnecessary travel is avoided in case patients live far from the consultation.

Adherence to treatment is crucial to obtain the desired benefits. According to the WHO (2003), adherence is the degree to which a person's behavior corresponds to the recommendations agreed upon by a healthcare professional, and it has been observed that patients who comply may have a better outcome at the end of treatment. However, not meeting a minimum of more than 65% adherence negatively influences the outcome of the patient's recovery, with probable consequences on socio-health costs.

Before the appearance of new technologies, home-type therapeutic exercises were taught in consultation and given to the patient in paper format. Nowadays, the use of information and communication technologies (ICT) and digital media are an option when administering home treatments, and thanks to these we have much more complete teaching materials. when it comes to remembering what was learned in consultation, such as the Chatbot. For this reason, we value the possibility that the use of this system can help increase adherence to treatment and therefore improve your health condition.

On the other hand, non-compliance rates with treatment are one of the main barriers when it comes to obtaining benefits for the patient. Therefore, digital applications in physiotherapy should be aimed at improving clinical outcomes and promoting adherence through interactive and accessible environments that promote self-efficacy and changes in behavior and routines, as offered by the Chatbot program. One of the most common forms of ICT use is through the use of smartphones, where half of the users of these devices use them to obtain information about health issues, and a fifth uses applications related to this area. This has expanded the offer of health-oriented mobile applications but very little research has been carried out to evaluate adherence or the level of satisfaction among users.

Eligibility criteria: Inclusion Criteria:

* Over 18 years.
* Diagnosis of lumbar pain.
* Indication of treatment through home exercises.
* With a personal smartphone
* Verbally confirms to have installed an instant messaging service or app, and accesses it at least 3 times a week

Exclusion Criteria:

* No to sign the informed consent.
* Not able to understand, read and write in the Spanish language

Primary outcomes:
measure: Adherence
timeFrame: 0 weeks, 12 weeks
Secondary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: 0 weeks, 12 weeks
measure: Disability
timeFrame: 0 weeks, 12 weeks
measure: Satisfaction scale with the treatment received
timeFrame: 12 weeks
measure: Sistem usability scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: David Hernández Guillén
Study officials:
affiliation: University of Valencia
name: David Hernández-Guillén
role: PRINCIPAL_INVESTIGATOR
References: