By Jim Broatch.
November is CRPS Awareness Month and we asked the long-time Executive Director of the RSDSA to share with the National Pain Report his feelings on where their hard work is taking them.
I’m very optimistic about the current and prospects of the CRPS community.
For the past several years, RSDSA has been involved in creating the necessary infrastructure for an expected increase in CRPS international clinical trials. We have provided the seed and ongoing funding for the International Research Consortium (IRC) for CRPS.
The creation of the IRC was a prerequisite because although there have been significant strides in CRPS research during the last 20 years, there still is no solid information or Randomized Clinical Trials (RCTs) treatment or even definitive information about mechanisms and treatment responsive phenotype because:
- CRPS is a relatively rare condition and treatment trials have generally been small number (N) single site pilot studies. Federal agencies that approve treatment (e.g., FDA in the US) and insurance payers do not consider preliminary, pilot, or case series type evidence. Definitive trials are needed.
- Funding levels for basic and clinical research are at historic lows. (Remember that only 2% of research health care dollars are invested in pain research).
Large, multi-site studies with appropriate numbers are needed to advance research and the IRC will accomplish this through pooling of resources internationally for rapid and conclusive studies.
Since CRPS was designated as a rare disease (prevalence of less than 200,000 in the United States), a number of pharmaceutical and medical device manufacturers have signaled their intention of sponsoring CRPS clinical trials. Prior to this designation, I could only cite two major RCTs during the last twenty years. A number of corporations have approached me or members of our scientific advisory committee to discuss the feasibility of sponsoring trials now because CRPS has the rare disease moniker.
Currently, Grunenthal is sponsoring a clinical trial in the US of neridronic acid, to test its efficacy and safety in people with CRPS. Some individuals with CRPS have traveled to Italy to bypass the trial since individuals who have had CRPS for more two years are excluded from the trial.
The other part of the necessary infrastructure we are helping to fund is the finalization of COMPACT- Core Outcome Measures for Complex Regional Pain Syndrome Clinical Trials. Historically, a wide range of different outcome measures have been used to capture the multidimensional nature of CRPS which was a significant limiting factor in the advancement the understanding of the mechanisms and management of CRPS. In 2013, an international consortium of patients, clinicians, researchers and industry representatives was established to develop and agree on, a minimum core set of standardized patient reported outcome measures for use in future CRPS clinical studies in an adult population (COMPACT). This work was completed and published in 2017.
Now, RSDSA is funding the addition to COMPACT of an internationally agreed core clinical outcome measurement set that will be collected alongside the patient reported outcome measures and stored on an electronic data capture system.
Speaking with and corresponding daily with members of the RSDSA community, I’m heartened by the increased clinical use of medical cannabis, ketamine, low-dose naltrexone (LDN), and graded motor imagery (GMI) and mirror box therapy. But significant problems remain with the refusal of most insurers to pay for medical cannabis & ketamine and the lack of trained therapists in GMI.