Adherence to Exercises for Low Back Pain.
Primary Purpose
Treatment Adherence, Treatment Compliance
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Chatbot
Home exercise, usual care
Education
Sponsored by
About this trial
This is an interventional other trial for Treatment Adherence focused on measuring Treatment adherence, New technologies, Lowback pain
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
Sites / Locations
- David Hernández Guillén
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Control
Arm Description
Home exercise assisted with a chatbot
Home exercise, usual care
Outcomes
Primary Outcome Measures
Adherence
Record of the number of sessions performed.
Secondary Outcome Measures
Visual analogue scale (VAS)
Numerical scale from 0 to 10, where 0 indicates no pain and 10 is the maximum pain experienced.
Disability
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.
Satisfaction scale with the treatment received
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.
Sistem usability scale
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
Full Information
NCT ID
NCT06070415
First Posted
September 29, 2023
Last Updated
October 8, 2023
Sponsor
University of Valencia
1. Study Identification
Unique Protocol Identification Number
NCT06070415
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 20, 2023 (Actual)
Primary Completion Date
May 20, 2024 (Anticipated)
Study Completion Date
June 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Adherence, Treatment Compliance
Keywords
Treatment adherence, New technologies, Lowback pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two arms study, experimental vs control
Masking
Care ProviderOutcomes Assessor
Masking Description
The interventor providing the education sessions will be blinded to group allocation The outcome assessor will be blinded to the interventions
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Home exercise assisted with a chatbot
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Home exercise, usual care
Intervention Type
Device
Intervention Name(s)
Chatbot
Intervention Description
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
Other
Intervention Name(s)
Home exercise, usual care
Intervention Description
12 week- intervention. Printed sheets indicating how to exercises and how many repetitions to perform
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
One-week, three sessions in alternate days, outpatient supervised education on how to perform the exercises at home
Primary Outcome Measure Information:
Title
Adherence
Description
Record of the number of sessions performed.
Time Frame
0 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Visual analogue scale (VAS)
Description
Numerical scale from 0 to 10, where 0 indicates no pain and 10 is the maximum pain experienced.
Time Frame
0 weeks, 12 weeks
Title
Disability
Description
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.
Time Frame
0 weeks, 12 weeks
Title
Satisfaction scale with the treatment received
Description
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.
Time Frame
12 weeks
Title
Sistem usability scale
Description
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
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hernández-Guillén
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
David Hernández Guillén
City
Valencia
ZIP/Postal Code
46010
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Adherence to Exercises for Low Back Pain.
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