Effects of Motor Imagery in Pain Modulation and Median Nerve Mechanosensitive in Healthy Patients

June 7, 2021 updated by: Josue Fernandez Carnero, Universidad Rey Juan Carlos
The aim of this study are 1) to determinate the effectiveness of motor imagery or strength training in differens aspects of pain modulation. 2) evaluate the functional improvement of the hand by a motor imagery protocol.

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.
100

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 Locations

  • Spain
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Universidad Rey Juan Carlos

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • be under 18
  • any pathology which provoke pain.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
Experimental: Action observation
The patients will observe a 25 minutes clip of neurodynamic exercises of the hand.
Other: Mirror therapy
With a mirror glasses on, do the neurodynamic exercises with the non-dominant hand while the patient is looking at the dominant hand
Other: Neurodynamic exercises
active movement of the dominant hand. Do neurodynamic exercises.
Other: Strength
Execute a short strength training for the dominant hand
Experimental: Mirror Therapy
With a mirror glasses, the patients will execute neurodynamic movements of their non-dominant hand during 25 minutes.
Other: Neurodynamic exercises
active movement of the dominant hand. Do neurodynamic exercises.
Other: Strength
Execute a short strength training for the dominant hand
Other: Action observation
look at a clip of a hand doing neurodynamic exercises.
Active Comparator: Strength Training
Strength protocol for the dominant hand.
Other: Mirror therapy
With a mirror glasses on, do the neurodynamic exercises with the non-dominant hand while the patient is looking at the dominant hand
Other: Neurodynamic exercises
active movement of the dominant hand. Do neurodynamic exercises.
Other: Action observation
look at a clip of a hand doing neurodynamic exercises.
Experimental: Neurodynamic exercise
Active neurodynamic exercises for the dominant hand.
Other: Mirror therapy
With a mirror glasses on, do the neurodynamic exercises with the non-dominant hand while the patient is looking at the dominant hand
Other: Strength
Execute a short strength training for the dominant hand
Other: Action observation
look at a clip of a hand doing neurodynamic exercises.

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
Conditioned pain modulation
Time Frame: Change from baseline at 2 weeks
Diffused noxious inhibitory control system will be measure with tourniquet test
Change from baseline at 2 weeks
Pressure pain threshold
Time Frame: Change from baseline at 2 weeks
Three consecutive trials of pressure pain threshold on the active trigger point at a rate of 1 kg/sec at intervals of 30 seconds were conducted.
Change from baseline at 2 weeks
Cold hyperalgesia
Time Frame: Change from baseline at 2 weeks
10 seconds of a cold pack and after that, rating the pain from 0 to 10
Change from baseline at 2 weeks
Neural mechanosensitive
Time Frame: Change from baseline at 2 weeks
Upper Limb Neurodynamic test 1 (ULNT1)
Change from baseline at 2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Strength_grip
Time Frame: Change from baseline at 2 weeks
grip strength without pain
Change from baseline at 2 weeks
Imagine movement capacity
Time Frame: Change from baseline at 2 weeks

testing the capacity of imagine that their own body is movement. Movement Imagery Questionnaire-Revised (MIQ-R questionaire).

top score 56 and bottom score 8. The higher values indicates a better outcome.
Change from baseline at 2 weeks
Psychological factors_Anxiety
Time Frame: Change from baseline at 2 weeks
State Trait Anxiety Inventory (STAI-T). Top score 60 and bottom score 0. The higher values indicate worst outcomes.
Change from baseline at 2 weeks
Psychological factors_Depression
Time Frame: Change from baseline at 2 weeks

Beck Depression Inventory (BDI-II). the scores goes from 0 to 63. The higher values indicate worst outcomes.

Beck Depression Inventory (BDI-II)

Beck Depression Inventory (BDI-II)
Change from baseline at 2 weeks
Psychological factors_Kinesiophobia
Time Frame: Change from baseline at 2 weeks
Tampa Scale for Kinesiophobia. Total scores goes from 11 to 44.The higher values indicate worst outcomes.
Change from baseline at 2 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.
Universidad Rey Juan Carlos

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.
September 8, 2019

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.
January 31, 2020

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.
February 25, 2020

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).
August 9, 2019

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.
September 9, 2019

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.
September 11, 2019

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.
June 8, 2021

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.
June 7, 2021

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.
June 1, 2021

More Information

Terms related to this study

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.
  • 2703201906919

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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