Adherence to Exercises for Neck Pain.

Sponsor
University of Valencia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06070441
Collaborator
(none)
50
1
2
9
5.6

Study Details

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.

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

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 intervention
Primary Purpose:
Other
Official Title:
Adherence to Home Treatment of Patients With Neck Pain Through the Use of Information and Communication Technologies.
Anticipated Study Start Date :
Nov 10, 2023
Anticipated Primary Completion Date :
Jul 10, 2024
Anticipated Study Completion Date :
Aug 10, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental

Home exercise assisted with a chatbot

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

Active Comparator: Control

Home exercise, usual care

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

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

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 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).

  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 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

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:
NCT06070441
Other Study ID Numbers:
  • CHATBOT_NECK_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