Managing Chronic Regional Pain Syndrome: The Potential Impact of the Food and Drug Omnibus Reform Act

Abstract

Complex regional pain syndrome (CRPS) is a neurological disorder characterized by persistent limb symptoms. With there being no definitive tests, diagnosis can be challenging. The Budapest criteria are the standard for diagnosis. The underlying mechanisms of CRPS involve changes in skin innervation, sensitization of the nervous system, inflammatory cytokines, and genetic and psychological factors. Treatment typically involves a multidisciplinary approach. We present a case of a 71-year-old male with CRPS involving the right upper extremity and a complex history of management including physical therapy, oxycodone, muscle relaxers, non-steroidal anti-inflammatory drugs, and multiple stellate ganglion blocks. The patient manages his pain with off-label medications, including methadone, duloxetine, and pregabalin. In the United States, the management of chronic pain may be affected by potential usage restrictions imposed by the Food and Drug Omnibus Reform Act (FDORA). Under this new act, physicians may face limitations in prescribing off-label medications for specific diagnoses. We aim to highlight the need for prioritizing patient care and individualized treatment in healthcare policy decision-making.

Keywords: budapest criteria; chronic pain; chronic regional pain syndrome; food and drug omnibus reform act; off-label treatments; type 1 crps; upper extremity injury.

Figure 1. Budapest criteria for complex regional pain syndrome (CRPS) diagnosis

Adapted from [9].

Figure 2. CRPS severity score (CSS)

The maximum CSS score is 16. Each symptom and sign is assigned a score of 1 for assessment. Higher scores indicate greater CRPS severity. Lower scores indicate lesser CRPS severity [11]. CRPS: complex regional pain syndrome.