Neck PainNCT05628428
Effects of Exercise on Cervical Pain Through Educational Videos
A study testing Exercise to strengthen neck area. and Information in people with Neck Pain, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Exercise to strengthen neck area. and Information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Students of first curse of physiotherapy.
- That they have had an episode of neck pain at exam time.
Who cannot join
- They do not want to sign the informed consent.
- That they present some pathology that causes chronic cervical pain.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Physiotherapy of the University of Valencia
Valencia, 46010
About this study
Official title: 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.
Read more
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.
- Conditions
- Neck Pain
- Being tested
- Exercise to strengthen neck area., Information
- Keywords
- Video pills, Exercise, Neck pain
- Medical subject headings
- Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise to strengthen neck area.Other
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.
InformationOther
Information will be provided on neck pain and how exercise is able to help prevent it.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
Scale that evaluates pain from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.
Measured: 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.
Measured: 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.
Measured: 8 week (post intervention)
Secondary outcomes (3)
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).
Measured: 0 week (baseline), 4 week, 8 week (post intervention)
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.
Measured: 0 week (baseline), 4 week, 8 week (post intervention)
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.
Measured: 0 week (baseline), 4 week, 8 week (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start1 Dec 2022
- Primary completion30 Apr 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Ramdomized clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Hernández-Guillén, University of Valencia
- Investigators
- David Hernández-Guillén, PT, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628428
- Sponsor's protocol ID
- EX_ONLINE_01
- Status last verified
- Jul 2023
- First submitted
- 15 Nov 2022
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Exercise Program on Cervical Pain Through Educational Videos: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05628428
- Acronym / sponsor ID
- EX_ONLINE_01
- Conditions
- Neck Pain
- Keywords
- Video pills, Exercise, Neck pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 28 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Ramdomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Exercise to strengthen neck area., Other: InformationExercising 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. |
| Control | Active comparator | Other: InformationEducational information about neck pain and the importance of exercise in this case, at the beginning of the study. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Students of first curse of physiotherapy.
- That they have had an episode of neck pain at exam time.
Key exclusion criteria (2 listed)
- They do not want to sign the informed consent.
- That they present some pathology that causes chronic cervical pain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise to strengthen neck area.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. | Other | Exercise |
| InformationInformation will be provided on neck pain and how exercise is able to help prevent it. | Other | Control, Exercise |
Primary outcome
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.
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.
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.
3 secondary outcomes
SISCO Inventory of Academic Stress
Time frame: 0 week (baseline), 4 week, 8 week (post intervention)
Neck Disability Index
Time frame: 0 week (baseline), 4 week, 8 week (post intervention)
EQ-5D-5L Quality of Life Questionnaire
Time frame: 0 week (baseline), 4 week, 8 week (post intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hernández-Guillén, PT, PhD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise to strengthen neck area. and Information in people with Neck Pain, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: 0 week (baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.