Back to resultsAdherence to Exercises for Neck Pain.
Primary Purpose
Treatment Adherence and Compliance
Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Education
Chatbot
Home exercise, usual care
Sponsored by
About this trial
This is an interventional other trial for Treatment Adherence and Compliance focused on measuring Treatment adherence, New technologies, Back pain
Eligibility Criteria
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
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 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).
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
NCT06070441
First Posted
September 29, 2023
Last Updated
October 8, 2023
Sponsor
University of Valencia
1. Study Identification
Unique Protocol Identification Number
NCT06070441
Brief Title
Adherence to Exercises for Neck Pain.
Official Title
Adherence to Home Treatment of Patients With Neck Pain Through the Use of Information and Communication Technologies.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 10, 2023 (Anticipated)
Primary Completion Date
July 10, 2024 (Anticipated)
Study Completion Date
August 10, 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Adherence and Compliance
Keywords
Treatment adherence, New technologies, Back 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 intervention
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
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
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
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 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).
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Hernández-Guillén
Phone
+34963983853
Ext
51232
Email
david.hernandez@uv.es
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 Neck Pain.
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