Effects of Exercise on Cervical Pain Through Educational Videos
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise to strengthen neck area.
Information
Sponsored by
About this trial
This is an interventional prevention trial for Neck Pain focused on measuring Video pills, Exercise, Neck pain
Eligibility Criteria
Inclusion Criteria: Students of first curse of physiotherapy. That they have had an episode of neck pain at exam time. Exclusion Criteria: They do not want to sign the informed consent. That they present some pathology that causes chronic cervical pain.
Sites / Locations
- Faculty of Physiotherapy of the University of Valencia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise
Control
Arm Description
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.
Educational information about neck pain and the importance of exercise in this case, at the beginning of the study.
Outcomes
Primary Outcome Measures
Visual Analogue Scale (VAS)
Scale that evaluates pain from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.
Visual Analogue Scale (VAS)
Scale that evaluates pain from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.
Visual Analogue Scale (VAS)
Scale that evaluates pain from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.
Secondary Outcome Measures
SISCO Inventory of Academic Stress
The SISCO Inventory is a measure of academic stress in students of upper education or postgraduates. Consists of 31 items including three broad factors: Stressors, Symptoms and Coping. The first item is intended to filter which respondents are suitable candidates to answer the questionnaire. The subsequent item measures the perceived intensity of academic stress. Stressors (first factor, 8 items) represent the frequency in which the demands of the environment are valued as stressors; Symptoms (second factor, 15 items) indicate the frequency in which the symptoms are presented; and Coping (third factor, 6 items), identify the frequency of coping strategies.
Responses are provided on a 5-point Likert type scale anchored by 1 (never) to 5 (always).
Neck Disability Index
This questionnaire has been designed to give the doctor information as to how your neck pain has affected your ability to manage in everyday life. Questions are scored on a vertical scale of 0-5. Total scores and multiply by 2. Divide by number of sections answered multiplied by 10. A score of 22% or more is considered a significant activities of daily living disability.
EQ-5D-5L Quality of Life Questionnaire
This scale is divided into 5 items with 5 options each, which go from best to worst (1 best, 5 worst). In addition, a rule is used to assess health that goes from 0 to 100, where 0 is the worst possible health and 100 is the best possible health.
Full Information
NCT ID
NCT05628428
First Posted
November 15, 2022
Last Updated
July 18, 2023
Sponsor
University of Valencia
1. Study Identification
Unique Protocol Identification Number
NCT05628428
Brief Title
Effects of Exercise on Cervical Pain Through Educational Videos
Official Title
Effects of an Exercise Program on Cervical Pain Through Educational Videos: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Video pills, Exercise, Neck pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Ramdomized clinical trial
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Educational information about neck pain and the importance of exercise in this case, at the beginning of the study.
Intervention Type
Other
Intervention Name(s)
Exercise to strengthen neck area.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Information
Intervention Description
Information will be provided on neck pain and how exercise is able to help prevent it.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
Scale that evaluates pain from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.
Time Frame
0 week (baseline)
Title
Visual Analogue Scale (VAS)
Description
Scale that evaluates pain from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.
Time Frame
4 week (middle)
Title
Visual Analogue Scale (VAS)
Description
Scale that evaluates pain from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.
Time Frame
8 week (post intervention)
Secondary Outcome Measure Information:
Title
SISCO Inventory of Academic Stress
Description
The SISCO Inventory is a measure of academic stress in students of upper education or postgraduates. Consists of 31 items including three broad factors: Stressors, Symptoms and Coping. The first item is intended to filter which respondents are suitable candidates to answer the questionnaire. The subsequent item measures the perceived intensity of academic stress. Stressors (first factor, 8 items) represent the frequency in which the demands of the environment are valued as stressors; Symptoms (second factor, 15 items) indicate the frequency in which the symptoms are presented; and Coping (third factor, 6 items), identify the frequency of coping strategies.
Responses are provided on a 5-point Likert type scale anchored by 1 (never) to 5 (always).
Time Frame
0 week (baseline), 4 week, 8 week (post intervention)
Title
Neck Disability Index
Description
This questionnaire has been designed to give the doctor information as to how your neck pain has affected your ability to manage in everyday life. Questions are scored on a vertical scale of 0-5. Total scores and multiply by 2. Divide by number of sections answered multiplied by 10. A score of 22% or more is considered a significant activities of daily living disability.
Time Frame
0 week (baseline), 4 week, 8 week (post intervention)
Title
EQ-5D-5L Quality of Life Questionnaire
Description
This scale is divided into 5 items with 5 options each, which go from best to worst (1 best, 5 worst). In addition, a rule is used to assess health that goes from 0 to 100, where 0 is the worst possible health and 100 is the best possible health.
Time Frame
0 week (baseline), 4 week, 8 week (post intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Students of first curse of physiotherapy.
That they have had an episode of neck pain at exam time.
Exclusion Criteria:
They do not want to sign the informed consent.
That they present some pathology that causes chronic cervical pain.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hernández-Guillén, PT, PhD
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physiotherapy of the University of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Exercise on Cervical Pain Through Educational Videos
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