Chronic PainNCT06442306
Evaluation of Pain Neuroscience Education for Patients Who Experience Chronic Pain With Concurrent Opioid Dependence
A study testing Pain Neuroscience Education and General Health Education in people with Chronic Pain and Opioid Dependence, run by Wichita State University at 1 site in United States.
Trial summary
Chronic musculoskeletal pain (CMP) is estimated to affect over 100 million adults and is targeted as an instigator of opioid dependence (OpD). Opioid medications are often the first response for patients suffering with CMP; yet over 10 million people admit to misusing opioids annually. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Chronic Pain, Opioid Dependence
- What is being tested?
- Pain Neuroscience Education and General Health Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2020to 15 Jan 2021
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who were actively participating in an Opioid Management Program.
Who cannot join
- 18 years of age or younger
- Score of 24 or less on the Mini Mental State Examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Pain Neuroscience Education Program for Patients Who Are Opioid Dependence With Concurrent Chronic Musculoskeletal Pain
Chronic musculoskeletal pain (CMP) is estimated to affect over 100 million adults and is targeted as an instigator of opioid dependence (OpD). Opioid medications are often the first response for patients suffering with CMP; yet over 10 million people admit to misusing opioids annually. With the opioid epidemic, the healthcare system now has a population of patients who experience CMP with concurrent OpD (CMP/OpD). This persistent problem can create a perfect storm of kinesiophobia, reduced self-efficacy, and physical dysfunction. A critical component to chronic pain management is understanding how patients view their pain experience. Education may be one key that unlocks the door to functional improvement, but traditional physical therapy (PT) education utilizes anatomical models that focus on tissue damage and peripheral sources of pain. Researchers have explored educating people about pain via Pain Neuroscience Education (PNE), a cognitive-based intervention that facilitates understanding of the biological processes underpinning the pain state. PNE may facilitate understanding pain experiences that are normal and expected, with the intent to reduce fear and increase pain self-efficacy. As yet, utilization of PNE has not been researched in patients with CMP/OpD. Therefore, authors hypothesize that the introduction of an adapted PNE (a-PNE) curriculum, as a single intervention, may facilitate positive changes in kinesiophobia, pain self-efficacy, and knowledge of the neurophysiology of pain for patients with CMP/OpD.
Read the detailed description
Methods Study Design This study was a pre-test-post-test, quasi-experimental design with patients suffering from CMP/OpD being treated at a family practice clinic associated with University of Kentucky. A quasi-experimental study was chosen due to the small sample of convenience.
Patients Patients were recruited from an opioid management program (OMP) at the referenced family practice clinic. At the time of study recruitment, the OMP had 31 patients participating monthly.
Procedures The 21 participating patients were divided into two groups via a coin toss; 13 were included in the experimental group (PNE) and eight were included in the general health education control group (GHE).
All patients reviewed and signed the IRB approved consent/HIPAA form and performed the MMSE. Each patient completed the Tampa Scale of Kinesiophobia (TSK-11), Pain Self-Efficacy Questionnaire (PSEQ), and the Neurophysiology of Pain Questionnaire (NPQ) at the onset of the study. All intervention sessions were completed once per month directly after the patient's regularly scheduled monthly OMP appointment.
The PNE group received the a-PNE curriculum which was created with patient-friendly verbiage and used to educate subjects about the inner workings of the nervous system. The a-PNE curriculum, a PowerPoint presentation was divided into four, 15-minute, one-on-one sessions with the PI in a private treatment room to facilitate discussion and minimize distractions. The educational information was related directly to the patients' CMP/OpD experience to personalize the intervention and presented at a pace that was appropriate for each patient. At the conclusion of each session, the PNE group was provided handouts containing information that was reviewed during that session. At the end of the a-PNE intervention, the patients completed the three questionnaires.
The GHE group was provided practical education for healthy living over four monthly sessions, 15-minutes per session. The GHE intervention was comprised of topics promoting healthy living in a one-on-one session with the PI in a private treatment room to facilitate discussion. At the conclusion of each session, the GHE group was provided handouts containing information that was reviewed during the session. At the end of the GHE intervention, the patients completed the three questionnaires.
