- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05645562
Pain Education Program in the Sport Population
October 17, 2024 updated by: University of the Balearic Islands
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Balearic Islands
-
Palma De Mallorca, Balearic Islands, Spain, 07009
- Sport High Performance Center of Balearic Islands
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- to have at least 14 years old
- to have at least 2 years of experience in the sport
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Active Comparator: Control group
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.
|
|
|
Experimental: Intervention group
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.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Change from baseline and between group differences in wellness during and after the intervention period of 12 weeks
|
|
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
|
Change from baseline and between group differences in pain during and after the intervention period of 12 weeks
|
|
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.
|
Change from baseline and between group differences in pain catastrophizing after the intervention period of 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Watson 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.
- 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.
- Vicente-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.
- Afzal 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.
- Maguire 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.
- Scrimshaw 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.
- Hooper 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 3, 2023
Primary Completion (Actual)
February 3, 2023
Study Completion (Actual)
May 12, 2023
Study Registration Dates
First Submitted
December 1, 2022
First Submitted That Met QC Criteria
December 1, 2022
First Posted (Actual)
December 9, 2022
Study Record Updates
Last Update Posted (Actual)
October 21, 2024
Last Update Submitted That Met QC Criteria
October 17, 2024
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 280CER22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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