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Adherence to Exercises for Low Back Pain.

Adherence to Home Treatment of Patients With Low Back Pain Through the Use of Information and Communication Technologies.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06070415
Enrollment
69
Registered
2023-10-06
Start date
2023-09-20
Completion date
2024-06-20
Last updated
2024-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment Adherence, Treatment Compliance

Keywords

Treatment adherence, New technologies, Lowback pain

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.

Interventions

DEVICEChatbot

12 week- intervention consisting of messages with an explanatory video of each exercise indicating how to do it and how many repetitions to perform

12 week- intervention. Printed sheets indicating how to exercises and how many repetitions to perform

OTHEREducation

One-week, three sessions in alternate days, outpatient supervised education on how to perform the exercises at home

Sponsors

University of Valencia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

The interventor providing the education sessions will be blinded to group allocation The outcome assessor will be blinded to the interventions

Intervention model description

Two arms study, experimental vs control

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adherence0 weeks, 12 weeksRecord of the number of sessions performed.

Secondary

MeasureTime frameDescription
Visual analogue scale (VAS)0 weeks, 12 weeksNumerical scale from 0 to 10, where 0 indicates no pain and 10 is the maximum pain experienced.
Disability0 weeks, 12 weeksThe Oswetry Disability Index (ODI) scale, each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
Satisfaction scale with the treatment received12 weeksThe CRES-4 satisfaction scale consists of four items designed to evaluate whether patients are satisfied with the therapy they have received and whether it has been perceived as effective. Its global score is intended to reflect treatment effectiveness as perceived by the patient. It is a good complementary tool to judge, in particular, satisfaction with the treatment received. Consists of four questions, and score with a score ranging from 0 to 18 points. The more points, the more satisfied you are with the treatment.
Sistem usability scale12 weeksIt consists of a 10 item questionnaire for measuring the usability of the experimental intervention tool with five response options for respondents, from Strongly agree to Strongly disagree

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026