PNE Effectiveness Cluster Trial
Condition: Neck Pain; Low Back Pain; Chronic Pain
MeSH terms: Low Back Pain; Chronic Pain; Neck Pain
Study type: Interventional

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.
    

Intervention name(s): Pain neuroscience education training
Intervention type(s): Other
Intervention description(s): PNE training will consist of 6 weeks online training followed by one day training session.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cluster randomized trial
Masking: None (Open Label)
Primary purpose: Treatment