PNE Effectiveness Cluster Trial

Study Overview
=================
Brief Summary
-----------------
This is a cluster randomized trial that involves training regions of physical therapy clinics to use pain neuroscience education or continue with usual care. The investigators will examine outcomes for patients with chronic neck or back pain.

Detailed Description
-----------------
Chronic spinal pain is a very common and costly condition. An estimated 26.4% of Americans have experienced an episode low back pain (LBP) and 13.8% have experienced neck pain in the past 3 months. Lifetime prevalence of spinal pain ranges from 54% to 80% and the estimated healthcare costs for those with spinal pain are 57% higher than those without. While many with acute LBP have a favorable prognosis, those who develop chronic pain continue will experience persistent poor health and place a large burden on the healthcare system. With growing healthcare costs and mounting disability, there is increased demand for physical therapists to promote more effective self-management strategies for patients with chronic spinal pain. Education is a critical component of self-management. Pain neuroscience education (PNE) is an education method used by physical therapists to help patients understand the biology, physiology and psychological factors influencing their pain experience and to reconcile faulty cognitions and beliefs associated with persistent pain and disability8. PNE has been shown to have positive effects on patient-reported outcomes for a variety of spinal pain conditions. This study will examine the impact of widespread implementation of PNE into routine physical therapy care. The proposed mechanism of PNE is proposed to relate changes in patients' conceptualization of the pain experience, specifically concepts associated with fear, knowledge, and beliefs of pain. Additional research has identified autonomous motivation and self-efficacy as relevant to patients' behavioral responses to pain. Autonomous motivation is proposed to be an essential factor for behavior change, adhering to a treatment program and persistent positive health behavior changes. Autonomous motivation has not been examined as an influencing factor in the PNE model. Self-efficacy relates to the degree an individual feels they have control over their situation; and high self-efficacy has been associated with more active coping efforts. This study will examine self-efficacy and autonomous motivation as potential mediators of the ability of a PNE intervention improve functional outcomes in a pragmatic clinical environment. This project's overall goal is to determine the effectiveness of providing physical therapists with PNE training on patient-centered outcomes (physical function and pain interference) for patients with chronic neck or back pain receiving physical therapy. Secondarily, the investigators will explore mechanisms of effects of PNE by examining the role of autonomous motivation and self-efficacy. To accomplish these goals, the investigators will conduct a cluster-randomized clinical trial, randomly assigning groups of clinics to receive PNE training or usual care with no additional training for physical therapists working in the clinic. This design allows for maximum external validity and generalizability across outpatient physical therapy clinics. Primary Aims I. Compare effectiveness of PNE training vs. no additional training for physical therapists on patient-centered outcomes (physical function and pain interference) for patients with chronic spinal pain. The investigators hypothesize patients receiving treatment from physical therapists receiving PNE education will show greater improvement in patient-centered outcomes. Secondary Aims I. Compare the effects of PNE training vs. no additional training for physical therapists on the patient-physical therapist alliance. The investigators hypothesize patients receiving treatment from physical therapists receiving PNE education will show greater alliance with their physical therapist. II. Explore the mediating effects of autonomous motivation and self-efficacy on patient-centered outcomes. The investigators hypothesize autonomous motivation and/or self-efficacy will mediate the effects of education on patient-centered outcomes.

Official Title
-----------------
The Effectiveness of Training Physical Therapists in Pain Neuroscience Education on Patient Reported Outcomes for Patients With Chronic Spinal Pain

Conditions
-----------------
Neck Pain, Low Back Pain, Chronic Pain

Intervention / Treatment
-----------------
* Other: Pain neuroscience education training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-75 at time of first physical therapy session Primary reason for physical therapy is low back and/or neck pain Meets the NIH definition of chronic pain (i.e., neck or back pain on at least half the days in the past 6 months.) Exclusion Criteria: No spinal surgery within the previous 12 months No evidence of red flag conditions (e.g., cauda equine syndrome, cancer, fracture, infection or systemic disease) that requires immediate referral from physical therapy to medical care Not currently known to be pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Usual care, no intervention | |
| Experimental: Pain Neuroscience Education Training<br>The region of clinics randomized to this arm will receive PNE education, which consists of 6 weeks online training followed by an on-site training day. | Other: Pain neuroscience education training<br>* PNE training will consist of 6 weeks online training followed by one day training session.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function | Change score of Physical Function scores from baseline | 2 week and 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference | Change score of Pain Interference scores from baseline | 2 week and 12 week | 
| pain self-efficacy | Measured by Pain Self-Efficacy Questionnaire | 2 week and 12 week | 
| Autonomous motivation | Measured by Treatment Self-regulation Questionnaire | 2 week and 12 week | 
| Therapeutic Alliance | As measured by Working Alliance Theory of Change Inventory | 2 week and 12 week |