G90.5 G90.6 G90.7
Conditions
Interventions
Group 1: Cold and warm CRPS subtype
observation of pain and CRPS severity after steroid pulse
- Observation (10 weeks) before, during and after the steroid pulse of 2 weeks
- Thermography to determin
Sponsors
International Research Consortium for CRPS
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Meet the criteria above for Warm or Cold CRPS. • Upper or lower extremity CRPS restricted to a single limb. • Presence of secondary myofascial pain or pain not meeting CRPS criteria in other body regions are acceptable as long as the subjects meet full criteria for regional CRPS in a single limb (at PI’s discretion). • Duration of CRPS signs/symptoms of no less than 3 months and no more than 18 months from initial symptom onset. • For females of child bearing potential must agree to employ adequate birth control measures for the duration of the study • Patients agree to make no changes in treatment regimen (drug and non-drug) during the study except as advised and authorized by the PI/study site clinical team. • Average pain intensity in the past week of at least 4/10 on a Numeric Rating Scale (NRS; 0 = No Pain and 10 = Worst Possible Pain) administered during the phone screening (if applicable) and confirmed at the initial baseline visit. • Subjects must agree to clinic visits or weekly phone contact and data collection, and to adhere to the three times daily (morning, mid-day, evening) electronic pain diary assessment protocol.
Exclusion criteria
Exclusion criteria: • Subject has received an investigational drug, device or treatment within the six weeks prior to trial entry. • Bilateral or more than one region of CRPS • Concomitant medications that would confound study results (e.g., high dose opioids, greater than 50meq/day) at the discretion of the site PI. • Ongoing, severe and unaddressed mood disorder (e.g. depression, anxiety) as determined by the PI. If a subject’s psychological test scores reveal extreme psychological distress the subject may be withdrawn from the study or start of the study treatment protocol may be delayed until the psychological condition is adequately addressed at the discretion of the site PI • Individuals who have undergone a prior course of oral steroids less than 6 months prior to study entry. • Individuals experiencing significant problems during prior steroid exposure. • Individuals with contraindications for high dose oral steroid quick taper to low dose over 2 weeks. Examples include individuals with poorly controlled diabetes, osteopenia or gastric ulcer(s), Addison’s disease or other inherent or acquired corticoid disorder • Any individuals with contraindications to standard medical, physical and occupational therapy for CRPS. • Females only: Being pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease severity measured with the CRPS Severity Score (CSS) | — |
Secondary
| Measure | Time frame |
|---|---|
| NRS pain intensity and PROMIS 29-profile subclasses | — |
Countries
Germany, Netherlands, Switzerland, United States
Contacts
Public ContactHeike Rittner
Universitätsklinikum Würzburg
Outcome results
None listed