NCT05645562

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 3, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2023

Completed
Last Updated

October 21, 2024

Status Verified

March 1, 2023

Enrollment Period

Same day

First QC Date

December 1, 2022

Last Update Submit

October 17, 2024

Conditions

Keywords

Pain educationAthletePain catastrophizing

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

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.

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.

Behavioral: Self-care education program

Interventions

1. 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)

Intervention group

1. The importance of resting 2. Nutritional habits 3. Recovery techniques for athletes 4. Principles of stretching, strengthening and endurance training

Control group

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • to have at least 14 years old
  • to have at least 2 years of experience in the sport

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport High Performance Center of Balearic Islands

Palma de Mallorca, Balearic Islands, 07009, Spain

Location

Related Publications (7)

  • 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.

    PMID: 29051168BACKGROUND
  • 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.

    PMID: 36231171BACKGROUND
  • 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.

    PMID: 30831273BACKGROUND
  • 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.

    PMID: 31598418BACKGROUND
  • 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.

    PMID: 29405811BACKGROUND
  • 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.

    PMID: 8571005BACKGROUND
  • 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.

    PMID: 11677548BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2022

First Posted

December 9, 2022

Study Start

February 3, 2023

Primary Completion

February 3, 2023

Study Completion

May 12, 2023

Last Updated

October 21, 2024

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations