Adherence to Exercises for Low Back Pain.

NCT ID: NCT06070415

Last Updated: 2024-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-20

Study Completion Date

2024-06-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Treatment Adherence Treatment Compliance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two arms study, experimental vs control
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

Home exercise assisted with a chatbot

Group Type EXPERIMENTAL

Chatbot

Intervention Type DEVICE

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

Education

Intervention Type OTHER

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

Control

Home exercise, usual care

Group Type ACTIVE_COMPARATOR

Home exercise, usual care

Intervention Type OTHER

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

Education

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Chatbot

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

Intervention Type DEVICE

Home exercise, usual care

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

Intervention Type OTHER

Education

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Valencia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David Hernández-Guillén

University teacher, PT, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Hernández-Guillén

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

David Hernández Guillén

Valencia, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHATBOT_LOW_BACK_PAIN

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.