It should be noted that no patients were receiving other physical therapy interventions throughout the time of the study. The principal investigator removed exercise-related language and overt physical therapy-related topics to focus primarily on the psychosocial constructs for both groups. Considering the many factors surrounding this cohort, multiple sessions were chosen for the two groups to minimize the effects of CMP/OpD of decreased attention span, decreased working memory and decreased cognitive flexibility, which has been demonstrated in the literature.
Ninety days after the completion of the intervention sessions and the post-program assessments, a follow-up data collection was performed in which all patients completed the three questionnaires. After the research study was complete and all data collected, the GHE subjects were offered the identical a-PNE intervention which was utilized with the PNE group.
Statistical Analysis Statistical analyses were performed using the SPSS software (v.27.0, SPSS, Inc., Chicago, IL, USA). The significance level was set at P<0.05. The scores of three patients who did not complete the study were removed from the data set.
Normative distribution was evaluated utilizing the Shapiro-Wilk test. Descriptive statistics, including means and standard deviations (SD), were gathered for baseline demographic data. A group (a-PNE or GHE) by time (pre-intervention, post-intervention, and 90-day post-intervention) interaction analysis of variance (ANOVA) was completed for each dependent variable. Analysis included the Mauchly's Test of Sphericity to correct for violations. Bonferroni's correction was used as needed. Pearson's correlation was performed to inquire of correlation between variables.
Paired samples t-tests were conducted on each group and utilized to analyze pre-intervention to post-intervention and pre-intervention to 90-day post-intervention scores for each of the three dependent variables.
- Conditions
- Chronic Pain, Opioid Dependence
- Being tested
- Pain Neuroscience Education, General Health Education
- Keywords
- Chronic Musculoskeletal Pain, Opioid Dependence, Pain Neuroscience Education, Neurophysiology of Pain Questionnaire, Pain Self-Efficacy Questionnaire, Tampa Scale for Kinesiophobia
- Medical subject headings
- Chronic Pain, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience EducationOther
Also called Neuroscience Education, Biopsychosocial pain education, Pain neurophysiology education, Pain science education
Pain Neuroscience Education (PNE) is a cognitive-based education intervention that aims to change pain beliefs in patients experiencing CMP. Researchers have found PNE beneficial in assisting patients to reframe their understanding, attitudes, thoughts, and beliefs regarding their pain experience. PNE directs patients to relate chronic pain to overly sensitive nerves rather than assumed tissue damage. Further, PNE encourages patients to perform daily activities, work, and function in society, all despite pain. This facilitates behavior changes that are key in amending a patient's biopsychosocial state. Multiple sources make a strong case for the incorporation of PNE in having positive effects on reducing physical disability and modulating fear and anxiety in patients with CMP. Researchers have established a positive influence of PNE toward decreased kinesiophobia and have demonstrated a relation between increased self-efficacy and increased functional ability.
General Health EducationOther
General Health Education included: 20 Benefits of Walking 30 Minutes a Day; Why You Should Quit: Smoking Cessation; Heat vs. Cold: How to Use it For Pain Control; Sleep Hygiene.
| Study group | Role | What they receive |
|---|---|---|
| Pain Neuroscience Education group | Experimental | The PNE group received the a-PNE education curriculum which was created with patient-friendly verbiage and used to educate subjects about the inner workings of the nervous system. The a-PNE curriculum, a PowerPoint presentation was divided into four, 15-minute, one-on-one sessions with the PI in a private treatment room to facilitate discussion and minimize distractions. The educational information was related directly to the patients' CMP/OpD experience to personalize the intervention and presented at a pace that was appropriate for each patient. At the conclusion of each session, the PNE group was provided handouts containing information that was reviewed during that session. At the end of the a-PNE intervention, the patients completed the three questionnaires. Receives: Other: Pain Neuroscience Education |
| General Health Education group | Active comparator | The GHE group was provided practical education for healthy living over four monthly sessions, 15-minutes per session. The GHE intervention was comprised of topics promoting healthy living in a one-on-one session with the PI in a private treatment room to facilitate discussion. At the conclusion of each session, the GHE group was provided handouts containing information that was reviewed during the session. At the end of the GHE intervention, the patients completed the three questionnaires. Receives: Other: General Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tampa Scale for Kinesiophobia (TSK-11)
Kinesiophobia was measured by the 11-question TSK-11. Kinesiophobia is the fear of movement, or the fear of pain associated with movement. Subjects rate each item on a 4-point Likert scale with scoring ranging from "strongly disagree" to "strongly agree". The TSK-11 tool specifically assesses a subject's fear of pain due to movement and is a valid and reliable tool for measuring kinesiophobia. The highest score available on the TSK-11 is 44 points, with higher scores indicating increased fear. The minimum detectible change (MDC) for the TSK-11 is 5.6, minimal clinically important difference (MCID) is 6 points, and test-retest reliability is 0.81 (95% CI, 0.58-0.93).
