Chronic Pain Trials considerations
Chronic Pain Trials are not easy to conduct: some relevant issues are discussed.
Chronic Pain Trials are fraught with difficulties.
Workshop 28 at the 6th International Congress on Neuropathic Pain (NeuPSIG 2017) in Goethenborg (Sweden), June: Improving the quality of pain trials Chair: Janne Gierthmühlen, Germany.
First presentation was on ‘Who is healthy? Aspects to consider when including healthy volunteers’ by Dr Janne Gierthmühlen, Germany. She pointed out many different definitions of ‘healthy’ and how this affects the population selected in pain trials. For pain studies it is important to the speaker to exclude depression and anxiety. But this was very much debated.
Design issues for chronic pain: importance of training in rating
ACTION collaboration was referred to. Selecting the primary endpoint is quite important. For instance in CIPN pain, tingling, numbness and cramping and biggest impact would be on positive symptoms. For instance numbness would not be of use to include, while burning pain would. Because primary outcome variables would need to be sensitive for therapy.
Excluding high base line variability in pain score. One could also train the patients to decrease their variability in scoring. Anchors for patients were helpful in more accurately rating their pain. Training also decrease placebo response as well as the variability in rating.
Subsequently the topic was ‘Research design considerations for chronic pain clinical trials’ by Dr. Jennifer Gewandter, USA. She was one of the architect of the topical ketamine-amitriptyline trial in neuropathic pain.
Considerations for outcome parameters in clinical pain trials: Is pain assessment a sufficient outcome parameter Robin Christensen, Denmark