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PNE Effectiveness Cluster Trial (PNE)

Primary Purpose

Neck Pain, Low Back Pain, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pain neuroscience education training
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • Benchmark Physical Therapy
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • Rehab South
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • Rehab South
  • Rehab South
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark
  • BenchMark

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Pain Neuroscience Education Training

Arm Description

Usual care, no intervention

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.

Outcomes

Primary Outcome Measures

Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
Change score of Physical Function scores from baseline

Secondary Outcome Measures

Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
Change score of Pain Interference scores from baseline
pain self-efficacy
Measured by Pain Self-Efficacy Questionnaire
Autonomous motivation
Measured by Treatment Self-regulation Questionnaire
Therapeutic Alliance
As measured by Working Alliance Theory of Change Inventory

Full Information

First Posted
May 23, 2017
Last Updated
July 28, 2020
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT03168165
Brief Title
PNE Effectiveness Cluster Trial
Acronym
PNE
Official Title
The Effectiveness of Training Physical Therapists in Pain Neuroscience Education on Patient Reported Outcomes for Patients With Chronic Spinal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 24, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Low Back Pain, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
316 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care, no intervention
Arm Title
Pain Neuroscience Education Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pain neuroscience education training
Intervention Description
PNE training will consist of 6 weeks online training followed by one day training session.
Primary Outcome Measure Information:
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
Description
Change score of Physical Function scores from baseline
Time Frame
2 week and 12 week
Secondary Outcome Measure Information:
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
Description
Change score of Pain Interference scores from baseline
Time Frame
2 week and 12 week
Title
pain self-efficacy
Description
Measured by Pain Self-Efficacy Questionnaire
Time Frame
2 week and 12 week
Title
Autonomous motivation
Description
Measured by Treatment Self-regulation Questionnaire
Time Frame
2 week and 12 week
Title
Therapeutic Alliance
Description
As measured by Working Alliance Theory of Change Inventory
Time Frame
2 week and 12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
BenchMark
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242-8601
Country
United States
Facility Name
BenchMark
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243-2366
Country
United States
Facility Name
BenchMark
City
Helena
State/Province
Alabama
ZIP/Postal Code
35080-3773
Country
United States
Facility Name
BenchMark
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35244-1254
Country
United States
Facility Name
BenchMark
City
Moody
State/Province
Alabama
ZIP/Postal Code
35004-3101
Country
United States
Facility Name
BenchMark
City
Phenix City
State/Province
Alabama
ZIP/Postal Code
36867-7484
Country
United States
Facility Name
Benchmark Physical Therapy
City
Acworth
State/Province
Georgia
ZIP/Postal Code
30101-8352
Country
United States
Facility Name
BenchMark
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005-4202
Country
United States
Facility Name
BenchMark
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306-4530
Country
United States
Facility Name
BenchMark
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308-1245
Country
United States
Facility Name
BenchMark
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30316-6833
Country
United States
Facility Name
BenchMark
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318-3117
Country
United States
Facility Name
BenchMark
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30319
Country
United States
Facility Name
BenchMark
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-1461
Country
United States
Facility Name
BenchMark
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106-8531
Country
United States
Facility Name
BenchMark
City
Canton
State/Province
Georgia
ZIP/Postal Code
30114-5603
Country
United States
Facility Name
BenchMark
City
Canton
State/Province
Georgia
ZIP/Postal Code
30115-9376
Country
United States
Facility Name
BenchMark
City
Carrollton
State/Province
Georgia
ZIP/Postal Code
30117-4456
Country
United States
Facility Name
BenchMark
City
Cartersville
State/Province
Georgia
ZIP/Postal Code
30121-3305
Country
United States
Facility Name
BenchMark
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909-5649
Country
United States
Facility Name
BenchMark
City
Dallas
State/Province
Georgia
ZIP/Postal Code
30157-4702
Country
United States
Facility Name
BenchMark
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033-5305
Country
United States
Facility Name
BenchMark
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338-4163
Country
United States
Facility Name
BenchMark
City
Hiram
State/Province
Georgia
ZIP/Postal Code
30141-2692
Country
United States
Facility Name
BenchMark
City
Jasper
State/Province
Georgia
ZIP/Postal Code
30143-8704
Country
United States
Facility Name
BenchMark
City
Kennesaw
State/Province
Georgia
ZIP/Postal Code
30144-3210
Country
United States
Facility Name
Rehab South
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046-8767
Country
United States
Facility Name
BenchMark
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060-9412
Country
United States
Facility Name
BenchMark
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30062-4197
Country
United States
Facility Name
BenchMark
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30064-5037
Country
United States
Facility Name
BenchMark
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30067-8642
Country
United States
Facility Name
BenchMark
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30068-5418
Country
United States
Facility Name
Rehab South
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265-6506
Country
United States
Facility Name
Rehab South
City
Peachtree City
State/Province
Georgia
ZIP/Postal Code
30269-1571
Country
United States
Facility Name
BenchMark
City
Peachtree City
State/Province
Georgia
ZIP/Postal Code
30269
Country
United States
Facility Name
BenchMark
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30075-7524
Country
United States
Facility Name
BenchMark
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076-0929
Country
United States
Facility Name
BenchMark
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076-3866
Country
United States
Facility Name
BenchMark
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080-9213
Country
United States
Facility Name
BenchMark
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024-9104
Country
United States
Facility Name
BenchMark
City
Tucker
State/Province
Georgia
ZIP/Postal Code
30084-4916
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34354017
Citation
Lane E, Magel JS, Thackeray A, Greene T, Fino NF, Puentedura EJ, Louw A, Maddox D, Fritz JM. Effectiveness of training physical therapists in pain neuroscience education for patients with chronic spine pain: a cluster-randomized trial. Pain. 2022 May 1;163(5):852-860. doi: 10.1097/j.pain.0000000000002436.
Results Reference
derived
PubMed Identifier
30360762
Citation
Lane E, Fritz JM, Greene T, Maddox D. The effectiveness of training physical therapists in pain neuroscience education on patient reported outcomes for patients with chronic spinal pain: a study protocol for a cluster randomized controlled trial. BMC Musculoskelet Disord. 2018 Oct 25;19(1):386. doi: 10.1186/s12891-018-2269-2.
Results Reference
derived

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PNE Effectiveness Cluster Trial

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