Measured: Pre-intervention (baseline), post-intervention (4-months past baseline), and 90-day post-intervention (7-months past baseline)
Pain Self-Efficacy Questionnaire (PSEQ)
The patient's confidence with function despite pain, or self-efficacy, was measured by the Pain Self-Efficacy Questionnaire (PSEQ). The PSEQ measures a patient's confidence in performing certain tasks, despite pain, and has a maximum score of 60 points which relates to the most positive outcome for the subject (with zero being the lowest self-efficacy). The PSEQ is a valid and reliable tool for measuring pain self-efficacy with a test-retest reliability of 0.85 (95% CI, 0.74-0.92), MDC of 10.9 and MCID of 11 points.
Measured: Pre-intervention (baseline), post-intervention (4-months past baseline), and 90-day post-intervention (7-months past baseline)
Neurophysiology of Pain Questionnaire
Knowledge gained and retained regarding the neurophysiology supporting the CMP experience was measured via the Neurophysiology of Pain Questionnaire (NPQ). The NPQ is a 12-item assessment that seeks to measure how a subject understands the biological mechanisms that sustain the pain experience. Statements are answered true, false, or unsure. There are 12 points possible with a higher score indicating more retained pain knowledge. Post-intervention, the NPQ will ascertain the subject's understanding of the a-PNE curriculum. The NPQ currently has no test-retest reliability, MDC or MCID available.
Measured: Pre-intervention (baseline), post-intervention (4-months past baseline), and 90-day post-intervention (7-months past baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start3 Jan 2020
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental study with a Pain Neuroscience Education group and a General Health Education group.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wichita State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky
- Responsible party
- Principal investigator, Nicole D Windsor, University of Kentucky
- Investigators
- Anne Harrison, PhD, Study chair, University of KentuckyNicole D Windsor, PhD, Principal investigator, University of KentuckyTony English, PhD, Study director, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442306
- Sponsor's protocol ID
- 53966
- Status last verified
- Jun 2024
- First submitted
- 9 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Inquiries can be made to principal investigator. Study protocol, Subject de-identified demographics, outcome measure scores, statistical analysis.
Publications
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.
PubMed 27351541Dahlhamer J, Lucas J, Zelaya C, Nahin R, Mackey S, DeBar L, Kerns R, Von Korff M, Porter L, Helmick C. Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults - United States, 2016. MMWR Morb Mortal Wkly Rep. 2018 Sep 14;67(36):1001-1006. doi: 10.15585/mmwr.mm6736a2.
PubMed 30212442Louw 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 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.
PubMed 22133255Louw A, Puentedura EL, Mintken P. Use of an abbreviated neuroscience education approach in the treatment of chronic low back pain: a case report. Physiother Theory Pract. 2012 Jan;28(1):50-62. doi: 10.3109/09593985.2011.562602. Epub 2011 Jul 3.
PubMed 21721995Louw A, Zimney K, O'Hotto C, Hilton S. The clinical application of teaching people about pain. Physiother Theory Pract. 2016 Jul;32(5):385-95. doi: 10.1080/09593985.2016.1194652. Epub 2016 Jun 28.
PubMed 27351903Moseley GL, Nicholas MK, Hodges PW. A randomized controlled trial of intensive neurophysiology education in chronic low back pain. Clin J Pain. 2004 Sep-Oct;20(5):324-30. doi: 10.1097/00002508-200409000-00007.
