PainNCT05645562
Pain Education Program in the Sport Population
A study testing Pain neuroscience education program and Self-care education program in people with Pain and Sports, run by University of the Balearic Islands at 1 site in Spain.
Trial summary
This study is designed to evaluate the effects of a pain neuroscience education program in pain perception, wellness and pain catastrophizing of youth athletes. For this, an experimental study with an intervention group (IG) and a control group (CG) is designed. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- What is being tested?
- Pain neuroscience education program and Self-care education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 3 Feb 2023to 12 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- to have at least 14 years old
- to have at least 2 years of experience in the sport
Who cannot join
- to have sustained an injury during the previous 6 months to start of the study
- to have sustained a surgery during the previous 12 months to start of the study
Trial locations and contacts
1 site in 1 country.
Spain1 site
Sport High Performance Center of Balearic Islands
Palma de Mallorca, Balearic Islands, 07009
About this study
Official title: Effects of the Pain Education Program in the Sport Population
This study is designed to evaluate the effects of a pain neuroscience education program in pain perception, wellness and pain catastrophizing of youth athletes. For this, an experimental study with an intervention group (IG) and a control group (CG) is designed. During 12 weeks of the 2022-2023 season, CG will receive a self-care education program, with information about health habits in the sport (rest, nutrition, body care and recovery). Meanwhile, IG will also receive a pain neuroscience education program, with information about biological, psychological and perceptual aspect of pain in the sports context. The study will be developed in the Sport High Performance Centre of Balearic Islands, from January to May. All athletes from this sports centre will be invited to participate in the study throughout an e-mail invitation from their sport regional federation. Prior to the beginning of the study, all participants will sign the inform consent. The Ethical Committee of the local university approved this study (280CER22). One week before intervention period, all athletes will be required to complete questionnaire about sociodemographic and sportive data (age, sex, and sport experience). Body mass and height will be also evaluated. Also, all the athletes will be required to complete three questionnaires about pain level, wellness and pain catastrophizing. Pain level and wellness will be evaluated prior to the start of the intervention and weekly, until finishing the intervention period. The pain catastrophizing level will be evaluated before and after the intervention period of the study. We hypothesized that those athletes who receive the pain neuroscience education program will increase wellness and decrease pain level and catastrophizing perception compared to those athletes who received a self-care educational program.
- Being tested
- Pain neuroscience education program, Self-care education program
- Keywords
- Pain education, Athlete, Pain catastrophizing
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain neuroscience education programBehavioural
- Types of pain (peripherical and central pain)
- Pain as information.
- Benign and harmful pain
- Psychological factors and pain in sport (Injuries, catastrophizing and pain)
Self-care education programBehavioural
- The importance of resting
- Nutritional habits
- Recovery techniques for athletes
- Principles of stretching, strengthening and endurance training
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group will receive a pain neuroscience education program (once time per month, during 4 months). This program will include information about biological, psychological and perceptual aspects of pain in the sport context. Receives: Behavioral: Pain neuroscience education program |
| Control group | Active comparator | The control group will receive a self-care education program (once time per month, during 4 months). This program will include information about health habits in the sport. Receives: Behavioral: Self-care education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wellness level
It is composed by seven questions about wellness, perceived effort, training volume. Wellness was assessed throughout four questions about the subjective perception of the quality of sleep, the amount of stress, the level of perceived fatigue, mood and perceived muscle damage. Each question is individually scored from 1 ("Very, very low, or very, very good") to 5 ("Very, very high, or very, very bad"), being 25 the maximal punctuation.
Measured: Change from baseline and between group differences in wellness during and after the intervention period of 12 weeks
Pain level
Pain intensity is assessed by using the Pain Visual Analog Scale (VAS, 0-10), ranging from 0 (no pain) to 10 (the worst imaginable pain). In case of pain existence, anatomical location, duration (days), sports practice affection (yes/no) were also collected
Measured: Change from baseline and between group differences in pain during and after the intervention period of 12 weeks
Pain catastrophizing level
It is designed to evaluate the catastrophizing level of athletes throughout the Pain Catastrophism Scale (PCS). The PCS assesses catastrophic level associated to pain experience through thirteen 4-points Likert items (from 0, not at all, to 4, all the time). Apart from global Catastrophism, PCS evaluates four subscales regarding rumination, helplessness, and magnification. The maximal score is 50 points.
Measured: Change from baseline and between group differences in pain catastrophizing after the intervention period of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start3 Feb 2023
- Primary completion3 Feb 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645562
- Sponsor's protocol ID
- 280CER22
- Status last verified
- Mar 2023
- First submitted
- 1 Dec 2022
- Last updated
- 21 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Sullivan K, O'Sullivan PB, Gabbett TJ. Pain and fatigue in sport: are they so different? Br J Sports Med. 2018 May;52(9):555-556. doi: 10.1136/bjsports-2017-098159. Epub 2017 Oct 19. No abstract available.
