Chronic Neck PainNCT04125901
Pain Neuroscience Education and Exercise in High School Students With Chronic Idiopathic Neck Pain
A study testing Pain Neuroscience Education and Exercise and Exercise in people with Chronic Neck Pain, run by Aveiro University at 3 sites in Portugal.
Trial summary
Musculoskeletal pain can affect up to 40% of children and adolescents. Neck pain (NP) is one of the most prevalent painful conditions and evidence suggests that its prevalence has increased in recent decades in adolescents aged 16 to 18 years, from 22.9% in 1991 to 29.5% in 2011. Read more about this study
- Who is it for?
- Ages 13 to 20 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Pain Neuroscience Education and Exercise and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 3 sitesPortugal
- Study dates
- 1 Oct 2019to 30 Nov 2020
- 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 13 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Students with chronic and idiopathic NP for at least 3 months
- Have a pain intensity of NPS greater than or equal to 2
- Not receiving any treatment for NP (except analgesic)
Who cannot join
- All students with nervous or rheumatic system pathology
- Students attending special education (because they may need more accompaniment which, in this group intervention, will not be possible)
Trial locations and contacts
3 sites in 1 country.
Portugal3 sites
Adolfo Portela High School
Aveiro
Dr. Jaime Magalhães Lima High School
Aveiro
José Estevão High School
Aveiro
About this study
Official title: Chronic Idiopathic Neck Pain in High School Students: Effectiveness of an Intervention Based on Exercise and Pain Neuroscience Education
Musculoskeletal pain can affect up to 40% of children and adolescents. Neck pain (NP) is one of the most prevalent painful conditions and evidence suggests that its prevalence has increased in recent decades in adolescents aged 16 to 18 years, from 22.9% in 1991 to 29.5% in 2011. Interventions based on pain neuroscience education have emerged as promising strategies in chronic pain conditions.In adults this intervention has been explored in many pain conditions, including musculoskeletal pain, but there is only one pilot study in adolescents with chronic NP and one case study in adolescents with fibromyalgia.
Thus, the main objective of the present study is:
Read more
(i) To compare the effectiveness of an education program based on pain neuroscience education and exercise versus exercise alone, in decreasing pain intensity in secondary school students with chronic and idiopathic NP immediately after the intervention and at 6 months.
The secondary objectives are to:
- Compare the effectiveness of these programs immediately after the intervention and at 6 months in i) disability, ii) sleep, iii) pain catastrophizing, iv) fear of movement, v) self-efficacy, vi) central sensitization vii) the strength of the deep neck flexors and extensors muscles and stabilizers of the scapula; and viii) the pressure pain threshold between the two intervention groups; ii) Explore possible predictors of response to treatment.
Read the detailed description
It is anticipated that the sample will consist of 127 participants from four secondary schools that will be divided into two groups. Both groups will receive the same exercise-based intervention. The experimental group will receive, in addition to exercise, an intervention based on pain neuroscience education. The intervention will consist of 1 session per week during 8 weeks and will be applied in small groups.
The intervention will be performed in a blended-learning format. Five sessions will be face-to-face with up to 45 minutes duration, performed at school and incorporated into physical education classes and 3 will be performed at home, supported by vídeos sent by WhatsApp. The first two sessions will always be face-to-face. Face-to-face sessions will be interspersed with WhatsApp sessions.
Participants will be assessed, by online questionnaires, for sociodemographic aspects, pain characterization and physical activity level, disability, sleep, catastrophizing, fear of movement, self-efficacy, central sensitization and knowledge on pain neurophysiology. In addition, 3 muscle tests will be performed for the deep neck flexor and extensor muscles and scapular stabilizers, and the pressure pain thresholds in the neck and at distance will be assessed.
- Conditions
- Chronic Neck Pain
- Being tested
- Pain Neuroscience Education and Exercise, Exercise
- Keywords
- Chronic Neck Pain, Adolescents, Pain Neuroscience Education, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience Education and ExerciseOther
The incorporation of the exercise in this group will be gradual, in order to decrease the education component and increase the exercise component (up to 45/60 minutes). The 1st session will be only PNE and will last approximately 45 minutes. In the 2nd session, there will be 30 minutes of PNE and the remaining 15 minutes of exercise. In the following 4th and 6th sessions, 15 minutes of each session will be used to clarify doubts and emphasize PNE concepts and strategies. The 8th session will include exercises only. In WhatsApp sessions, in addition to the video with the exercises, participants will receive activities about the PNE.