PubMed 15322439Bodes Pardo G, Lluch Girbes E, Roussel NA, Gallego Izquierdo T, Jimenez Penick V, Pecos Martin D. Pain Neurophysiology Education and Therapeutic Exercise for Patients With Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):338-347. doi: 10.1016/j.apmr.2017.10.016. Epub 2017 Nov 11.
PubMed 29138049Moseley L. Combined physiotherapy and education is efficacious for chronic low back pain. Aust J Physiother. 2002;48(4):297-302. doi: 10.1016/s0004-9514(14)60169-0.
PubMed 12443524Lluch 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.
PubMed 28514231Beltran-Alacreu H, Lopez-de-Uralde-Villanueva I, Fernandez-Carnero J, La Touche R. Manual Therapy, Therapeutic Patient Education, and Therapeutic Exercise, an Effective Multimodal Treatment of Nonspecific Chronic Neck Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2015 Oct;94(10 Suppl 1):887-97. doi: 10.1097/PHM.0000000000000293.
PubMed 25888653Watson JA, Ryan CG, Cooper L, Ellington D, Whittle R, Lavender M, Dixon J, Atkinson G, Cooper K, Martin DJ. Pain Neuroscience Education for Adults With Chronic Musculoskeletal Pain: A Mixed-Methods Systematic Review and Meta-Analysis. J Pain. 2019 Oct;20(10):1140.e1-1140.e22. doi: 10.1016/j.jpain.2019.02.011. Epub 2019 Mar 1.
PubMed 30831273Wood L, Hendrick PA. A systematic review and meta-analysis of pain neuroscience education for chronic low back pain: Short-and long-term outcomes of pain and disability. Eur J Pain. 2019 Feb;23(2):234-249. doi: 10.1002/ejp.1314. Epub 2018 Oct 14.
PubMed 30178503Souza CM, Martins J, Libardoni TC, de Oliveira AS. Self-efficacy in patients with chronic musculoskeletal conditions discharged from physical therapy service: A cross-sectional study. Musculoskeletal Care. 2020 Sep;18(3):365-371. doi: 10.1002/msc.1469. Epub 2020 Apr 8.
PubMed 32267617Tsuji H, Tetsunaga T, Tetsunaga T, Nishida K, Misawa H, Ozaki T. The factors driving self-efficacy in intractable chronic pain patients: a retrospective study. J Orthop Surg Res. 2019 Dec 30;14(1):473. doi: 10.1186/s13018-019-1535-9.
PubMed 31888662Archer KR, Phelps KD, Seebach CL, Song Y, Riley LH 3rd, Wegener ST. Comparative study of short forms of the Tampa Scale for Kinesiophobia: fear of movement in a surgical spine population. Arch Phys Med Rehabil. 2012 Aug;93(8):1460-2. doi: 10.1016/j.apmr.2012.03.024. Epub 2012 Apr 3.
PubMed 22481127
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Pain Neuroscience Education Program for Patients Who Are Opioid Dependence With Concurrent Chronic Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT06442306
- Acronym / sponsor ID
- 53966
- Conditions
- Chronic Pain, Opioid Dependence
- Keywords
- Chronic Musculoskeletal Pain, Opioid Dependence, Pain Neuroscience Education, Neurophysiology of Pain Questionnaire, Pain Self-Efficacy Questionnaire, Tampa Scale for Kinesiophobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Wichita State UniversityUniversity, hospital or other
- Collaborators
- University of Kentucky
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 4 Jun 2024 (actual)
- 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.
Chronic musculoskeletal pain (CMP) is estimated to affect over 100 million adults and is targeted as an instigator of opioid dependence (OpD). Opioid medications are often the first response for patients suffering with CMP; yet over 10 million people admit to misusing opioids annually. With the opioid epidemic, the healthcare system now has a population of patients who experience CMP with concurrent OpD (CMP/OpD). This persistent problem can create a perfect storm of kinesiophobia, reduced self-efficacy, and physical dysfunction. A critical component to chronic pain management is understanding how patients view their pain experience. Education may be one key that unlocks the door to functional improvement, but traditional physical therapy (PT) education utilizes anatomical models that focus on tissue damage and peripheral sources of pain. Researchers have explored educating people about pain via Pain Neuroscience Education (PNE), a cognitive-based intervention that facilitates understanding of the biological processes underpinning the pain state. PNE may facilitate understanding pain experiences that are normal and expected, with the intent to reduce fear and increase pain self-efficacy. As yet, utilization of PNE has not been researched in patients with CMP/OpD. Therefore, authors hypothesize that the introduction of an adapted PNE (a-PNE) curriculum, as a single intervention, may facilitate positive changes in kinesiophobia, pain self-efficacy, and knowledge of the neurophysiology of pain for patients with CMP/OpD.
