PNE Effectiveness Cluster Trial

Sponsor

University of Utah (Other)

Overall Status

Completed

CT.gov ID

NCT03168165

Collaborator

(none)

316

Enrollment

Locations

Arms

24.2

Actual Duration (Months)

7.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neck Pain Low Back Pain Chronic Pain	Other: Pain neuroscience education training	N/A

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.

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 Design

Study Type:

Interventional

Actual Enrollment :

316 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Cluster randomized trialCluster 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

Actual Primary Completion Date :

Jun 1, 2019

Actual Study Completion Date :

Jun 1, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function [2 week and 12 week]
Change score of Physical Function scores from baseline

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BenchMark	Birmingham	Alabama	United States	35242-8601
2	BenchMark	Birmingham	Alabama	United States	35243-2366
3	BenchMark	Helena	Alabama	United States	35080-3773
4	BenchMark	Hoover	Alabama	United States	35244-1254
5	BenchMark	Moody	Alabama	United States	35004-3101
6	BenchMark	Phenix City	Alabama	United States	36867-7484
7	Benchmark Physical Therapy	Acworth	Georgia	United States	30101-8352
8	BenchMark	Alpharetta	Georgia	United States	30005-4202
9	BenchMark	Atlanta	Georgia	United States	30306-4530
10	BenchMark	Atlanta	Georgia	United States	30308-1245
11	BenchMark	Atlanta	Georgia	United States	30316-6833
12	BenchMark	Atlanta	Georgia	United States	30318-3117
13	BenchMark	Atlanta	Georgia	United States	30319
14	BenchMark	Atlanta	Georgia	United States	30342-1461
15	BenchMark	Austell	Georgia	United States	30106-8531
16	BenchMark	Canton	Georgia	United States	30114-5603
17	BenchMark	Canton	Georgia	United States	30115-9376
18	BenchMark	Carrollton	Georgia	United States	30117-4456
19	BenchMark	Cartersville	Georgia	United States	30121-3305
20	BenchMark	Columbus	Georgia	United States	31909-5649
21	BenchMark	Dallas	Georgia	United States	30157-4702
22	BenchMark	Decatur	Georgia	United States	30033-5305
23	BenchMark	Dunwoody	Georgia	United States	30338-4163
24	BenchMark	Hiram	Georgia	United States	30141-2692
25	BenchMark	Jasper	Georgia	United States	30143-8704
26	BenchMark	Kennesaw	Georgia	United States	30144-3210
27	Rehab South	Lawrenceville	Georgia	United States	30046-8767
28	BenchMark	Marietta	Georgia	United States	30060-9412
29	BenchMark	Marietta	Georgia	United States	30062-4197
30	BenchMark	Marietta	Georgia	United States	30064-5037
31	BenchMark	Marietta	Georgia	United States	30067-8642
32	BenchMark	Marietta	Georgia	United States	30068-5418
33	Rehab South	Newnan	Georgia	United States	30265-6506
34	Rehab South	Peachtree City	Georgia	United States	30269-1571
35	BenchMark	Peachtree City	Georgia	United States	30269
36	BenchMark	Roswell	Georgia	United States	30075-7524
37	BenchMark	Roswell	Georgia	United States	30076-0929
38	BenchMark	Roswell	Georgia	United States	30076-3866
39	BenchMark	Smyrna	Georgia	United States	30080-9213
40	BenchMark	Suwanee	Georgia	United States	30024-9104
41	BenchMark	Tucker	Georgia	United States	30084-4916

Sponsors and Collaborators

University of Utah

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elizabeth Lane, DPT, University of Utah

ClinicalTrials.gov Identifier:

NCT03168165

Other Study ID Numbers:

00097154

First Posted:

May 30, 2017

Last Update Posted:

Jul 29, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Low Back Pain

Chronic Pain

Neck Pain

Study Results

No Results Posted as of Jul 29, 2020