ExerciseOther
The exercise group will perform exercises in all sessions (45 minutes of exercise in face-to-face sessions). In WhatsApp sessions, participants will receive a video with exercises to perform at home.
| Study group | Role | What they receive |
|---|---|---|
| Pain Neuroscience Education and Exercise | Experimental | Participants will received an 8-week intervention consisting of exercise and pain neuroscience education. Pain neuroscience education will be conducted in line with international guidelines and will address the following topics: pain neurophysiology, nociception and nociceptive pathways, inhibition and spinal cord stimulation, peripheral and central sensitization, nervous system plasticity and the impact of variables such as stress, anxiety, sleep and exercise on pain behavior. Exercise will be performed in accordance with international guidelines for chronic NP. Motor control, endurance and strengthening exercises will be performed for the neck and scapulo-thoracic region. Receives: Other: Pain Neuroscience Education and Exercise |
| Exercise | Other | Participants will received an 8-week intervention consisting of exercise. The exercise performed in this group will be the same as in the intervention group and will follow the same international guidelines for chronic NP. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain
Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)
Measured: Baseline
Intensity of pain
Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)
Measured: 8 weeks
Intensity of pain
Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)
Measured: 6 months
Secondary outcomes (42)
Pain location
Assessed using a body chart where the patients identifies the painful body segments
Measured: Baseline
Pain location
Assessed using a body chart where the patients identifies the painful body segments
Measured: 8 weeks
Pain location
Assessed using a body chart where the patients identifies the painful body segments
Measured: 6 months
Pain frequency
Assessed using a closed question about pain frequency in the last week. (How many times in the last week have you felt this pain?". The answer options are: Never, rarely (once a week) occasionally (2 to 3 times a week), often (more than 3 times a week) and always.
Measured: Baseline
Pain frequency
Assessed using a closed question about neck pain frequency in the last week (How many times in the last week have you felt this pain?". The answer options are: Never, rarely (once a week) occasionally (2 to 3 times a week), often (more than 3 times a week) and always.
Measured: 8 weeks
Pain frequency
Assessed using a closed question about neck pain frequency in the last week (How many times in the last week have you felt this pain?". The answer options are: Never, rarely (once a week) occasionally (2 to 3 times a week), often (more than 3 times a week) and always.
Measured: 6 months
Physical activity
Assessed using two questions regarding moderate or vigorous physical activity during the week ("In addition to your physical education classes, did you perform any other moderate physical activity?" and "In addition to your physical education classes, did you perform any other vigorous physical activity?") adapted by Silva et al. 2017.
Measured: Baseline
Physical activity
Assessed using two questions regarding moderate or vigorous physical activity during the week ("In addition to your physical education classes, did you perform any other moderate physical activity?" and "In addition to your physical education classes, did you perform any other vigorous physical activity?") adapted by Silva et al. 2017.
Measured: 8 weeks
Physical activity
Assessed using two questions regarding moderate or vigorous physical activity during the week ("In addition to your physical education classes, did you perform any other moderate physical activity?" and "In addition to your physical education classes, did you perform any other vigorous physical activity?") adapted by Silva et al. 2017.