Detailed description
Methods Study Design This study was a pre-test-post-test, quasi-experimental design with patients suffering from CMP/OpD being treated at a family practice clinic associated with University of Kentucky. A quasi-experimental study was chosen due to the small sample of convenience.
Patients Patients were recruited from an opioid management program (OMP) at the referenced family practice clinic. At the time of study recruitment, the OMP had 31 patients participating monthly.
Procedures The 21 participating patients were divided into two groups via a coin toss; 13 were included in the experimental group (PNE) and eight were included in the general health education control group (GHE).
All patients reviewed and signed the IRB approved consent/HIPAA form and performed the MMSE. Each patient completed the Tampa Scale of Kinesiophobia (TSK-11), Pain Self-Efficacy Questionnaire (PSEQ), and the Neurophysiology of Pain Questionnaire (NPQ) at the onset of the study. All intervention sessions were completed once per month directly after the patient's regularly scheduled monthly OMP appointment.
The PNE group received the a-PNE curriculum which was created with patient-friendly verbiage and used to educate subjects about the inner workings of the nervous system. The a-PNE curriculum, a PowerPoint presentation was divided into four, 15-minute, one-on-one sessions with the PI in a private treatment room to facilitate discussion and minimize distractions. The educational information was related directly to the patients' CMP/OpD experience to personalize the intervention and presented at a pace that was appropriate for each patient. At the conclusion of each session, the PNE group was provided handouts containing information that was reviewed during that session. At the end of the a-PNE intervention, the patients completed the three questionnaires.
The GHE group was provided practical education for healthy living over four monthly sessions, 15-minutes per session. The GHE intervention was comprised of topics promoting healthy living in a one-on-one session with the PI in a private treatment room to facilitate discussion. At the conclusion of each session, the GHE group was provided handouts containing information that was reviewed during the session. At the end of the GHE intervention, the patients completed the three questionnaires.
It should be noted that no patients were receiving other physical therapy interventions throughout the time of the study. The principal investigator removed exercise-related language and overt physical therapy-related topics to focus primarily on the psychosocial constructs for both groups. Considering the many factors surrounding this cohort, multiple sessions were chosen for the two groups to minimize the effects of CMP/OpD of decreased attention span, decreased working memory and decreased cognitive flexibility, which has been demonstrated in the literature.
Ninety days after the completion of the intervention sessions and the post-program assessments, a follow-up data collection was performed in which all patients completed the three questionnaires. After the research study was complete and all data collected, the GHE subjects were offered the identical a-PNE intervention which was utilized with the PNE group.
Statistical Analysis Statistical analyses were performed using the SPSS software (v.27.0, SPSS, Inc., Chicago, IL, USA). The significance level was set at P<0.05. The scores of three patients who did not complete the study were removed from the data set.
Normative distribution was evaluated utilizing the Shapiro-Wilk test. Descriptive statistics, including means and standard deviations (SD), were gathered for baseline demographic data. A group (a-PNE or GHE) by time (pre-intervention, post-intervention, and 90-day post-intervention) interaction analysis of variance (ANOVA) was completed for each dependent variable. Analysis included the Mauchly's Test of Sphericity to correct for violations. Bonferroni's correction was used as needed. Pearson's correlation was performed to inquire of correlation between variables.