PubMed 29051168Vicente-Mampel J, Gargallo P, Bautista IJ, Blanco-Gimenez P, de Bernardo Tejedor N, Alonso-Martin M, Martinez-Soler M, Baraja-Vegas L. Impact of Pain Neuroscience Education Program in Community Physiotherapy Context on Pain Perception and Psychosocial Variables Associated with It in Elderly Persons: A Ranzomized Controlled Trial. Int J Environ Res Public Health. 2022 Sep 20;19(19):11855. doi: 10.3390/ijerph191911855.
PubMed 36231171Watson JA, Ryan CG, Cooper L, Ellington D, Whittle R, Lavender M, Dixon J, Atkinson G, Cooper K, Martin DJ. Pain Neuroscience Education for Adults With Chronic Musculoskeletal Pain: A Mixed-Methods Systematic Review and Meta-Analysis. J Pain. 2019 Oct;20(10):1140.e1-1140.e22. doi: 10.1016/j.jpain.2019.02.011. Epub 2019 Mar 1.
PubMed 30831273Afzal Z, Mansfield CJ, Bleacher J, Briggs M. RETURN TO ADVANCED STRENGTH TRAINING AND WEIGHTLIFTING IN AN ATHLETE POST-LUMBAR DISCECTOMY UTILIZING PAIN NEUROSCIENCE EDUCATION AND PROPER PROGRESSION: RESIDENT'S CASE REPORT. Int J Sports Phys Ther. 2019 Sep;14(5):804-817.
PubMed 31598418Maguire N, Chesterton P, Ryan C. The Effect of Pain Neuroscience Education on Sports Therapy and Rehabilitation Students' Knowledge, Attitudes, and Clinical Recommendations Toward Athletes With Chronic Pain. J Sport Rehabil. 2019 Jul 1;28(5):438-443. doi: 10.1123/jsr.2017-0212. Epub 2018 Oct 15.
PubMed 29405811Hooper SL, Mackinnon LT. Monitoring overtraining in athletes. Recommendations. Sports Med. 1995 Nov;20(5):321-7. doi: 10.2165/00007256-199520050-00003. No abstract available.
PubMed 8571005Scrimshaw SV, Maher C. Responsiveness of visual analogue and McGill pain scale measures. J Manipulative Physiol Ther. 2001 Oct;24(8):501-4. doi: 10.1067/mmt.2001.118208.
PubMed 11677548
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Pain Education Program in the Sport Population
- ClinicalTrials.gov ID
- NCT05645562
- Acronym / sponsor ID
- 280CER22
- Keywords
- Pain education, Athlete, Pain catastrophizing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 9 Dec 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.
This study is designed to evaluate the effects of a pain neuroscience education program in pain perception, wellness and pain catastrophizing of youth athletes. For this, an experimental study with an intervention group (IG) and a control group (CG) is designed. During 12 weeks of the 2022-2023 season, CG will receive a self-care education program, with information about health habits in the sport (rest, nutrition, body care and recovery). Meanwhile, IG will also receive a pain neuroscience education program, with information about biological, psychological and perceptual aspect of pain in the sports context. The study will be developed in the Sport High Performance Centre of Balearic Islands, from January to May. All athletes from this sports centre will be invited to participate in the study throughout an e-mail invitation from their sport regional federation. Prior to the beginning of the study, all participants will sign the inform consent. The Ethical Committee of the local university approved this study (280CER22). One week before intervention period, all athletes will be required to complete questionnaire about sociodemographic and sportive data (age, sex, and sport experience). Body mass and height will be also evaluated. Also, all the athletes will be required to complete three questionnaires about pain level, wellness and pain catastrophizing. Pain level and wellness will be evaluated prior to the start of the intervention and weekly, until finishing the intervention period. The pain catastrophizing level will be evaluated before and after the intervention period of the study. We hypothesized that those athletes who receive the pain neuroscience education program will increase wellness and decrease pain level and catastrophizing perception compared to those athletes who received a self-care educational program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Pain neuroscience education programIntervention group will receive a pain neuroscience education program (once time per month, during 4 months). This program will include information about biological, psychological and perceptual aspects of pain in the sport context. |
| Control group | Active comparator | Behavioral: Self-care education programThe control group will receive a self-care education program (once time per month, during 4 months). This program will include information about health habits in the sport. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- to have at least 14 years old
- to have at least 2 years of experience in the sport
Key exclusion criteria (2 listed)
- to have sustained an injury during the previous 6 months to start of the study
- to have sustained a surgery during the previous 12 months to start of the study
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 program1. Types of pain (peripherical and central pain) 2. Pain as information. 3. Benign and harmful pain 4. Psychological factors and pain in sport (Injuries, catastrophizing and pain) | Behavioural | Intervention group |
| Self-care education program1. The importance of resting 2. Nutritional habits 3. Recovery techniques for athletes 4. Principles of stretching, strengthening and endurance training | Behavioural | Control group |
Primary outcome
Wellness level
Time frame: Change from baseline and between group differences in wellness during and after the intervention period of 12 weeks
It is composed by seven questions about wellness, perceived effort, training volume. Wellness was assessed throughout four questions about the subjective perception of the quality of sleep, the amount of stress, the level of perceived fatigue, mood and perceived muscle damage. Each question is individually scored from 1 ("Very, very low, or very, very good") to 5 ("Very, very high, or very, very bad"), being 25 the maximal punctuation.
