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PNE Effectiveness Cluster Trial (PNE)

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ClinicalTrials.gov Identifier: NCT03168165
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Elizabeth Lane, University of Utah

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.

Condition or disease Intervention/treatment Phase
Neck Pain Low Back Pain Chronic Pain Other: Pain neuroscience education training Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 316 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomized trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness of Training Physical Therapists in Pain Neuroscience Education on Patient Reported Outcomes for Patients With Chronic Spinal Pain
Actual Study Start Date : May 24, 2017
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : May 1, 2019

Arm Intervention/treatment
No Intervention: Usual Care
Usual care, no intervention
Experimental: Pain Neuroscience Education Training
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
PNE training will consist of 6 weeks online training followed by one day training session.



Primary Outcome Measures :
  1. Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function [ Time Frame: 2 week and 12 week ]
    Change score of Physical Function scores from baseline


Secondary Outcome Measures :
  1. Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference [ Time Frame: 2 week and 12 week ]
    Change score of Pain Interference scores from baseline

  2. pain self-efficacy [ Time Frame: 2 week and 12 week ]
    Measured by Pain Self-Efficacy Questionnaire

  3. Autonomous motivation [ Time Frame: 2 week and 12 week ]
    Measured by Treatment Self-regulation Questionnaire

  4. Therapeutic Alliance [ Time Frame: 2 week and 12 week ]
    As measured by Working Alliance Theory of Change Inventory



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03168165


Contacts
Contact: elizabeth lane, DPT 2517143199 elizabeth.lane@utah.edu

Locations
United States, Alabama
BenchMark Recruiting
Birmingham, Alabama, United States, 35242-8601
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Birmingham, Alabama, United States, 35243-2366
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Helena, Alabama, United States, 35080-3773
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Hoover, Alabama, United States, 35244-1254
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Moody, Alabama, United States, 35004-3101
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Phenix City, Alabama, United States, 36867-7484
Contact: Elizabeth lane    251-714-3199    elane@bmrp.com   
United States, Georgia
Benchmark Physical Therapy Recruiting
Acworth, Georgia, United States, 30101-8352
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Alpharetta, Georgia, United States, 30005-4202
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Atlanta, Georgia, United States, 30306-4530
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Atlanta, Georgia, United States, 30308-1245
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Atlanta, Georgia, United States, 30316-6833
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Atlanta, Georgia, United States, 30318-3117
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Atlanta, Georgia, United States, 30319
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Atlanta, Georgia, United States, 30342-1461
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Austell, Georgia, United States, 30106-8531
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Canton, Georgia, United States, 30114-5603
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Canton, Georgia, United States, 30115-9376
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Carrollton, Georgia, United States, 30117-4456
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Cartersville, Georgia, United States, 30121-3305
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Columbus, Georgia, United States, 31909-5649
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Dallas, Georgia, United States, 30157-4702
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Decatur, Georgia, United States, 30033-5305
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Dunwoody, Georgia, United States, 30338-4163
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Hiram, Georgia, United States, 30141-2692
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Jasper, Georgia, United States, 30143-8704
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Kennesaw, Georgia, United States, 30144-3210
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
Rehab South Recruiting
Lawrenceville, Georgia, United States, 30046-8767
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Marietta, Georgia, United States, 30060-9412
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Marietta, Georgia, United States, 30062-4197
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Marietta, Georgia, United States, 30064-5037
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Marietta, Georgia, United States, 30067-8642
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Marietta, Georgia, United States, 30068-5418
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
Rehab South Recruiting
Newnan, Georgia, United States, 30265-6506
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
Rehab South Recruiting
Peachtree City, Georgia, United States, 30269-1571
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Peachtree City, Georgia, United States, 30269
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Roswell, Georgia, United States, 30075-7524
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Roswell, Georgia, United States, 30076-0929
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Roswell, Georgia, United States, 30076-3866
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Smyrna, Georgia, United States, 30080-9213
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Suwanee, Georgia, United States, 30024-9104
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
BenchMark Recruiting
Tucker, Georgia, United States, 30084-4916
Contact: Elizabeth Lane    251-714-3199    elane@bmrp.com   
Sponsors and Collaborators
University of Utah

Responsible Party: Elizabeth Lane, DPT, University of Utah
ClinicalTrials.gov Identifier: NCT03168165     History of Changes
Other Study ID Numbers: 00097154
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Chronic Pain
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms