Evaluation of Pain Neuroscience Education for Patients Who Experience Chronic Pain With Concurrent Opioid Dependence

NCT06442306 | Completed DMC

• 1 other identifier: 53966
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  Pre-intervention (baseline), post-intervention (4-months past baseline), and 90-day post-intervention (7-months past baseline)

Study Arms (2)

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.

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.

Other: General Health Education

Interventions

Pain Neuroscience Education OTHER

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.

Also known as: Neuroscience Education, Biopsychosocial pain education, Pain neurophysiology education, Pain science education, Therapeutic neuroscience education

Pain Neuroscience Education group

General Health Education OTHER

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.

General Health Education group

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Wichita State University: lead
• University of Kentucky: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Related Publications (28)

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MeSH Terms

Conditions

Chronic Pain; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Anne Harrison, PhD

  University of Kentucky

  STUDY CHAIR

• Nicole D Windsor, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Tony English, PhD

  University of Kentucky

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist, PhD student, Teaching assistant

Model Details: Quasi-experimental study with a Pain Neuroscience Education group and a General Health Education group.

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: June 4, 2024
• Study Start: January 3, 2020
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data is available at any time.
• Access Criteria: Data can be accessed by emailing nicole.windsor@wichita.edu

Locations

US (1)