Paired samples t-tests were conducted on each group and utilized to analyze pre-intervention to post-intervention and pre-intervention to 90-day post-intervention scores for each of the three dependent variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experimental study with a Pain Neuroscience Education group and a General Health Education group.
| Arm | Type | Receives |
|---|---|---|
| Pain Neuroscience Education group | Experimental | Other: Pain Neuroscience EducationThe PNE group received the a-PNE education curriculum which was created with patient-friendly verbiage and used to educate subjects about the inner workings of the nervous system. The a-PNE curriculum, a PowerPoint presentation was divided into four, 15-minute, one-on-one sessions with the PI in a private treatment room to facilitate discussion and minimize distractions. The educational information was related directly to the patients' CMP/OpD experience to personalize the intervention and presented at a pace that was appropriate for each patient. At the conclusion of each session, the PNE group was provided handouts containing information that was reviewed during that session. At the end of the a-PNE intervention, the patients completed the three questionnaires. |
| General Health Education group | Active comparator | Other: General Health EducationThe GHE group was provided practical education for healthy living over four monthly sessions, 15-minutes per session. The GHE intervention was comprised of topics promoting healthy living in a one-on-one session with the PI in a private treatment room to facilitate discussion. At the conclusion of each session, the GHE group was provided handouts containing information that was reviewed during the session. At the end of the GHE intervention, the patients completed the three questionnaires. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who were actively participating in an Opioid Management Program.
Key exclusion criteria (2 listed)
- 18 years of age or younger
- Score of 24 or less on the Mini Mental State Examination
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 |
|---|---|---|
| Pain Neuroscience EducationAlso: Neuroscience Education, Biopsychosocial pain education, Pain neurophysiology education, Pain science educationPain Neuroscience Education (PNE) is a cognitive-based education intervention that aims to change pain beliefs in patients experiencing CMP. Researchers have found PNE beneficial in assisting patients to reframe their understanding, attitudes, thoughts, and beliefs regarding their pain experience. PNE directs patients to relate chronic pain to overly sensitive nerves rather than assumed tissue damage. Further, PNE encourages patients to perform daily activities, work, and function in society, all despite pain. This facilitates behavior changes that are key in amending a patient's biopsychosocial state. Multiple sources make a strong case for the incorporation of PNE in having positive effects on reducing physical disability and modulating fear and anxiety in patients with CMP. Researchers have established a positive influence of PNE toward decreased kinesiophobia and have demonstrated a relation between increased self-efficacy and increased functional ability. | Other | Pain Neuroscience Education group |
| General Health EducationGeneral Health Education included: 20 Benefits of Walking 30 Minutes a Day; Why You Should Quit: Smoking Cessation; Heat vs. Cold: How to Use it For Pain Control; Sleep Hygiene. | Other | General Health Education group |
Primary outcome
Tampa Scale for Kinesiophobia (TSK-11)
Time frame: Pre-intervention (baseline), post-intervention (4-months past baseline), and 90-day post-intervention (7-months past baseline)
Kinesiophobia was measured by the 11-question TSK-11. Kinesiophobia is the fear of movement, or the fear of pain associated with movement. Subjects rate each item on a 4-point Likert scale with scoring ranging from "strongly disagree" to "strongly agree". The TSK-11 tool specifically assesses a subject's fear of pain due to movement and is a valid and reliable tool for measuring kinesiophobia. The highest score available on the TSK-11 is 44 points, with higher scores indicating increased fear. The minimum detectible change (MDC) for the TSK-11 is 5.6, minimal clinically important difference (MCID) is 6 points, and test-retest reliability is 0.81 (95% CI, 0.58-0.93).
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: Pre-intervention (baseline), post-intervention (4-months past baseline), and 90-day post-intervention (7-months past baseline)
The patient's confidence with function despite pain, or self-efficacy, was measured by the Pain Self-Efficacy Questionnaire (PSEQ). The PSEQ measures a patient's confidence in performing certain tasks, despite pain, and has a maximum score of 60 points which relates to the most positive outcome for the subject (with zero being the lowest self-efficacy). The PSEQ is a valid and reliable tool for measuring pain self-efficacy with a test-retest reliability of 0.85 (95% CI, 0.74-0.92), MDC of 10.9 and MCID of 11 points.
Neurophysiology of Pain Questionnaire
Time frame: Pre-intervention (baseline), post-intervention (4-months past baseline), and 90-day post-intervention (7-months past baseline)
Knowledge gained and retained regarding the neurophysiology supporting the CMP experience was measured via the Neurophysiology of Pain Questionnaire (NPQ). The NPQ is a 12-item assessment that seeks to measure how a subject understands the biological mechanisms that sustain the pain experience. Statements are answered true, false, or unsure. There are 12 points possible with a higher score indicating more retained pain knowledge. Post-intervention, the NPQ will ascertain the subject's understanding of the a-PNE curriculum. The NPQ currently has no test-retest reliability, MDC or MCID available.
