ImmunoGlobulin administered SubCutaneously (SCIG) in Complex Regional Pain Syndrome (CRPS) over 12 months

Completed

• Conditions: Chronic Regional Pain Syndrome; Not Applicable

• Registration Number: ISRCTN63226217
• Lead Sponsor: The Walton Centre NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-10
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Intervention group:
1.1. Diagnosis of CRPS according to the 'Bruehl' criteria
1.2. Recruited from a previous RCT in London, responding better to intravenous immunoglobulin (IVIG) than normal saline
1.3. At least a 24h average pain intensity of 6 over one week (one day of a lower pain intensity of 5 acceptable). Pain intensity must be judged as stable by the principal investigator (PI)
1.4. Patients and matched controls should 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.
1.5. 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.
1.6. Aged 18 years or over

2. Control group:
2.1. Selected from patients seen at the Walton Centre over the prior 18 months
2.2. Matched for:
2.2.1. Age +/10 years
2.2.2. Sex
2.2.3. Average 24 h pain intensity and acute limb activity related pain intensity +/2 points (but not below 5 on the NRS)
2.2.4. Disease duration +/18 months

Exclusion Criteria

1. All patients (cases and controls):
1.1. 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
1.2 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
1.3 Have a history of abuse or are currently abusing alcohol or drugs [using DSMIV criteria]
1.4. Have a psychiatric disorder which may in the judgement of the site investigator interfere with successful study participation
1.5. Are unwilling or not able to complete daily diaries
1.6. Do not understand the psychological questionnaires because appropriate validated translations into the patient's language are not available

2. Intervention group:
2.1. IgA serum levels within normal ranges. All patients in the SCIG group have already been tested for their IgA serum levels which were normal in all cases.
2.2. Patients with progressive renal failure and any patient requiring IVIG for another disorder
2.3. 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
2.4. For the following patients in the SCIG group suitability for participation needs to be discussed with a specialist consultant:
2.4.1. Patients with compensated renal failure, patients suffering from epilepsy
2.4.2. Patients with a history of stroke or myocardial infarction
2.4.3. Patients with a known procoagulatory or bloodhyperviscosity disorder
2.4.4. Patients on loop diuretics
2.4.5. 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified