Ethical examination of sham surgeries for relief of chronic pain in clinical practice

Abstract

Treatment of chronic pain is challenging for both patients and physicians alike. Interventional management of pain is often indicated for patients who are not helped by pharmacotherapy, and can include procedures such as neurectomy and vertebroplasty. However, randomized controlled trials of these procedures often demonstrate a significant improvement in symptomology among patients in the control arm who have instead undergone a sham surgery, which eliminates the perceived surgical steps required for benefit but mimics the surgery in every other way. We examine whether an ethical framework might exist for sham surgeries to hypothetically be performed for clinical benefit of chronic pain. Once all evidence-based options are exhausted, performing sham surgeries may be justified under beneficence and non-maleficence since sham procedures are often equally efficacious but considerably safer than their true intervention counterparts. Physicians must only recommend such procedures with the intent of ameliorating patient suffering. Some degree of disclosure of a possible placebo effect prior to a sham surgery may satisfy the principle of autonomy while still maintaining the placebo response.

The Characteristics and Ethics of Sham Surgeries

“…So-called “sham” procedures serve as placebos by performing all the surgical steps except those thought to be therapeutically necessary 8 . They are proposed to produce placebo effects comparable to those reported in chemotherapeutic trials, whereby patients report symptomatic improvement after treatment with no therapeutically active ingredients 9,10 …”

“…8 They are proposed to produce placebo effects comparable to those reported in chemotherapeutic trials, whereby patients report symptomatic improvement after treatment with no therapeutically active ingredients. 9,10 Although trials involving sham procedures are theorized to reduce confounders, they are rarely studied. To date, a handful of studies have attempted to assess the risk-benefit profile of sham surgeries within particular fields, such as orthopedics and chronic pain, and two systematic reviews have evaluated the application across multiple fields.…”