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 4 Jun 2024.
- Background: PubMed 27351541Louw 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.
- Background: PubMed 30212442Dahlhamer J, Lucas J, Zelaya C, Nahin R, Mackey S, DeBar L, Kerns R, Von Korff M, Porter L, Helmick C. Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults - United States, 2016. MMWR Morb Mortal Wkly Rep. 2018 Sep 14;67(36):1001-1006. doi: 10.15585/mmwr.mm6736a2.
- Background: PubMed 22133255Louw 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 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.
- Background: PubMed 21721995Louw A, Puentedura EL, Mintken P. Use of an abbreviated neuroscience education approach in the treatment of chronic low back pain: a case report. Physiother Theory Pract. 2012 Jan;28(1):50-62. doi: 10.3109/09593985.2011.562602. Epub 2011 Jul 3.
- Background: PubMed 27351903Louw A, Zimney K, O'Hotto C, Hilton S. The clinical application of teaching people about pain. Physiother Theory Pract. 2016 Jul;32(5):385-95. doi: 10.1080/09593985.2016.1194652. Epub 2016 Jun 28.
- Background: PubMed 15322439Moseley GL, Nicholas MK, Hodges PW. A randomized controlled trial of intensive neurophysiology education in chronic low back pain. Clin J Pain. 2004 Sep-Oct;20(5):324-30. doi: 10.1097/00002508-200409000-00007.
- Background: PubMed 29138049Bodes Pardo G, Lluch Girbes E, Roussel NA, Gallego Izquierdo T, Jimenez Penick V, Pecos Martin D. Pain Neurophysiology Education and Therapeutic Exercise for Patients With Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):338-347. doi: 10.1016/j.apmr.2017.10.016. Epub 2017 Nov 11.
- Background: PubMed 12443524Moseley L. Combined physiotherapy and education is efficacious for chronic low back pain. Aust J Physiother. 2002;48(4):297-302. doi: 10.1016/s0004-9514(14)60169-0.
- Background: PubMed 28514231Lluch 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.
- Background: PubMed 25888653Beltran-Alacreu H, Lopez-de-Uralde-Villanueva I, Fernandez-Carnero J, La Touche R. Manual Therapy, Therapeutic Patient Education, and Therapeutic Exercise, an Effective Multimodal Treatment of Nonspecific Chronic Neck Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2015 Oct;94(10 Suppl 1):887-97. doi: 10.1097/PHM.0000000000000293.
- Background: PubMed 30831273Watson JA, Ryan CG, Cooper L, Ellington D, Whittle R, Lavender M, Dixon J, Atkinson G, Cooper K, Martin DJ. Pain Neuroscience Education for Adults With Chronic Musculoskeletal Pain: A Mixed-Methods Systematic Review and Meta-Analysis. J Pain. 2019 Oct;20(10):1140.e1-1140.e22. doi: 10.1016/j.jpain.2019.02.011. Epub 2019 Mar 1.
- Background: PubMed 30178503Wood L, Hendrick PA. A systematic review and meta-analysis of pain neuroscience education for chronic low back pain: Short-and long-term outcomes of pain and disability. Eur J Pain. 2019 Feb;23(2):234-249. doi: 10.1002/ejp.1314. Epub 2018 Oct 14.
- Individual participant dataSharing planned: Yes. Inquiries can be made to principal investigator. Study protocol, Subject de-identified demographics, outcome measure scores, statistical analysis.
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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.
Anne Harrison, PhD study chair
University of Kentucky
Nicole D Windsor, PhD principal investigator
University of Kentucky
Tony English, PhD study director
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education and General Health Education in people with Chronic Pain and Opioid Dependence, run by Wichita State 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 2 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 4 Jun 2024. 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 for Kinesiophobia (TSK-11) (time frame: Pre-intervention (baseline), post-intervention (4-months past baseline), and 90-day post-intervention (7-months past baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06442306, which also lists 28 linked publications.
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 4 Jun 2024.