Pain level
Time frame: Change from baseline and between group differences in pain during and after the intervention period of 12 weeks
Pain intensity is assessed by using the Pain Visual Analog Scale (VAS, 0-10), ranging from 0 (no pain) to 10 (the worst imaginable pain). In case of pain existence, anatomical location, duration (days), sports practice affection (yes/no) were also collected
Pain catastrophizing level
Time frame: Change from baseline and between group differences in pain catastrophizing after the intervention period of 12 weeks
It is designed to evaluate the catastrophizing level of athletes throughout the Pain Catastrophism Scale (PCS). The PCS assesses catastrophic level associated to pain experience through thirteen 4-points Likert items (from 0, not at all, to 4, all the time). Apart from global Catastrophism, PCS evaluates four subscales regarding rumination, helplessness, and magnification. The maximal score is 50 points.
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 21 Oct 2024.
- Background: PubMed 29051168O'Sullivan K, O'Sullivan PB, Gabbett TJ. Pain and fatigue in sport: are they so different? Br J Sports Med. 2018 May;52(9):555-556. doi: 10.1136/bjsports-2017-098159. Epub 2017 Oct 19. No abstract available.
- Background: PubMed 36231171Vicente-Mampel J, Gargallo P, Bautista IJ, Blanco-Gimenez P, de Bernardo Tejedor N, Alonso-Martin M, Martinez-Soler M, Baraja-Vegas L. Impact of Pain Neuroscience Education Program in Community Physiotherapy Context on Pain Perception and Psychosocial Variables Associated with It in Elderly Persons: A Ranzomized Controlled Trial. Int J Environ Res Public Health. 2022 Sep 20;19(19):11855. doi: 10.3390/ijerph191911855.
- Background: PubMed 30831273Watson JA, Ryan CG, Cooper L, Ellington D, Whittle R, Lavender M, Dixon J, Atkinson G, Cooper K, Martin DJ. Pain Neuroscience Education for Adults With Chronic Musculoskeletal Pain: A Mixed-Methods Systematic Review and Meta-Analysis. J Pain. 2019 Oct;20(10):1140.e1-1140.e22. doi: 10.1016/j.jpain.2019.02.011. Epub 2019 Mar 1.
- Background: PubMed 31598418Afzal Z, Mansfield CJ, Bleacher J, Briggs M. RETURN TO ADVANCED STRENGTH TRAINING AND WEIGHTLIFTING IN AN ATHLETE POST-LUMBAR DISCECTOMY UTILIZING PAIN NEUROSCIENCE EDUCATION AND PROPER PROGRESSION: RESIDENT'S CASE REPORT. Int J Sports Phys Ther. 2019 Sep;14(5):804-817.
- Background: PubMed 29405811Maguire N, Chesterton P, Ryan C. The Effect of Pain Neuroscience Education on Sports Therapy and Rehabilitation Students' Knowledge, Attitudes, and Clinical Recommendations Toward Athletes With Chronic Pain. J Sport Rehabil. 2019 Jul 1;28(5):438-443. doi: 10.1123/jsr.2017-0212. Epub 2018 Oct 15.
- Background: PubMed 8571005Hooper SL, Mackinnon LT. Monitoring overtraining in athletes. Recommendations. Sports Med. 1995 Nov;20(5):321-7. doi: 10.2165/00007256-199520050-00003. No abstract available.
- Background: PubMed 11677548Scrimshaw SV, Maher C. Responsiveness of visual analogue and McGill pain scale measures. J Manipulative Physiol Ther. 2001 Oct;24(8):501-4. doi: 10.1067/mmt.2001.118208.
- Individual participant dataSharing planned: No
Related trials for Pain
Active, not recruiting
Pain and Opioids: Integrated Treatment In Veterans
Chronic Pain, Opioid-use Disorder
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
Recruiting
Cancer Pain Management Using a Web-based Intervention
Cancer of Breast, Depressive Symptoms
Recruiting
Meditation for Older Adults With Chronic Low Back Pain
Chronic Low Back Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 program and Self-care education program in people with Pain and Sports, run by University of the Balearic Islands 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 21 Oct 2024. 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?
Wellness level (time frame: Change from baseline and between group differences in wellness during and after the intervention period of 12 weeks). 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?
On the ClinicalTrials.gov record for NCT05645562, which also lists 7 linked publications.
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 21 Oct 2024; AzTrials last refreshed its copy on 31 Oct 2026.