Adherence to Exercises for Neck Pain.

Treatment Adherence and Compliance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06070441
• Other study ID #: CHATBOT_NECK_PAIN
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2023
• Est. completion date: August 10, 2024

Study information

• Verified date: January 2024
• Source: University of Valencia
• Contact: David Hernández-Guillén
• Phone: +34963983853
• Email: david.hernandez[@]uv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project continuing to study on the effectiveness of a Chatbot in promoting adherence to home physiotherapy treatment for patients, in this case, with cervical musculoskeletal injuries and pain. The use of digital technologies and media is 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 10, 2024
• Est. primary completion date: July 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years.

• Diagnosis of cervical 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

Related Conditions & MeSH terms

• Neck Pain
• Treatment Adherence and Compliance

Intervention

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

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

Locations

Country	Name	City	State
Spain	David Hernández Guillén	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	Record of the number of sessions performed.	0 weeks, 12 weeks
Secondary	Visual analogue scale (VAS)	Numerical scale from 0 to 10, where 0 indicates no pain and 10 is the maximum pain experienced.	0 weeks, 12 weeks
Secondary	Disability	The Neck Disability Index (NDI) consists of ten questions in the following domains: Pain Intensity, Personal Care, Lifting, Reading, Headaches, Concentration, Work, Driving, Sleeping, and Recreation. Scoring: Each question contains six answer choices, scored from 0 (no disability) to 5 (complete disability).	0 weeks, 12 weeks
Secondary	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.	12 weeks
Secondary	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	12 weeks