The Feasibility of Using Neuroscience Education in Adults Over 65 Years Old With Chronic Low Back and/or Lower Extremity Pain

NCT ID: NCT02449876

Last Updated: 2017-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-04-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Background: Health care professionals commonly provide education to patients who are in pain. Traditionally, this education has focused on pathoantaomical aspects of the patient's condition.(1,2) Despite the popularity of this type of education the evidence has indicated that it either has little effect (2-4) or in some cases can have a negative effect on pain and disability.(3,5-7) In contrast, therapeutic neuroscience education (TNE) directly addresses cognitions about pain by teaching patients basic pain physiology and addressing abnormal pain beliefs (e.g., pain=harm). TNE has been shown to produce positive changes in pain beliefs, including a reduction in pain catastrophizing, and improvements in both pain levels and pain-related disability. (2,3,8) To date, research on the impact of TNE has focused on working-aged adults. Pain however, is highly prevalent among the older adult population, leading to activity limitation and pain-related disability.(4-7) The purpose of this project is to determine whether older adults are receptive toTNE, if TNE can have an impact on the gait speed of older adults and if TNE can have an impact on pain beliefs.

Methods: This will be a single group, uncontoled pilot study of 15-20 adults aged 65 years and older who report low back or lower extremity pain. Subjects will be recurited from physician offices and the community via flyers and word of mouth. Subjects will be screened for eligibility and informed consent will be obtained. Inclusion criterion will include age over 65, self-reported back and/or lower extermity pain present on most days for at least three months, be independent with ambulation (with or without and assistive device) and English speaking. Exclusion criteria include cancer-related pain, recent (within 6 months) surgery 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 other diagnoses that impact mobility or rusult in cognitive limitations.

Upon enrollment in the study each subject will complete intake questionnaires (basic demographic information, the Tampa Scale of Kinesiophobia (TSK), Pain Disability Index (PDI), and Resilience Scale( RS), and one physical performance measure (Gait Speed, preferred and maximal).

The educational material will be delivered in two, one on one, meetings for a total time of approximately ninety minutes. The first meeting will last about one hour and all of the educational content will be delivered in this session. A supplemental handout (reference), which will highlight the concepts covered in the presentation, will be given to each subject. The second educational session will serve as a review of the material covered in the first meeting and described in the supplemental materials. During this session subjects will be encourage to ask questions and get clarification about any of the covered topics which are unclear. At the conclusion of the second session the surveys initially administered will be repeated (TKS, PDI, RS), the gait speed test will be repeated and a brief survey about the education will be administered.

1. Butler D, Moseley L, eds. Explain pain. Australia: NOI Group Publishing; 2003.
2. Brox JI, Storheim K, Grotle M, Tveito TH, Indahl A, Eriksen HR. Systematic review of back schools, brief education, and fear-avoidance training for chronic low back pain. Spine J. 2008;8(6):948-958.
3. Maier-Riehle B, Harter M. The effects of back schools--a meta-analysis. Int J Rehabil Res. 2001;24(3):199-206.
4. Koes BW, van Tulder MW, van der Windt WM, Bouter LM. The efficacy of back schools: A review of randomized clinical trials. J Clin Epidemiol. 1994;47(8):851-862.
5. Nachemson AL. Newest knowledge of low back pain. A critical look. Clin Orthop Relat Res. 1992;(279)(279):8-20.
6. Poiraudeau S, Rannou F, Baron G, et al. Fear-avoidance beliefs about back pain in patients with subacute low back pain. Pain. 2006;124(3):305-311.
7. Hirsch MS, Liebert RM. The physical and psychological experience of pain: The effects of labeling and cold pressor temperature on three pain measures in college women. Pain. 1998;77(1):41-48.
8. Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011;92(12):2041-2056.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Back Pain Lower Extremity Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Neuroscience Education

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.

Group Type EXPERIMENTAL

Neuroscience Education

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neuroscience Education

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Therapeutic Neuroscience Education

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

State University of New York - Upstate Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Adam Rufa

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institute of Human Performance

Syracuse, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TNE 123

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pain Neuroscience Education and Memory
NCT07252596 NOT_YET_RECRUITING NA