NCT03523949

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.

Trial Health

45
At Risk

Trial Health Score

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

Timeline
17mo left

Started Nov 2018

Longer than P75 for not_applicable healthy

Status
withdrawn

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

Study Progress85%
Nov 2018Sep 2027

First Submitted

Initial submission to the registry

April 30, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 14, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
8.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Expected
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 30, 2018

Last Update Submit

April 28, 2026

Conditions

Healthy

Keywords

Pain Neuroscience EducationElderlyPain Education

Outcome Measures

Primary Outcomes (1)

  • Knowledge of Pain Neuroscience. Changes from baseline to immediately after PNE.

    Participants will be asked to complete the Neurophysiology of Pain Questionnaire (NPQ) (Spanish version)

    baseline, pre-PNE, immediately after PNE

Secondary Outcomes (3)

  • Pain Attitudes.

    baseline, pre-PNE, immediately after PNE

  • Pain Catastrophism.

    baseline, pre-PNE, immediately after PNE

  • Pain-related Fear of Movement.

    baseline, pre-PNE, immediately after PNE

Study Arms (1)

PNE.

EXPERIMENTAL

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

Interventions

PNEBEHAVIORAL

The PNE will be delivered by a physiotherapist in a single, group-based session.

PNE.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Louw A, Podalak J, Zimney K, Schmidt S, Puentedura EJ. Can pain beliefs change in middle school students? A study of the effectiveness of pain neuroscience education. Physiother Theory Pract. 2018 Jul;34(7):542-550. doi: 10.1080/09593985.2017.1423142. Epub 2018 Jan 8.

    PMID: 29308954BACKGROUND

  • Moseley L. Unraveling the barriers to reconceptualization of the problem in chronic pain: the actual and perceived ability of patients and health professionals to understand the neurophysiology. J Pain. 2003 May;4(4):184-9. doi: 10.1016/s1526-5900(03)00488-7.

    PMID: 14622702BACKGROUND

  • Cox T, Louw A, Puentedura EJ. An abbreviated therapeutic neuroscience education session improves pain knowledge in first-year physical therapy students but does not change attitudes or beliefs. J Man Manip Ther. 2017 Feb;25(1):11-21. doi: 10.1080/10669817.2015.1122308. Epub 2016 Feb 10.

    PMID: 28855788BACKGROUND

  • Louw A, Diener I, Landers MR, Puentedura EJ. Preoperative pain neuroscience education for lumbar radiculopathy: a multicenter randomized controlled trial with 1-year follow-up. Spine (Phila Pa 1976). 2014 Aug 15;39(18):1449-57. doi: 10.1097/BRS.0000000000000444.

    PMID: 24875964BACKGROUND

  • Louw A, Butler DS, Diener I, Puentedura EJ. Development of a preoperative neuroscience educational program for patients with lumbar radiculopathy. Am J Phys Med Rehabil. 2013 May;92(5):446-52. doi: 10.1097/PHM.0b013e3182876aa4.

    PMID: 23478459BACKGROUND

  • 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

  • Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.

    PMID: 27351541BACKGROUND

  • Lluch E, Duenas L, Falla D, Baert I, Meeus M, Sanchez-Frutos J, Nijs J. Preoperative Pain Neuroscience Education Combined With Knee Joint Mobilization for Knee Osteoarthritis: A Randomized Controlled Trial. Clin J Pain. 2018 Jan;34(1):44-52. doi: 10.1097/AJP.0000000000000511.

    PMID: 28514231BACKGROUND

  • Louw A PT, PhD, Zimney K PT, DPT, Reed J PT, DPT, Landers M PT, DPT, PhD, Puentedura EJ PT, DPT, PhD. Immediate preoperative outcomes of pain neuroscience education for patients undergoing total knee arthroplasty: A case series. Physiother Theory Pract. 2019 Jun;35(6):543-553. doi: 10.1080/09593985.2018.1455120. Epub 2018 Mar 28.

    PMID: 29589782BACKGROUND

  • Nijs J, Paul van Wilgen C, Van Oosterwijck J, van Ittersum M, Meeus M. How to explain central sensitization to patients with 'unexplained' chronic musculoskeletal pain: practice guidelines. Man Ther. 2011 Oct;16(5):413-8. doi: 10.1016/j.math.2011.04.005. Epub 2011 May 31.

    PMID: 21632273BACKGROUND

  • Andias R, Neto M, Silva AG. The effects of pain neuroscience education and exercise on pain, muscle endurance, catastrophizing and anxiety in adolescents with chronic idiopathic neck pain: a school-based pilot, randomized and controlled study. Physiother Theory Pract. 2018 Sep;34(9):682-691. doi: 10.1080/09593985.2018.1423590. Epub 2018 Jan 10.

    PMID: 29319386BACKGROUND

  • Rufa A PT, DPT, OCS, Beissner K PT, PhD, Dolphin M PT, DPT, MS, OCS. The use of pain neuroscience education in older adults with chronic back and/or lower extremity pain. Physiother Theory Pract. 2019 Jul;35(7):603-613. doi: 10.1080/09593985.2018.1456586. Epub 2018 Mar 30.

    PMID: 29601227BACKGROUND
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Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 30, 2018

First Posted

May 14, 2018

Study Start

November 1, 2018

Primary Completion

June 1, 2019

Study Completion (Estimated)

September 1, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04