Measured: 6 months
Disability
Assessed using the Functional Disability Inventory (Total score range from 0-60 and higher scores are indicative of greater pain-related disability)
Measured: Baseline
Disability
Assessed using the Functional Disability Inventory (Total score range from 0-60 and higher scores are indicative of greater pain-related disability)
Measured: 8 weeks
Disability
Assessed using the Functional Disability Inventory (Total score range from 0-60 and higher scores are indicative of greater pain-related disability)
Measured: 6 months
Sleep
Assessed using the Basic Scale of Symptoms of Insomnia and Sleep Quality (Total score range from 0-28 and higher scores are indicative of poorer sleep quality)
Measured: Baseline
Sleep
Assessed using the Basic Scale of Symptoms of Insomnia and Sleep Quality (Total score range from 0-28 and higher scores are indicative of poorer sleep quality)
Measured: 8 weeks
Sleep
Assessed using the Basic Scale of Symptoms of Insomnia and Sleep Quality (Total score range from 0-28 and higher scores are indicative of poorer sleep quality)
Measured: 6 months
Pain catastrophizing
Assessed using the Pain Catastrophizing Scale (Total score range from 0-52 and higher values are indicative of higher pain catastrophizing)
Measured: Baseline
Pain catastrophizing
Assessed using the Pain Catastrophizing Scale (Total score range from 0-52 and higher values are indicative of higher pain catastrophizing)
Measured: 8 weeks
Pain catastrophizing
Assessed using the Pain Catastrophizing Scale (Total score range from 0-52 and higher values are indicative of higher pain catastrophizing)
Measured: 6 months
Fear of movement
Assessed using the Tampa Scale of Kinesiophobia (Total score range from 13-52 and higher values are indicative of higher levels of fear of movement)
Measured: Baseline
Fear of movement
Assessed using the Tampa Scale of Kinesiophobia (Total score range from 13-52 and higher values are indicative of higher levels of fear of movement)
Measured: 8 weeks
Fear of movement
Assessed using the Tampa Scale of Kinesiophobia (Total score range from 13-52 and higher values are indicative of higher levels of fear of movement)
Measured: 6 months
Self-efficacy
Assessed using the Self-Efficacy Pain Scale (Total score range from 7 to 35 points and lower scores are indicate of greater self-efficacy)
Measured: Baseline
Self-efficacy
Assessed using the Self-Efficacy Pain Scale (Total score range from 7 to 35 points and lower scores are indicate of greater self-efficacy)
Measured: 8 weeks
Self-efficacy
Assessed using the Self-Efficacy Pain Scale (Total score range from 7 to 35 points and lower scores are indicate of greater self-efficacy)
Measured: 6 months
Central Sensitization
Assessed using the Central Sensitization Inventory (Total score range from 0 to 100 and higher scores are indicative of a higher degree of symptomatology associated with central sensitization)
Measured: Baseline
Central Sensitization
Assessed using the Central Sensitization Inventory (Total score range from 0 to 100 and higher scores are indicative of a higher degree of symptomatology associated with central sensitization)
Measured: 8 weeks
Central Sensitization
Assessed using the Central Sensitization Inventory (Total score range from 0 to 100 and higher scores are indicative of a higher degree of symptomatology associated with central sensitization)
Measured: 6 months
Knowledge of pain neuroscience
Assessed using the Pain Neurophysiology Questionnaire (Total score range from 0-19 and higher values are indicative of more knowledge on pain neurophysiology)
Measured: Baseline
Knowledge of pain neuroscience
Assessed using the Pain Neurophysiology Questionnaire (Total score range from 0-19 and higher values are indicative of more knowledge on pain neurophysiology)
Measured: 8 weeks
Knowledge of pain neuroscience
Assessed using the Pain Neurophysiology Questionnaire (Total score range from 0-19 and higher values are indicative of more knowledge on pain neurophysiology)
Measured: 6 months
Muscular resistance of the deep flexor muscles of the cervical
Assessed using the Deep Neck Flexor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Measured: Baseline
Muscular resistance of the deep flexor muscles of the cervical
Assessed using the Deep Neck Flexor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Measured: 8 weeks
Muscular resistance of the deep flexor muscles of the cervical
Assessed using the Deep Neck Flexor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Measured: 6 months
Muscular endurance of the deep cervical extensor muscles
Assessed using the Cervical Extensor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Measured: Baseline
Muscular endurance of the deep cervical extensor muscles
