Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442306
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2024-05-09
Brief Title:
Evaluation of Pain Neuroscience Education for Patients Who Experience Chronic Pain With Concurrent Opioid Dependence
Sponsor:
Wichita State University
Organization:
Wichita State University
Study Overview
Official Title:
Development of a Pain Neuroscience Education Program for Patients Who Are Opioid Dependence With Concurrent Chronic Musculoskeletal Pain
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 With the opioid epidemic the healthcare system now has a population of patients who experience CMP with concurrent OpD CMPOpD 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 CMPOpD 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 CMPOpD
Detailed Description:
Methods Study Design This study was a pre-test-post-test quasi-experimental design with patients suffering from CMPOpD 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 consentHIPAA 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 patients 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 CMPOpD 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 CMPOpD 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 v270 SPSS Inc Chicago IL USA The significance level was set at P005 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 Mauchlys Test of Sphericity to correct for violations Bonferronis correction was used as needed Pearsons 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
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 consentHIPAA 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 patients 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 CMPOpD 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 CMPOpD 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 v270 SPSS Inc Chicago IL USA The significance level was set at P005 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 Mauchlys Test of Sphericity to correct for violations Bonferronis correction was used as needed Pearsons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None