Adherence to Exercises for Low Back Pain.

NCT06070415 | Completed

• 1 other identifier: CHATBOT_LOW_BACK_PAIN
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment Adherence; Treatment Compliance

Keywords

Treatment adherence; New technologies; Lowback pain

Outcome Measures

Primary Outcomes (1)

• Adherence

  Record of the number of sessions performed.

  0 weeks, 12 weeks

Secondary Outcomes (4)

• Visual analogue scale (VAS)

  0 weeks, 12 weeks

• Disability

  0 weeks, 12 weeks

• Satisfaction scale with the treatment received

  12 weeks

• Sistem usability scale

  12 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Home exercise assisted with a chatbot

Device: Chatbot; Other: Education

Control

ACTIVE COMPARATOR

Home exercise, usual care

Other: Home exercise, usual care; Other: Education

Interventions

Chatbot 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

Experimental

Home exercise, usual care OTHER

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

Control

Education OTHER

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

Control; Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

David Hernández Guillén

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance; Patient Compliance

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Patient Acceptance of Health Care

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• David Hernández-Guillén

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The interventor providing the education sessions will be blinded to group allocation The outcome assessor will be blinded to the interventions
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University teacher, PT, PhD

Model Details: Two arms study, experimental vs control

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 6, 2023
• Study Start: September 20, 2023
• Primary Completion: May 20, 2024
• Study Completion: June 20, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)