Assessed using the Cervical Extensor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Measured: 8 weeks
Muscular endurance of the deep cervical extensor muscles
Assessed using the Cervical Extensor Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Measured: 6 months
Muscular resistance of the stabilizing muscles of the scapular girdle
Assessed using the Scapular Muscle Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Measured: Baseline
Muscular resistance of the stabilizing muscles of the scapular girdle
Assessed using the Scapular Muscle Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Measured: 8 weeks
Muscular resistance of the stabilizing muscles of the scapular girdle
Assessed using the Scapular Muscle Endurance Test (the time, in seconds, that each participant will performed the test position will be recorded)
Measured: 6 months
Pressure Pain Threshold
Assessed using the algometer (the point of minimum pressure that induces a pain sensation will be recorded)
Measured: Baseline
Pressure Pain Threshold
Assessed using the algometer (the point of minimum pressure that induces a pain sensation will be recorded)
Measured: 8 weeks
Pressure Pain Threshold
Assessed using the algometer (the point of minimum pressure that induces a pain sensation will be recorded)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start1 Oct 2019
- Primary completion30 Jun 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Science and Technology, Portugal
- Responsible party
- Principal investigator, Rosa Andias, Aveiro University
- Investigators
- Rosa Andias, MD, Principal investigator, University of Aveiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125901
- Sponsor's protocol ID
- 24092019
- Status last verified
- Feb 2021
- First submitted
- 1 Oct 2019
- Last updated
- 23 Feb 2021
- Results posted
- 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 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Idiopathic Neck Pain in High School Students: Effectiveness of an Intervention Based on Exercise and Pain Neuroscience Education
- ClinicalTrials.gov ID
- NCT04125901
- Acronym / sponsor ID
- 24092019
- Conditions
- Chronic Neck Pain
- Keywords
- Chronic Neck Pain, Adolescents, Pain Neuroscience Education, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Collaborators
- Foundation for Science and Technology, Portugal
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 14 Oct 2019 (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.
Musculoskeletal pain can affect up to 40% of children and adolescents. Neck pain (NP) is one of the most prevalent painful conditions and evidence suggests that its prevalence has increased in recent decades in adolescents aged 16 to 18 years, from 22.9% in 1991 to 29.5% in 2011. Interventions based on pain neuroscience education have emerged as promising strategies in chronic pain conditions.In adults this intervention has been explored in many pain conditions, including musculoskeletal pain, but there is only one pilot study in adolescents with chronic NP and one case study in adolescents with fibromyalgia.
Thus, the main objective of the present study is:
(i) To compare the effectiveness of an education program based on pain neuroscience education and exercise versus exercise alone, in decreasing pain intensity in secondary school students with chronic and idiopathic NP immediately after the intervention and at 6 months.
The secondary objectives are to:
- Compare the effectiveness of these programs immediately after the intervention and at 6 months in i) disability, ii) sleep, iii) pain catastrophizing, iv) fear of movement, v) self-efficacy, vi) central sensitization vii) the strength of the deep neck flexors and extensors muscles and stabilizers of the scapula; and viii) the pressure pain threshold between the two intervention groups; ii) Explore possible predictors of response to treatment.
Detailed description
It is anticipated that the sample will consist of 127 participants from four secondary schools that will be divided into two groups. Both groups will receive the same exercise-based intervention. The experimental group will receive, in addition to exercise, an intervention based on pain neuroscience education. The intervention will consist of 1 session per week during 8 weeks and will be applied in small groups.
The intervention will be performed in a blended-learning format. Five sessions will be face-to-face with up to 45 minutes duration, performed at school and incorporated into physical education classes and 3 will be performed at home, supported by vídeos sent by WhatsApp. The first two sessions will always be face-to-face. Face-to-face sessions will be interspersed with WhatsApp sessions.
