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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Self-care education program
  1. The importance of resting
  2. Nutritional habits
  3. Recovery techniques for athletes
  4. Principles of stretching, strengthening and endurance training
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.
Behavioral: Pain neuroscience education program
  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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of the Balearic Islands

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 3, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 12, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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