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Pain Neuroscience Education in Old Adults.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03523949
Recruitment Status : Not yet recruiting
First Posted : May 14, 2018
Last Update Posted : May 14, 2018
Information provided by (Responsible Party):
Marc Terradas Monllor, University of Barcelona

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Healthy Behavioral: PNE Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Study of the Effectiveness of Pain Neuroscience Education in the Elderly.
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : September 1, 2019

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.

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. 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).

  2. Pain Catastrophism. [ Time Frame: baseline, pre-PNE, immediately after PNE ]
    Participants will be asked to complete the Pain Catastrophizing Scale (PCS) (Spanish version).

  3. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03523949

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Contact: Marc Terradas, Msc 652 948 632 ext +34

Sponsors and Collaborators
University of Barcelona


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Responsible Party: Marc Terradas Monllor, Principal Investigator, University of Barcelona Identifier: NCT03523949     History of Changes
Other Study ID Numbers: END65
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marc Terradas Monllor, University of Barcelona:
Pain Neuroscience Education
Pain Education