- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05628428
Effects of Exercise on Cervical Pain Through Educational Videos
Effects of an Exercise Program on Cervical Pain Through Educational Videos: a Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Valencia, Spain, 46010
- Faculty of Physiotherapy of the University of Valencia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise
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.
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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.
Information will be provided on neck pain and how exercise is able to help prevent it.
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Active Comparator: Control
Educational information about neck pain and the importance of exercise in this case, at the beginning of the study.
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Information will be provided on neck pain and how exercise is able to help prevent it.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale (VAS)
Time Frame: 0 week (baseline)
|
Scale that evaluates pain from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.
|
0 week (baseline)
|
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Visual Analogue Scale (VAS)
Time Frame: 4 week (middle)
|
Scale that evaluates pain from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.
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4 week (middle)
|
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Visual Analogue Scale (VAS)
Time Frame: 8 week (post intervention)
|
Scale that evaluates pain from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.
|
8 week (post intervention)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SISCO Inventory of Academic Stress
Time Frame: 0 week (baseline), 4 week, 8 week (post intervention)
|
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). |
0 week (baseline), 4 week, 8 week (post intervention)
|
|
Neck Disability Index
Time Frame: 0 week (baseline), 4 week, 8 week (post intervention)
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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.
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0 week (baseline), 4 week, 8 week (post intervention)
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EQ-5D-5L Quality of Life Questionnaire
Time Frame: 0 week (baseline), 4 week, 8 week (post intervention)
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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.
|
0 week (baseline), 4 week, 8 week (post intervention)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Hernández-Guillén, PT, PhD, University of Valencia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EX_ONLINE_01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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