CRPS-RISE Outcomes Registry

Change from baseline to each registry assessment of average pain in the past 24 hours.

Time frame: Every 3 months from enrollment until up to 2 years after entry.

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

Time to loss of benefit where benefit is 50% reduction in average pain intensity from baseline to Week 12 of the CRPS-RISE trial.

Time frame: Every 3 months from enrollment until up to 2 years after 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.

Change from baseline to each registry assessment in CRPS Severity Score Self-Report (CSS-SR) total score and individual items.

Time frame: Every 3 months from entry to up to 24 months of participation.

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.

Change from baseline to each registry assessment in Patient Global Impression of Severity (PGI-S).

Time frame: Every 3 months from enrollment until up to 2 years after entry.

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.

Change from baseline to each registry assessment in each of the Short Form 12 Health Survey (SF-12, Acute Version 2) domains, Physical Component Score (PCS), Mental Component Score (MCS), and individual items.

Time frame: Every 3 months from enrollment until up to 2 years after entry.

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.

Change from baseline to each registry assessment in Daily Sleep Interference Scale (DSIS) in the past 24 hours on an 11-point numeric rating scale.

Time frame: Every 3 months from enrollment until up to 2 years after entry.

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

CRPS-1 Related Clinical Events during the 3 months preceding each registry assessment.

Time frame: Every 3 months from enrollment until up to 2 years after entry.

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.

Disability Status

Time frame: Every 3 months from enrollment until up to 2 years after entry.

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.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.