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Neck PainPNENCT03168165

PNE Effectiveness Cluster Trial

A study testing Pain neuroscience education training in people with Neck Pain and Low Back Pain, run by University of Utah at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Neck Pain, Low Back Pain, Chronic Pain
What is being tested?
Pain neuroscience education training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
316 participants
Where
41 sitesUnited States
Study dates
24 May 2017to 1 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.)

Who cannot join

  • 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

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites
  • Benchmark Physical Therapy

    Acworth, Georgia, 30101-8352

  • BenchMark

    Alpharetta, Georgia, 30005-4202

  • BenchMark

    Atlanta, Georgia, 30306-4530

  • BenchMark

    Atlanta, Georgia, 30308-1245

  • BenchMark

    Atlanta, Georgia, 30316-6833

  • BenchMark

    Atlanta, Georgia, 30318-3117

  • BenchMark

    Atlanta, Georgia, 30319

  • BenchMark

    Atlanta, Georgia, 30342-1461

  • BenchMark

    Austell, Georgia, 30106-8531

  • BenchMark

    Birmingham, Alabama, 35242-8601

  • BenchMark

    Birmingham, Alabama, 35243-2366

  • BenchMark

    Canton, Georgia, 30114-5603

  • BenchMark

    Canton, Georgia, 30115-9376

  • BenchMark

    Carrollton, Georgia, 30117-4456

  • BenchMark

    Cartersville, Georgia, 30121-3305

  • BenchMark

    Columbus, Georgia, 31909-5649

  • BenchMark

    Dallas, Georgia, 30157-4702

  • BenchMark

    Decatur, Georgia, 30033-5305

  • BenchMark

    Dunwoody, Georgia, 30338-4163

  • BenchMark

    Helena, Alabama, 35080-3773

  • BenchMark

    Hiram, Georgia, 30141-2692

  • BenchMark

    Hoover, Alabama, 35244-1254

  • BenchMark

    Jasper, Georgia, 30143-8704

  • BenchMark

    Kennesaw, Georgia, 30144-3210

  • Rehab South

    Lawrenceville, Georgia, 30046-8767

  • BenchMark

    Marietta, Georgia, 30060-9412

  • BenchMark

    Marietta, Georgia, 30062-4197

  • BenchMark

    Marietta, Georgia, 30064-5037

  • BenchMark

    Marietta, Georgia, 30067-8642

  • BenchMark

    Marietta, Georgia, 30068-5418

  • BenchMark

    Moody, Alabama, 35004-3101

  • Rehab South

    Newnan, Georgia, 30265-6506

  • Rehab South

    Peachtree City, Georgia, 30269-1571

  • BenchMark

    Peachtree City, Georgia, 30269

  • BenchMark

    Phenix City, Alabama, 36867-7484

  • BenchMark

    Roswell, Georgia, 30075-7524

  • BenchMark

    Roswell, Georgia, 30076-0929

  • BenchMark

    Roswell, Georgia, 30076-3866

  • BenchMark

    Smyrna, Georgia, 30080-9213

  • BenchMark

    Suwanee, Georgia, 30024-9104

  • BenchMark

    Tucker, Georgia, 30084-4916

Other trials in United States

About this study

Official title: The Effectiveness of Training Physical Therapists in Pain Neuroscience Education on Patient Reported Outcomes for Patients With Chronic Spinal Pain

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.

Read the 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.

Being tested
Pain neuroscience education training
Medical subject headings
Neck Pain, Low Back Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pain neuroscience education trainingOther

    PNE training will consist of 6 weeks online training followed by one day training session.

Study groups in NCT03168165
Study groupRoleWhat they receive
Usual CareNo interventionUsual care, no intervention
Pain Neuroscience Education TrainingExperimentalThe 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.
Receives: Other: Pain neuroscience education training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function

    Change score of Physical Function scores from baseline

    Measured: 2 week and 12 week

Secondary outcomes (4)
  1. Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference

    Change score of Pain Interference scores from baseline

    Measured: 2 week and 12 week

  2. pain self-efficacy

    Measured by Pain Self-Efficacy Questionnaire

    Measured: 2 week and 12 week

  3. Autonomous motivation

    Measured by Treatment Self-regulation Questionnaire

    Measured: 2 week and 12 week

  4. Therapeutic Alliance

    As measured by Working Alliance Theory of Change Inventory

    Measured: 2 week and 12 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2017
  2. Study start24 May 2017
  3. Primary completion1 Jun 2019
  4. Study completion1 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster randomized trial
Masking
None (open label)
Enrolment
316 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03168165
Sponsor's protocol ID
00097154
Acronym
PNE
Status last verified
Jul 2020
First submitted
23 May 2017
Last updated
29 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lane E, Barnes C, Fritz JM. Differences in Pain Experience Among Different Racial and Ethnic Groups. Phys Ther. 2024 Oct 2;104(10):pzae001. doi: 10.1093/ptj/pzae001.

    PubMed 38181396
  • 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.

    PubMed 34354017
  • 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.

    PubMed 30360762

Questions about this trial

What is this clinical trial studying?

A study testing Pain neuroscience education training in people with Neck Pain and Low Back Pain, run by University of Utah at 41 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (time frame: 2 week and 12 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03168165, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.

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PNE Effectiveness Cluster Trial (NCT03168165) | AzTrials