NCT02449876

Brief Summary

This is a pilot study to determine if neuroscience education is acceptable to adults over 65 and if it can have an impact on pain, pain beliefs and gait speed

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2017

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

9 months

First QC Date

May 18, 2015

Last Update Submit

April 11, 2017

Conditions

Outcome Measures

Primary Outcomes (4)

  • Tampa Scale of Kinesiophobia

    2 weeks

  • Pain Disability Index

    2 weeks

  • Neuroscience education acceptance and understanding survey

    Adapted from Louw 2013, Am J Phys. Med. Rehabil

    2 weeks

  • Preferred and fast gait speed

    2 weeks

Study Arms (1)

Neuroscience Education

EXPERIMENTAL

Subjects will have 2 sessions of education 2 weeks apart. After the first session subjects will be given a 50 page book "Why Do I Hurt" by Adriaan Louw. Session 1 will last approximately 60 minutes and session approximately 30 minutes.

Other: Neuroscience Education

Interventions

The following topics will be discussed in the education * Basic structure of the nervous system * Basic physiology of the nervous system * The function and importance of pain * Strategies to lessen the impact of pain The instruction will be delivered in an interactive manner so that questions are addressed immediately. At the conclusion of the session each subject will receive the book: Why Do I Hurt by Adriaan Louw to reinforce the information discussed in the session. Subjects will be asked to read the 50 page book prior to the second session. Session 2: The session will begin with a review of the topics discussed in Session 1 and contained in the book. Subject will be encouraged to ask questions and get clarification on any of the topics that are unclear.

Also known as: Therapeutic Neuroscience Education
Neuroscience Education

Eligibility Criteria

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

You may qualify if:

  • over 65 years old, have low back and/or lower extremity pain present on most days for at least three months, be independent with ambulation (with or without assistive device) and English speaking.

You may not qualify if:

  • cancer related pain, recent surgery (within 6 months) on the back or lower extremities affecting mobility, current ongoing treatment by another healthcare professional for low back or lower extremity pain (including physical therapy, chiropractic or massage) or the presence of other diagnoses that impact mobility or result in cognitive limitations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Human Performance

Syracuse, New York, 13202, United States

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

May 18, 2015

First Posted

May 20, 2015

Study Start

December 1, 2015

Primary Completion

September 1, 2016

Study Completion

April 11, 2017

Last Updated

April 12, 2017

Record last verified: 2017-04

Locations