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

Primary Purpose

Back Pain, Lower Extremity Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neuroscience Education
Sponsored by
State University of New York - Upstate Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Human Performance

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neuroscience Education

Arm Description

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.

Outcomes

Primary Outcome Measures

Tampa Scale of Kinesiophobia
Pain Disability Index
Neuroscience education acceptance and understanding survey
Adapted from Louw 2013, Am J Phys. Med. Rehabil
Preferred and fast gait speed

Secondary Outcome Measures

Full Information

First Posted
May 18, 2015
Last Updated
April 11, 2017
Sponsor
State University of New York - Upstate Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02449876
Brief Title
The Feasibility of Using Neuroscience Education in Adults Over 65 Years Old With Chronic Low Back and/or Lower Extremity Pain
Official Title
The Feasibility of Using Neuroscience Education in Adults Over 65 Years Old With Chronic Low Back and/or Lower Extremity Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
April 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York - Upstate Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
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. Butler D, Moseley L, eds. Explain pain. Australia: NOI Group Publishing; 2003. 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. Maier-Riehle B, Harter M. The effects of back schools--a meta-analysis. Int J Rehabil Res. 2001;24(3):199-206. 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. Nachemson AL. Newest knowledge of low back pain. A critical look. Clin Orthop Relat Res. 1992;(279)(279):8-20. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Lower Extremity Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuroscience Education
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Neuroscience Education
Other Intervention Name(s)
Therapeutic Neuroscience Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tampa Scale of Kinesiophobia
Time Frame
2 weeks
Title
Pain Disability Index
Time Frame
2 weeks
Title
Neuroscience education acceptance and understanding survey
Description
Adapted from Louw 2013, Am J Phys. Med. Rehabil
Time Frame
2 weeks
Title
Preferred and fast gait speed
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Institute of Human Performance
City
Syracuse
State/Province
New York
ZIP/Postal Code
13202
Country
United States

12. IPD Sharing Statement

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

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