Clinical trial NCT06442306: Evaluation of Pain Neuroscience Education for Patients Who Experience Chronic Pain With Concurrent Opioid Dependence
Official title: Development of a Pain Neuroscience Education Program for Patients Who Are Opioid Dependence With Concurrent Chronic Musculoskeletal Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Wichita State University
Sponsor class: OTHER
Collaborators: name: University of Kentucky
First posted: 2024-06-04
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental study with a Pain Neuroscience Education group and a General Health Education group.
Primary purpose: TREATMENT

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 (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.

Eligibility criteria: Inclusion Criteria:

* Subjects who were actively participating in an Opioid Management Program.

Exclusion Criteria:

* 18 years of age or younger
* Score of 24 or less on the Mini Mental State Examination

Primary outcomes:
measure: Tampa Scale for Kinesiophobia (TSK-11)
timeFrame: Pre-intervention (baseline), post-intervention (4-months past baseline), and 90-day post-intervention (7-months past baseline)
measure: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: Pre-intervention (baseline), post-intervention (4-months past baseline), and 90-day post-intervention (7-months past baseline)
measure: Neurophysiology of Pain Questionnaire
timeFrame: Pre-intervention (baseline), post-intervention (4-months past baseline), and 90-day post-intervention (7-months past baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Anne Harrison, PhD
role: STUDY_CHAIR
affiliation: University of Kentucky
name: Nicole D Windsor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky
name: Tony English, PhD
role: STUDY_DIRECTOR
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