sympathetic reflex dystrophy
Conditions
Interventions
Treatment group: In the treatment group medication prescribed for CRPS is
tapered to zero. No invasive treatments like sympathetic blocks, and/or
operations will be performed. After extensive inform
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Protocol page 7: Problem definition;Adult patients (age 18-80 years) with CRPS-1 according to the diagnostic criteria list according to Bruehl/IASP for more than three months, but no longer than 2 years. Only patients with CRPS-1 in one extremity are included.
Exclusion criteria
Exclusion criteria: Patient known or suspected of not being able to comply with this study protocol or indication of reluctance to participate in the trial. Previous randomisation in this trial. Known presence of psychiatric disorder. Possible other cause of pain disorder (IASP criterium).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The Impairment level SumScore (ISS), which consists of three measurement parameters (pain, active range of motion and temperature) and four measurement instruments (VAS, McGill Pain Questionnaire, goniometry of mobility of joints and skin thermometer). 2. The functional disability of the arm, shoulder and hand (as measured by the DASH) or the legs (as measured by the Lower-Limb Task Questionnaire of McNair). 3. The behavior in pain (as determined by the Fear-Avoidance Beliefs Questionnaire (FABQ), a statement list regarding the perception on pain and physical activities). 4. The level of participation as determined by a subscale of the questionnaire SF36, which measures the patient*s point of view regarding health. A cost-effectiveness analysis from a societal perspective comparing PEPT to usual care in patients with CRPS will be performed. This will be done along-side the clinical trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 At function level, the muscle force measurements as derived from both hands by a handheld dynamometer and both feet (dorsal- en plantarflexion) by a mycrofet dynamometer. 2 At the level of activity limitations, for the arms the Radboud Skills Questionnaire; a questionnaire regarding two-handed activities of daily living) and for the legs the 10 meter walking test (which measures the time in walking a certain distance) and the timed up-and-go-test (which measures the time from rising from a chair and walking a restricted distance). | — |
Countries
Netherlands
Outcome results
None listed