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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35242-8601
- BenchMark
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Birmingham、Alabama、アメリカ、35243-2366
- BenchMark
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Helena、Alabama、アメリカ、35080-3773
- BenchMark
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Hoover、Alabama、アメリカ、35244-1254
- BenchMark
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Moody、Alabama、アメリカ、35004-3101
- BenchMark
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Phenix City、Alabama、アメリカ、36867-7484
- BenchMark
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Georgia
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Acworth、Georgia、アメリカ、30101-8352
- Benchmark Physical Therapy
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Alpharetta、Georgia、アメリカ、30005-4202
- BenchMark
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Atlanta、Georgia、アメリカ、30306-4530
- BenchMark
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Atlanta、Georgia、アメリカ、30308-1245
- BenchMark
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Atlanta、Georgia、アメリカ、30316-6833
- BenchMark
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Atlanta、Georgia、アメリカ、30318-3117
- BenchMark
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Atlanta、Georgia、アメリカ、30319
- BenchMark
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Atlanta、Georgia、アメリカ、30342-1461
- BenchMark
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Austell、Georgia、アメリカ、30106-8531
- BenchMark
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Canton、Georgia、アメリカ、30114-5603
- BenchMark
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Canton、Georgia、アメリカ、30115-9376
- BenchMark
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Carrollton、Georgia、アメリカ、30117-4456
- BenchMark
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Cartersville、Georgia、アメリカ、30121-3305
- BenchMark
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Columbus、Georgia、アメリカ、31909-5649
- BenchMark
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Dallas、Georgia、アメリカ、30157-4702
- BenchMark
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Decatur、Georgia、アメリカ、30033-5305
- BenchMark
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Dunwoody、Georgia、アメリカ、30338-4163
- BenchMark
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Hiram、Georgia、アメリカ、30141-2692
- BenchMark
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Jasper、Georgia、アメリカ、30143-8704
- BenchMark
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Kennesaw、Georgia、アメリカ、30144-3210
- BenchMark
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Lawrenceville、Georgia、アメリカ、30046-8767
- Rehab South
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Marietta、Georgia、アメリカ、30060-9412
- BenchMark
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Marietta、Georgia、アメリカ、30062-4197
- BenchMark
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Marietta、Georgia、アメリカ、30064-5037
- BenchMark
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Marietta、Georgia、アメリカ、30067-8642
- BenchMark
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Marietta、Georgia、アメリカ、30068-5418
- BenchMark
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Newnan、Georgia、アメリカ、30265-6506
- Rehab South
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Peachtree City、Georgia、アメリカ、30269-1571
- Rehab South
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Peachtree City、Georgia、アメリカ、30269
- BenchMark
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Roswell、Georgia、アメリカ、30075-7524
- BenchMark
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Roswell、Georgia、アメリカ、30076-0929
- BenchMark
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Roswell、Georgia、アメリカ、30076-3866
- BenchMark
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Smyrna、Georgia、アメリカ、30080-9213
- BenchMark
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Suwanee、Georgia、アメリカ、30024-9104
- BenchMark
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Tucker、Georgia、アメリカ、30084-4916
- BenchMark
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Usual Care
Usual care, no intervention
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実験的：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.
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PNE training will consist of 6 weeks online training followed by one day training session.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
時間枠：2 week and 12 week
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Change score of Physical Function scores from baseline
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2 week and 12 week
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
時間枠：2 week and 12 week
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Change score of Pain Interference scores from baseline
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2 week and 12 week
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pain self-efficacy
時間枠：2 week and 12 week
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Measured by Pain Self-Efficacy Questionnaire
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2 week and 12 week
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Autonomous motivation
時間枠：2 week and 12 week
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Measured by Treatment Self-regulation Questionnaire
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2 week and 12 week
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Therapeutic Alliance
時間枠：2 week and 12 week
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As measured by Working Alliance Theory of Change Inventory
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2 week and 12 week
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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