Participants will be assessed, by online questionnaires, for sociodemographic aspects, pain characterization and physical activity level, disability, sleep, catastrophizing, fear of movement, self-efficacy, central sensitization and knowledge on pain neurophysiology. In addition, 3 muscle tests will be performed for the deep neck flexor and extensor muscles and scapular stabilizers, and the pressure pain thresholds in the neck and at distance will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Neuroscience Education and Exercise | Experimental | Other: Pain Neuroscience Education and ExerciseParticipants will received an 8-week intervention consisting of exercise and pain neuroscience education. Pain neuroscience education will be conducted in line with international guidelines and will address the following topics: pain neurophysiology, nociception and nociceptive pathways, inhibition and spinal cord stimulation, peripheral and central sensitization, nervous system plasticity and the impact of variables such as stress, anxiety, sleep and exercise on pain behavior. Exercise will be performed in accordance with international guidelines for chronic NP. Motor control, endurance and strengthening exercises will be performed for the neck and scapulo-thoracic region. |
| Exercise | Other | Other: ExerciseParticipants will received an 8-week intervention consisting of exercise. The exercise performed in this group will be the same as in the intervention group and will follow the same international guidelines for chronic NP. |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Students with chronic and idiopathic NP for at least 3 months
- Have a pain intensity of NPS greater than or equal to 2
- Not receiving any treatment for NP (except analgesic)
Key exclusion criteria (2 listed)
- All students with nervous or rheumatic system pathology
- Students attending special education (because they may need more accompaniment which, in this group intervention, will not be possible)
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 |
|---|---|---|
| Pain Neuroscience Education and ExerciseThe incorporation of the exercise in this group will be gradual, in order to decrease the education component and increase the exercise component (up to 45/60 minutes). The 1st session will be only PNE and will last approximately 45 minutes. In the 2nd session, there will be 30 minutes of PNE and the remaining 15 minutes of exercise. In the following 4th and 6th sessions, 15 minutes of each session will be used to clarify doubts and emphasize PNE concepts and strategies. The 8th session will include exercises only. In WhatsApp sessions, in addition to the video with the exercises, participants will receive activities about the PNE. | Other | Pain Neuroscience Education and Exercise |
| ExerciseThe exercise group will perform exercises in all sessions (45 minutes of exercise in face-to-face sessions). In WhatsApp sessions, participants will receive a video with exercises to perform at home. | Other | Exercise |
Primary outcome
Intensity of pain
Time frame: Baseline
Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)
Intensity of pain
Time frame: 8 weeks
Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)
Intensity of pain
Time frame: 6 months
Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)
42 secondary outcomes
Pain location
Time frame: Baseline
Pain location
Time frame: 8 weeks
Pain location
Time frame: 6 months
Pain frequency
Time frame: Baseline
Pain frequency
Time frame: 8 weeks
Pain frequency
Time frame: 6 months
Physical activity
Time frame: Baseline
Physical activity
Time frame: 8 weeks
Physical activity
Time frame: 6 months
Disability
Time frame: Baseline
Disability
Time frame: 8 weeks
Disability
Time frame: 6 months
Sleep
Time frame: Baseline
Sleep
Time frame: 8 weeks
Sleep
Time frame: 6 months
Pain catastrophizing
Time frame: Baseline
Pain catastrophizing
Time frame: 8 weeks
Pain catastrophizing
Time frame: 6 months
Fear of movement
Time frame: Baseline
Fear of movement
Time frame: 8 weeks
Fear of movement
Time frame: 6 months
Self-efficacy
Time frame: Baseline
Self-efficacy
Time frame: 8 weeks
Self-efficacy
Time frame: 6 months
Central Sensitization
Time frame: Baseline
Central Sensitization
Time frame: 8 weeks
Central Sensitization
Time frame: 6 months
Knowledge of pain neuroscience
Time frame: Baseline
Knowledge of pain neuroscience
Time frame: 8 weeks
Knowledge of pain neuroscience
Time frame: 6 months
Muscular resistance of the deep flexor muscles of the cervical
Time frame: Baseline
Muscular resistance of the deep flexor muscles of the cervical
Time frame: 8 weeks
Muscular resistance of the deep flexor muscles of the cervical
Time frame: 6 months
Muscular endurance of the deep cervical extensor muscles
Time frame: Baseline
Muscular endurance of the deep cervical extensor muscles
Time frame: 8 weeks
Muscular endurance of the deep cervical extensor muscles
Time frame: 6 months
Muscular resistance of the stabilizing muscles of the scapular girdle
Time frame: Baseline
Muscular resistance of the stabilizing muscles of the scapular girdle
Time frame: 8 weeks
Muscular resistance of the stabilizing muscles of the scapular girdle
Time frame: 6 months
Pressure Pain Threshold
Time frame: Baseline
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 23 Feb 2021.
- 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.
Rosa Andias, MD principal investigator
University of Aveiro
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education and Exercise and Exercise in people with Chronic Neck Pain, run by Aveiro University at 3 sites in Portugal.
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 3 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 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal. 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?
Intensity of pain (time frame: 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 23 Feb 2021.