PNE Effectiveness Cluster Trial
PNE
The Effectiveness of Training Physical Therapists in Pain Neuroscience Education on Patient Reported Outcomes for Patients With Chronic Spinal Pain
1 other identifier
interventional
316
1 country
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Typical duration for not_applicable
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2017
CompletedStudy Start
First participant enrolled
May 24, 2017
CompletedFirst Posted
Study publicly available on registry
May 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedJuly 29, 2020
July 1, 2020
2 years
May 23, 2017
July 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
Change score of Physical Function scores from baseline
2 week and 12 week
Secondary Outcomes (4)
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
2 week and 12 week
pain self-efficacy
2 week and 12 week
Autonomous motivation
2 week and 12 week
Therapeutic Alliance
2 week and 12 week
Study Arms (2)
Usual Care
NO INTERVENTIONUsual care, no intervention
Pain Neuroscience Education Training
EXPERIMENTALThe 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.
Interventions
PNE training will consist of 6 weeks online training followed by one day training session.
Eligibility Criteria
You may qualify if:
- 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.)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
BenchMark
Birmingham, Alabama, 35242-8601, United States
BenchMark
Birmingham, Alabama, 35243-2366, United States
BenchMark
Helena, Alabama, 35080-3773, United States
BenchMark
Hoover, Alabama, 35244-1254, United States
BenchMark
Moody, Alabama, 35004-3101, United States
BenchMark
Phenix City, Alabama, 36867-7484, United States
Benchmark Physical Therapy
Acworth, Georgia, 30101-8352, United States
BenchMark
Alpharetta, Georgia, 30005-4202, United States
BenchMark
Atlanta, Georgia, 30306-4530, United States
BenchMark
Atlanta, Georgia, 30308-1245, United States
BenchMark
Atlanta, Georgia, 30316-6833, United States
BenchMark
Atlanta, Georgia, 30318-3117, United States
BenchMark
Atlanta, Georgia, 30319, United States
BenchMark
Atlanta, Georgia, 30342-1461, United States
BenchMark
Austell, Georgia, 30106-8531, United States
BenchMark
Canton, Georgia, 30114-5603, United States
BenchMark
Canton, Georgia, 30115-9376, United States
BenchMark
Carrollton, Georgia, 30117-4456, United States
BenchMark
Cartersville, Georgia, 30121-3305, United States
BenchMark
Columbus, Georgia, 31909-5649, United States
BenchMark
Dallas, Georgia, 30157-4702, United States
BenchMark
Decatur, Georgia, 30033-5305, United States
BenchMark
Dunwoody, Georgia, 30338-4163, United States
BenchMark
Hiram, Georgia, 30141-2692, United States
BenchMark
Jasper, Georgia, 30143-8704, United States
BenchMark
Kennesaw, Georgia, 30144-3210, United States
Rehab South
Lawrenceville, Georgia, 30046-8767, United States
BenchMark
Marietta, Georgia, 30060-9412, United States
BenchMark
Marietta, Georgia, 30062-4197, United States
BenchMark
Marietta, Georgia, 30064-5037, United States
BenchMark
Marietta, Georgia, 30067-8642, United States
BenchMark
Marietta, Georgia, 30068-5418, United States
Rehab South
Newnan, Georgia, 30265-6506, United States
Rehab South
Peachtree City, Georgia, 30269-1571, United States
BenchMark
Peachtree City, Georgia, 30269, United States
BenchMark
Roswell, Georgia, 30075-7524, United States
BenchMark
Roswell, Georgia, 30076-0929, United States
BenchMark
Roswell, Georgia, 30076-3866, United States
BenchMark
Smyrna, Georgia, 30080-9213, United States
BenchMark
Suwanee, Georgia, 30024-9104, United States
BenchMark
Tucker, Georgia, 30084-4916, United States
Related Publications (2)
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.
PMID: 34354017DERIVEDLane 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.
PMID: 30360762DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DPT
Study Record Dates
First Submitted
May 23, 2017
First Posted
May 30, 2017
Study Start
May 24, 2017
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
July 29, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share