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| [ ...Back to search results ] | [ Print-friendly version ] |
| ImmunoGlobulin administered SubCutaneously (SCIG) in Complex Regional Pain Syndrome (CRPS) over 12 months |
| ISRCTN | ISRCTN63226217 |
| ClinicalTrials.gov identifier | |
| Public title | ImmunoGlobulin administered SubCutaneously (SCIG) in Complex Regional Pain Syndrome (CRPS) over 12 months |
| Scientific title | An open study to compare the efficacy of ImmunoGlobulin administered SubCutaneoulsy (SCIG) with current best practice in patients with Complex Regional Pain Syndrome (CRPS) |
| Acronym | SCIG in CRPS |
| Serial number at source | 2009-001 |
| Study hypothesis |
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.
Please note that the participants of this trial have all taken part in a previous trial entitled: ‘Clinical response to intravenous immunoglobulin inpatients with complex regional pain syndrome (CRPS)’ (see http://www.controlled-trials.com/ISRCTN63918259 for the ISRCTN record of this trial). |
| Lay summary | |
| Ethics approval | Joint UCL/UCLH Ethics Committees of Human Research (Committee A) approved on the 24 September 2009 (ref: 09/H0714/47) |
| Study design | Open label controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Chronic Regional Pain Syndrome |
| Participants - 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 24h 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 |
| Participants - 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. |
| Anticipated start date | 01/08/2010 |
| Anticipated end date | 01/08/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 12 |
| Interventions |
There are two groups. One gets SCIG and usual care (we call it best medical care, BMC) the other gets BMC only. Treatment duration is 12 months with follow ups at 18 and 24 months.
SCIG group receive: a priming dose at 1g/kg of Sandoglobulin® NF Liquid or Privigen®(intraveneously). A maintenance dose of 1g/kg/month of Vivaglobulin is divided into weekly amounts and given subcutaneously. After 6 months the dose may be reduced 0.5g/kg/month. After three months, if patients relief is maintained the dose is further reduced by half to 0.25g/kg/month for the remainder of the study (up to 12 months). Should patients experience increased pain following the dose reduction, the previous higher dose will be reinstated (0.5 or 1g/kg/month). BMC is recorded and monitored throughout. It is not possible to detail this as its dependent on patients previous and current treatments but may include physiotherapy, occupational therapy, psychology, pain management programme. |
| Primary outcome measure(s) | Pain measured on a 0-10 Numerical Rating Scale. 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. |
| Secondary outcome measure(s) |
1. Quantitative Sensory Testing (QST) values before versus after treatment and after a continuous period of treatment, including sensory thresholds and allodynia values.
2. 0-10 Numerical Rating Scale for Pain (NRS) assessed daily throughout the study 3. Questionnaire booklet: Completed monthly throughout the study to assess pain related functioning, mood, quality of life and illness perceptions using the following validated questionnaires: 2.1. Brief Pain Inventory (BPI) 2.2. EuroQol-5D 2.3. Illness Perception Questionnaire (IPQ) 2.4. Tampa Scale for Kinesaphobia (TSK) 2.5. Pain Catastrophising Scale (PCS) 2.6. Perceived Adjustment to Chronic Illness Scale (PACIS) coping scale 2.7. Hospital Anxiety and Depression Scale (HADS) |
| Sources of funding | CSL Behring (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Andreas Goebel |
| Address |
Pain Relief
Clincial Sciences Centre The Walton Centre NHS Foundation Trust Lower Lane |
| City/town | Liverpool |
| Zip/Postcode | L9 7LJ |
| Country | United Kingdom |
| andreasgoebel@rocketmail.com | |
| Sponsor | The Walton Centre NHS Foundation Trust (UK) |
| Address |
Lower Lane
Fazakerley |
| City/town | Liverpool |
| Zip/Postcode | L9 7LJ |
| Country | United Kingdom |
| Sponsor website: | http://www.thewaltomcente.nhs.uk |
| Date applied | 13/10/2010 |
| Last edited | 17/03/2011 |
| Date ISRCTN assigned | 10/03/2011 |
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| © 2012 ISRCTN unless otherwise stated. | |
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