CRPS-RISE Outcomes Registry

Average pain (24-hour recall) reported on an 11-point numeric rating scale. This is recorded every 90 days from entry.

Each patient reported registry assessment of average pain in the past 24 hours will use an 11 point numeric rating scale. The analysis will be limited to participants who experienced benefit. Data will be summarized as Kaplan-Meier estimates.

The CSS-SR is designed as a patient self-report questionnaire to assess the severity of CRPS signs and symptoms using plain language to assess 13 concepts.

The 6-point PGI-S is an overall assessment of the participant's perception of the severity of their CRPS condition at the time of the assessment. Participants will respond to the question "How would you rate the symptoms of your CPRS at this time." Possible responses are scored from 0 to 5 representing none, minimal, mild, moderate, severe, very severe.

The SF-12 is a widely used measure of general health status used in observational studies across a broad range of disease areas. It is a shortened version of the SF-36 V2.0 and yields 8 domain scores and a Physical Component Summary and Mental Component Summary. Each domain score is calculated by transforming raw responses to a 0-100 scale, where higher scores indicate better health status.

The DSIS is a single-item scale that assesses "how much did your pain interfere with your sleep during the past 24 hours?" (0 = did not interfere; 10 = completely interfered

The CRPS-1 Treatment Checklist was developed for this registry to assess commonly used pharmacologic treatments (e.g., opioids, neuropathic pain agents, ketamine, NSAIDs, bisphosphonates, corticosteroids, and topicals),interventional procedures (e.g., spinal cord or dorsal root ganglion stimulation, peripheral nerve stimulation, stellate/lumbar sympathetic blocks, sympathetic ablation/sympathectomy, intrathecal pump implant, and Bier block), and non-invasive rehabilitation therapies (e.g., physical therapy, occupational therapy, mirror visual feedback, psychological therapies, scrambler therapies or acupuncture). Participants select all CRPS-related treatments used in the past 3 months. The checklist will also record participation in the open-label clinical trial and is intended for descriptive evaluation of long-term CRPS-1 treatments with a focus on resource intensive events. The outcome domain assesses the long-term effectiveness of neridronate through patient reports.

During the 3 months preceding each registry assessment the participant reported applying for or being on short-term disability, long-term disability, or workers compensation. As a binary endpoint, it will be summarized as frequencies and percentages. The domain assesses the long-term effectiveness of neridronate through patient reports of short-term disability, long-term disability, and workers compensation.

The potential for inclusion of linked health care claims and electronic health record data will be enabled by having participants consent to tokenizing their identifying information.