Procedural Framing and Epidural Steroid Injection Outcomes

Официальное название

PEACE Study: Psychophysical Enhancement to Augment Conservative and Epidural Steroid Injection Outcomes: A Multi-Center International Randomized Trial

Обзор

Back pain is the leading cause of disability and military medical boards across the globe. Epidural steroid injections (ESI) are the most commonly performed pain procedure in the world. There is strong evidence that the placebo effect for all pain treatments, including ESI, is greater than the intrinsic effect. The placebo effect is highly dependent on a patient's 'expectations', and therefore how the procedure is framed. This study aims to compare ESI when the procedure is framed very positively- as is often done in clinical practice vs. more neutrally (which is less commonly done in clinical practice but consistent with evidence). The placebo effect is also stronger for procedures than medications. The evidence on the benefits of ESI is highly dependent on whether it is compiled by interventional doctors who perform the procedure or non-interventional researchers. In order to determine how 'framing' a treatment affects pain outcomes, the investigative team will conduct a 3-arm randomized trial comparing positive framing of ESI, neutral framing of ESI, and medications, in patients with lumbosacral radiculopathy.

Подробное описание

Two hundred and ten eligible individuals will be randomized in blocks of 10 in a 2:2:1 ratio to receive positive framing for ESI (treatment group), neutral framing for ESI (control group), or pharmacological therapy and instructions to exercise (active control group), respectively. There will suballocation based on whether the patient has unilateral or bilateral pain (i.e., whether the participant would receive a transforaminal ESI or an interlaminar ESI, respectively). This is because there may be differences in outcomes (transforaminal injections for unilateral pain may be more effective than an interlaminar injection for bilateral pain), as well as possible differences in side effects.

For the 84 individuals randomized to the study group (positive framing of ESI), the investigators will provide 5 slides with bullet points and images outlining peer-reviewed studies, reviews and guidelines on ESI that present the treatment in a more positive light (consistent with the views of most people who perform ESIs), but still consistent with evidence. These slides will contain references to high-quality articles and there will be an investigator present to answer questions. There is a very wide range in how a procedure is presented to patients, and this framework is consistent with how ESI are presented to patients by pain practitioners from all over the world. This material is all publicly available but has been compiled in presentation form.

For the 84 individuals in the ESI control group, the investigative team will provide a 1-slide overview on ESI that is slightly less optimistic, consistent with how many non-pain-physicians view ESI including that the evidence for surgery reduction is questionable.

For the 42 individuals in the active control group who will receive a first-line medication for neuropathic and non-structured instructions to exercise, the investigators will provide a 1-side overview that presents the raw, neutral facts on adjuvants for sciatica (some guidelines recommend them, others do not, but some recommend a trial of conservative care for back pain before interventions; there are no medications across the globe approved for lumbosacral radiculopathy).

Вмешательства

• Поведенческое Behavioral manipulation of ESI expectations
  5-slide summary of ESI portrayed in a positive light, accompanied by a study investigator.
• Другое No behavioral manipulation of ESI expectations
  1-slide summary of ESI portrayed in a neutral light.
• Другое No behavioral manipulation of pharmacotherapy expectations
  1-slide summary of medications for neuropathic pain portrayed in a neutral light.

Первичные конечные точки

• Mean reduction in average leg pain [Срок оценки: 4 weeks]

Вторичные конечные точки (12)

• Leg pain at rest [Срок оценки: Up to 15 minutes after the procedure]
• Leg pain with activity [Срок оценки: Up to 15 minutes after the procedure]
• Back pain at rest [Срок оценки: Up to 15 minutes after the procedure]
• Back pain with activity [Срок оценки: Up to 15 minutes after the procedure]
• Patient satisfaction [Срок оценки: Up to 15 minutes after the procedure]
• Average leg pain [Срок оценки: 4 weeks]
• Average back pain [Срок оценки: 4 weeks]
• Worst leg pain [Срок оценки: 4 weeks]
• Worst back pain [Срок оценки: 4 weeks]
• Oswestry Disability Index (ODI) [Срок оценки: 4 weeks]
• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: 4 weeks]
• Athens Insomnia Scale [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• Age > 18
• Lumbosacral radicular pain based on history and physical exam (e.g. pain radiating into one or both lower extremities, sensory loss, muscle weakness, positive straight leg raising test etc.)
• Duration of pain >6 weeks
• NRS leg pain score > 4 (or if 3/10, greater or equal to back pain)
• MRI evidence of spinal pathology consistent with symptoms
• Candidates for ESI and pharmacotherapy

Критерии исключения

• Untreated coagulopathy
• Previous spine surgery
• No MRI or non-concordant MRI study
• Leg pain > 15 years duration
• Epidural steroid injection within past 2 years
• Signs or symptoms of cauda equina syndrome
• Previous failed trials with gabapentin and pregabalin and tricyclic antidepressants and duloxetine
• Allergic reactions to contrast dye prohibiting injection (e.g., tranforaminal ESI), gabapentinoids, tricyclic antidepressants or duloxetine, and contraindications to all of the above medications
• Referrals from surgery for diagnostic injections for surgical evaluation
• Serious medical (e.g. congestive heart failure) or psychiatric (untreated depression) condition that might preclude optimal outcome
• Pregnancy
• Inability to understand basic English

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Northwestern University — Chicago
• Walter Reed National Military Medical Center — Bethesda

Таиланд · 1 центр

• Phramongkutklao Military Hospital — Bangkok

Украина · 1 центр

• First Lviv Medical Union — Lviv

Публикации

• Schmidt S, Loef M, Ostermann T, Walach H. Treatment effects in pharmacological clinical randomized controlled trials are mainly due to placebo. J Clin Epidemiol. 2025 Mar;179:111658. doi: 10.1016/j.jclinepi.2024.111658. Epub 2024 Dec 27. PMID 39733973
• Kaptchuk TJ, Stason WB, Davis RB, Legedza AR, Schnyer RN, Kerr CE, Stone DA, Nam BH, Kirsch I, Goldman RH. Sham device v inert pill: randomised controlled trial of two placebo treatments. BMJ. 2006 Feb 18;332(7538):391-7. doi: 10.1136/bmj.38726.603310.55. Epub 2006 Feb 1. PMID 16452103
• Sebastian A, Wyld L, Morgan JL. Examining the variation in consent in general surgery. Ann R Coll Surg Engl. 2024 Feb;106(2):140-149. doi: 10.1308/rcsann.2023.0020. Epub 2023 May 23. PMID 37218649
• Kern A, Kramm C, Witt CM, Barth J. The influence of personality traits on the placebo/nocebo response: A systematic review. J Psychosom Res. 2020 Jan;128:109866. doi: 10.1016/j.jpsychores.2019.109866. Epub 2019 Nov 7. PMID 31760341
• Kang H, Miksche MS, Ellingsen DM. Association between personality traits and placebo effects: a preregistered systematic review and meta-analysis. Pain. 2023 Mar 1;164(3):494-508. doi: 10.1097/j.pain.0000000000002753. Epub 2022 Aug 10. PMID 35947877

Идентификаторы

NCT: NCT07498140 · STU00225684

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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