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.
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
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.
- Conditions
- Neck Pain, Low Back Pain, Chronic Pain
- 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 group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual care, no intervention |
| Pain Neuroscience Education Training | Experimental | 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. Receives: Other: Pain neuroscience education training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
Change score of Pain Interference scores from baseline
Measured: 2 week and 12 week
pain self-efficacy
Measured by Pain Self-Efficacy Questionnaire
Measured: 2 week and 12 week
Autonomous motivation
Measured by Treatment Self-regulation Questionnaire
Measured: 2 week and 12 week
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.
- First posted30 May 2017
- Study start24 May 2017
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Lane, University of Utah
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 38181396Lane 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 34354017Lane 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Training Physical Therapists in Pain Neuroscience Education on Patient Reported Outcomes for Patients With Chronic Spinal Pain
- ClinicalTrials.gov ID
- NCT03168165
- Acronym / sponsor ID
- PNE / 00097154
- Conditions
- Neck Pain, Low Back Pain, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 24 May 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual care, no intervention |
| Pain Neuroscience Education Training | Experimental | Other: Pain neuroscience education trainingThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain neuroscience education trainingPNE training will consist of 6 weeks online training followed by one day training session. | Other | Pain Neuroscience Education Training |
Primary outcome
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
Time frame: 2 week and 12 week
Change score of Physical Function scores from baseline
4 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
Time frame: 2 week and 12 week
pain self-efficacy
Time frame: 2 week and 12 week
Autonomous motivation
Time frame: 2 week and 12 week
Therapeutic Alliance
Time frame: 2 week and 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Derived from this study: PubMed 38181396Lane 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.
- Derived from this study: PubMed 34354017Lane 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.
- Derived from this study: PubMed 30360762Lane 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
41 sites in 1 country: see every site and its status.
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.