Complex Regional Pain Syndrome (CRPS)
Conditions
Interventions
Trade Name: Sandoglobulin NF Liquid
Product Name: Sandoglobulin NF liquid
Product Code: IVIG-F10 (development name)
Pharmaceutical Form: Solution for in
Sponsors
The Walton Centre for Neurology and Neurosurgery NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: Patients will be suitable for consideration for screening and enrollment if they have received a diagnosis of CRPS according to the ‘Bruehl’ criteria1. In the first step, patients for the SCIG group will be chosen from patients who participated in a previous RCT in London and who responded better to IVIG than to normal saline. There are seven potential patients in that group, but one patient has a concomitant coagulatory problem and is not suitable for the priming intermediate dose treatment. Patients in either the SCIG or BMC group who agree to be invited for pre-screening will be reexamined by the principal investigator (PI) and, if still fulfilling the Bruehl criteria and the inclusion and exclusion criteria will be accepted for enrolment in the study. For the purpose of this trial, patients must be assumed to have at least a 24h average pain intensity of 6 over one week, with one day of a lower pain intensity of 5 acceptable. The patient’s pain intensity must be judged as stable by the PI. If a patient has concomitant medical conditions, then these must be judged as stable by the PI. Patients who wish not to follow recommendations of the Trial Team as to receiving concomitant treatment according to best medical care will nevertheless be suitable for enrollment. For each SCIG patient who successfully passes the screening and assessment of the first treatment and is enrolled into the trial, two patients matched to age +/- 10 years, sex, average 24h pain intensity and acute limb activity related pain intensity +/- 2 points (but not below 5 on the NRS) and disease duration +/- 18 months, will be selected for screening from those patients seen at the Walton Centre over the prior 18 months. It should be ensured that patients in both groups have used routine medications before enrollment including gabapentin and/or pregabalin, duloxetin and/or venlaflaxine, a tricyclic antidepressant, lignocaine patches, both a strong and weak opioid in an appropriate dose without sufficient benefit. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria All patients in the SCIG group have already been tested for their IgA serum levels which were normal in all cases. Patients with progressive renal failure, and any patient requiring IVIG for another disorder are excluded. Treatment will be deferred in patients with an infection such as cold, flu or infected pressure sores until the infection has resolved, because IG is contraindicated in cases of untreated bacterial infection. Further, patients in both groups are excluded, should they: • Have evidence of significant organic disease on history or physical examination, which may be severe enough to prevent the patient from being able to complete the study. • Suffer from another severe chronic pain syndrome such as fibromyalgia which may in the judgement of principle investigator hinder the appropriate assessment of pain from CRPS • Have a history of abuse or are currently abusing alcohol or drugs [using DSM-IV criteria]. • Have a psychiatric disorder which may in the judgement of the site investigator interfere with successful study participation. • Are unwilling or not able to complete daily diaries • Do not understand the psychological questionnaires because appropriate validated translations into the patient’s language are not available For the following patients in the SCIG group suitability for participation needs to be discussed with a specialist consultant: • Patients with compensated renal failure, patients suffering from epilepsy • Patients with a history of stroke or myocardial infarction • Patients with a known pro-coagulatory or blood-hyperviscosity disorder - Patients on loop diuretics • Patients with cancer other than basal cell carcinoma within the last 5 years. Those patients who have received definite treatment, such as curative surgery, with no known recurrence can be included without further discussion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To ascertain the efficacy of repeated doses over one year of immune modulation treatment with a subcutaneous preparation of immunoglobulins (SCIG) in patients who had pain relief after a single dose intravenous immunoglobulin treatment.; Secondary Objective: To determine using quantitative Sensory Testing (QST) whether and how much evoked pain and sensory thresholds are normalised following SCIG therapy. To assess the effectiveness of SCIG given over one year using measures of function, quality of life and return to work To find out using qualitative interviews whether and to what extent appropriate psychosocial measures designed to maximise effectiveness are indicated. To compare the efficacy and effectiveness of SCIG and BMC with BMC only To provide a cost effectiveness estimate for SCIG in terms of Quality Adjusted Life Years (QALY) To find out whether serum-autoantibodies can predict responsiveness to IVIG ;Primary end point(s): Pain measured on a 0-11 Numerical Rating Scale. The primary outcome will be changes in the mean pain score over a two week period at baseline compared to mean pain score over a two week period at end of treatment. | — |
Countries
United Kingdom
Outcome results
None listed