ImmunoGlobulin administered SubCutaneously (SCIG) in Complex Regional Pain Syndrome (CRPS) over 12 months
| ISRCTN | ISRCTN63226217 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63226217 |
| EudraCT/CTIS number | 2009-015242-30 |
| Secondary identifying numbers | 2009-001 |
- Submission date
- 13/10/2010
- Registration date
- 10/03/2011
- Last edited
- 08/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Andreas Goebel
Scientific
Scientific
Pain Relief
Clincial Sciences Centre
The Walton Centre NHS Foundation Trust
Lower Lane
Liverpool
L9 7LJ
United Kingdom
| andreasgoebel@rocketmail.com |
Study information
| Study design | Open-label controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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) |
| Study acronym | SCIG in CRPS |
| Study objectives | 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). |
| Ethics approval(s) | Joint UCL/UCLH Ethics Committees of Human Research (Committee A), 24/09/2009, ref: 09/H0714/47 |
| Health condition(s) or problem(s) studied | Chronic Regional Pain Syndrome |
| Intervention | 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. The SCIG group receive: a priming dose at 1 g/kg of Sandoglobulin® NF Liquid or Privigen® (intraveneously). A maintenance dose of 1 g/kg/month of Vivaglobulin is divided into weekly amounts and given subcutaneously. After 6 months the dose may be reduced 0.5 g/kg/month. After 3 months, if patients' relief is maintained the dose is further reduced by half to 0.25 g/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 1 g/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. |
| Intervention type | Other |
| Primary outcome measure | 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 the end of treatment. |
| Secondary outcome measures | 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) |
| Overall study start date | 01/08/2010 |
| Completion date | 01/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 12 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2010 |
| Date of final enrolment | 01/08/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Pain Relief
Liverpool
L9 7LJ
United Kingdom
L9 7LJ
United Kingdom
Sponsor information
The Walton Centre NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Lower Lane
Fazakerley
Liverpool
L9 7LJ
England
United Kingdom
| Website | http://www.thewaltomcente.nhs.uk |
|---|---|
"ROR" |
https://ror.org/05cvxat96 |
Funders
Funder type
Industry
CSL Behring (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2013 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
