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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05645562
Other study ID # 280CER22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 3, 2023
Est. completion date May 12, 2023

Study information

Verified date March 2023
Source University of the Balearic Islands
Contact Natalia Romero franco, PhD
Phone 652632864
Email natalia.romero@uib.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date May 12, 2023
Est. primary completion date February 3, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Pain neuroscience education program
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 program
The importance of resting Nutritional habits Recovery techniques for athletes Principles of stretching, strengthening and endurance training

Locations

Country Name City State
Spain Sport High Performance Center of Balearic Islands Palma De Mallorca Balearic Islands

Sponsors (1)

Lead Sponsor Collaborator
University of the Balearic Islands

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from baseline and between group differences in wellness during and after the intervention period of 12 weeks
Primary 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 Change from baseline and between group differences in pain during and after the intervention period of 12 weeks
Primary 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. Change from baseline and between group differences in pain catastrophizing after the intervention period of 12 weeks
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