Pain Neuroscience Education in Old Adults.

May 10, 2018 updated by: Marc Terradas Monllor, University of Barcelona

A Study of the Effectiveness of Pain Neuroscience Education in the Elderly.

The primary objectives of this study are to:

  • Evaluate the ability of the older adults to understand the biological processes underneath a pain experience.
  • Evaluate their ability to modify their behaviors and beliefs about pain and health.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to test the effectivity of a single, group-based session of pain neuroscience education (PNE) on old adults. Participants will be 65 years or older, and they will be recruited from primary care medical clinics, public lectures, community centers and through the word of mouth. The intervention consist in one educational session of pain neuroscience education delivered by a physiotherapist. The study design is a single arm, crossover clinical trial, participants will be assessed in 3 different times (1 month before PNE ,pre-PNE, post-PNE) for knowledge of pain neuroscience, pain attitudes, pain catastrophizing and pain-related fear of movement.

Study Type

Interventional

Enrollment (Anticipated)

60

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 Contact

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects 65 years old or more.
  • Able to speak and read in Spanish.

Exclusion Criteria:

  • Cognitive impairment. Global Deterioration Scale and Functional Assessment Staging (GDS-FAST) will be used for the screening, excluding the subjects with a level 3 or above in the GDS-FAST scale.

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PNE.
Procedure: This educational intervention is based in the latest evidence of pain neuroscience education, used in multiple rehabilitation programs. Its aim is to change the subject's pain understanding, teaching them the biological processes underneath the pain construct, as a mechanism to reduce itself and its related maladaptive thoughts and behaviors.
Behavioral: PNE
The PNE will be delivered by a physiotherapist in a single, group-based session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge of Pain Neuroscience. Changes from baseline to immediately after PNE.
Time Frame: baseline, pre-PNE, immediately after PNE
Participants will be asked to complete the Neurophysiology of Pain Questionnaire (NPQ) (Spanish version)
baseline, pre-PNE, immediately after PNE

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Attitudes.
Time Frame: baseline, pre-PNE, immediately after PNE
Participants will be asked to complete the Survey of Pain Attitudes Brief Version (SOPA-B) (Spanish version).
baseline, pre-PNE, immediately after PNE
Pain Catastrophism.
Time Frame: baseline, pre-PNE, immediately after PNE
Participants will be asked to complete the Pain Catastrophizing Scale (PCS) (Spanish version).
baseline, pre-PNE, immediately after PNE
Pain-related Fear of Movement.
Time Frame: baseline, pre-PNE, immediately after PNE
Participants will be asked to complete the Tampa Scale of Kinesiophobia (TSK-11) (Spanish version).
baseline, pre-PNE, immediately after PNE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Barcelona

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 (Anticipated)

June 1, 2018

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

April 30, 2018

First Submitted That Met QC Criteria

May 10, 2018

First Posted (Actual)

May 14, 2018

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 10, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • END65

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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