Adherence to Exercises for Low Back Pain.

Sponsor
University of Valencia (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06070415
Collaborator
(none)
50
1
2
9
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Chatbot
  • Other: Home exercise, usual care
  • Other: Education
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two arms study, experimental vs controlTwo arms study, experimental vs control
Masking:
Double (Care Provider, 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
Primary Purpose:
Other
Official Title:
Adherence to Home Treatment of Patients With Low Back Pain Through the Use of Information and Communication Technologies.
Actual Study Start Date :
Sep 20, 2023
Anticipated Primary Completion Date :
May 20, 2024
Anticipated Study Completion Date :
Jun 20, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental

Home exercise assisted with a chatbot

Device: 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

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

Active Comparator: Control

Home exercise, usual care

Other: Home exercise, usual care
12 week- intervention. Printed sheets indicating how to exercises and how many repetitions to perform

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

Outcome Measures

Primary Outcome Measures

  1. Adherence [0 weeks, 12 weeks]

    Record of the number of sessions performed.

Secondary Outcome Measures

  1. Visual analogue scale (VAS) [0 weeks, 12 weeks]

    Numerical scale from 0 to 10, where 0 indicates no pain and 10 is the maximum pain experienced.

  2. Disability [0 weeks, 12 weeks]

    The 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.

  3. Satisfaction scale with the treatment received [12 weeks]

    The 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.

  4. Sistem usability scale [12 weeks]

    It 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 David Hernández Guillén Valencia Spain 46010

Sponsors and Collaborators

  • University of Valencia

Investigators

  • Principal Investigator: David Hernández-Guillén, University of Valencia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Hernández-Guillén, University teacher, PT, PhD, University of Valencia
ClinicalTrials.gov Identifier:
NCT06070415
Other Study ID Numbers:
  • CHATBOT_LOW_BACK_PAIN
First Posted:
Oct 6, 2023
Last Update Posted:
Oct 11, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by David Hernández-Guillén, University teacher, PT, PhD, University of Valencia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2023