Back PainNCT02449876
The Feasibility of Using Neuroscience Education in Adults Over 65 Years Old With Chronic Low Back and/or Lower Extremity Pain
A study testing Neuroscience Education in people with Back Pain and Lower Extremity Pain, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Back Pain, Lower Extremity Pain
- What is being tested?
- Neuroscience Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 11 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute of Human Performance
Syracuse, New York, 13202
About this study
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
Read the 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.
- Conditions
- Back Pain, Lower Extremity Pain
- Being tested
- Neuroscience Education
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroscience EducationOther
Also called Therapeutic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Neuroscience Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tampa Scale of Kinesiophobia
Measured: 2 weeks
Pain Disability Index
Measured: 2 weeks
Neuroscience education acceptance and understanding survey
Adapted from Louw 2013, Am J Phys. Med. Rehabil
Measured: 2 weeks
Preferred and fast gait speed
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startDec 2015
- Primary completionSep 2016
- Study completion11 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Rufa, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449876
- Sponsor's protocol ID
- TNE 123
- Status last verified
- Apr 2017
- First submitted
- 18 May 2015
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Using Neuroscience Education in Adults Over 65 Years Old With Chronic Low Back and/or Lower Extremity Pain
- ClinicalTrials.gov ID
- NCT02449876
- Acronym / sponsor ID
- TNE 123
- Conditions
- Back Pain, Lower Extremity Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- 11 Apr 2017 (actual)
- First posted
- 20 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuroscience Education | Experimental | Other: Neuroscience EducationSubjects 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuroscience EducationAlso: Therapeutic Neuroscience EducationThe 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. | Other | Neuroscience Education |
Primary outcome
Tampa Scale of Kinesiophobia
Time frame: 2 weeks
Pain Disability Index
Time frame: 2 weeks
Neuroscience education acceptance and understanding survey
Time frame: 2 weeks
Adapted from Louw 2013, Am J Phys. Med. Rehabil
Preferred and fast gait speed
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroscience Education in people with Back Pain and Lower Extremity Pain, run by State University of New York - Upstate Medical University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tampa Scale of Kinesiophobia (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.