NCT05628428

Brief Summary

Due to the increased prevalence of neck pain in studied adolescents and young adults, this intervention is carried out, which mainly seeks to compare and verify the effectiveness of therapeutic exercise with education, compared to education alone. It is also necessary to mention the high levels of stress levels reported in students, which can affect the increase in pain and the perception of these at times when stress increases. The intervention has been decreed in the weeks before and during the exam period at the University of Valencia, to see if the neck pain experienced by students at similar stages of their academic life is prevented or reduced. It is decided to use education above all to give the participants a tool that allows the participants to find out what happens and why it happens when the participants suffer from neck pain, as well as an explanation of the pathology and the risk factors and how to avoid -the bear. In addition, knowledge about the condition in question can lead to a reconceptualization of pain, changing the approach and exposing a different approach, when treating the pathology. It must be said that in the structure and layout of the informative document, the investigators think of an instrument that can serve the participants for the future. Another reason for carrying out the study is the few tests on neck pain carried out with new technologies. The use of videos, therefore, seeks to facilitate access to the information provided, being a useful and practical tool for students, familiar with the use of new technologies. In addition, the training is intended to be as didactic as possible, the chosen exercises are carefully explained and the fact that they are found in videos and not in a practical class, favors access to the content in these, for that the participants use the videos at their disposal. Finally, treating neck pain with training and education and taking into account the stress of students, brings to conventional treatment an interesting perspective of coping, focused on the biopsychosocial field.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 28, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

November 15, 2022

Last Update Submit

July 18, 2023

Conditions

Keywords

Video pillsExerciseNeck pain

Outcome Measures

Primary Outcomes (3)

  • Visual Analogue Scale (VAS)

    Scale that evaluates pain from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.

    0 week (baseline)

  • Visual Analogue Scale (VAS)

    Scale that evaluates pain from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.

    4 week (middle)

  • Visual Analogue Scale (VAS)

    Scale that evaluates pain from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.

    8 week (post intervention)

Secondary Outcomes (3)

  • SISCO Inventory of Academic Stress

    0 week (baseline), 4 week, 8 week (post intervention)

  • Neck Disability Index

    0 week (baseline), 4 week, 8 week (post intervention)

  • EQ-5D-5L Quality of Life Questionnaire

    0 week (baseline), 4 week, 8 week (post intervention)

Study Arms (2)

Exercise

EXPERIMENTAL

Exercising through educational videos for eight weeks. In addition, they will receive educational information about neck pain and the importance of exercise in this case, at the beginning of the study.

Other: Exercise to strengthen neck area.Other: Information

Control

ACTIVE COMPARATOR

Educational information about neck pain and the importance of exercise in this case, at the beginning of the study.

Other: Information

Interventions

An exercise protocol will be carried out through educational videos. There will be a total of four videos which will pose exercises for two weeks each. These exercises will be done twice a week. A reminder will be sent by email on the days that they must be carried out.

Exercise

Information will be provided on neck pain and how exercise is able to help prevent it.

ControlExercise

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Students of first curse of physiotherapy.
  • That they have had an episode of neck pain at exam time.

You may not qualify if:

  • They do not want to sign the informed consent.
  • That they present some pathology that causes chronic cervical pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physiotherapy of the University of Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Neck PainMotor Activity

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • David Hernández-Guillén, PT, PhD

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
A researcher unrelated to the intervention will be responsible for randomizing the sample between the two groups. The researchers in charge of evaluating and interpreting the data will not know to which group each participant belongs.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Ramdomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor, PT, PhD

Study Record Dates

First Submitted

November 15, 2022

First Posted

November 28, 2022

Study Start

December 1, 2022

Primary Completion

April 30, 2023

Study Completion

May 31, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations