Low-dose intravenous immunoglobulin treatment for Complex Regional Pain Syndrome

• Register: ISRCTN
• Last refreshed on: 14 January 2019
• Main ID: ISRCTN42179756
• Date of registration: 28/06/2013
• Prospective Registration: Yes
• Primary sponsor: University of Liverpool (UK)
• Public title: Low-dose intravenous immunoglobulin treatment for Complex Regional Pain Syndrome
• Scientific title: A multi-centre (UK) double-blind randomised parallel group placebo controlled trial to evaluate the efficacy, safety, and tolerability of Intravenous Immunoglobulin (IVIg) 0.5g/kg plus standard treatment, versus matched placebo plus standard treatment in patients with long standing Complex Regional Pain Syndrome
• Date of first enrolment: 15/08/2013
• Target sample size: 108
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN42179756
• Study type: Interventional
• Study design: Double-blind randomised parallel placebo-controlled trial; Interventional; Design type: Treatment (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Caroline Murphy

Key inclusion & exclusion criteria

Inclusion criteria:
1. Diagnosis of CRPS I or II according to Budapest research criteria (appendix 3) (15).
2. Disease duration of 1-5 years and a mean pain intensity on an 11-point (0-10) Numeric Rating Scale (NRS) over the first seven daily entries after screening within a pre-defined range (see section 9 for details of pain thresholds for eligibility).
3. Failure to respond (poor efficacy or unacceptable side effects) to drugs recommended for the treatment of neuropathic pain (16), including pregabalin or gabapentin, a tricyclic antidepressant, and mild and strong opioids (where not contraindicated or refused by the patient).
4. Previous specialised pain physiotherapy (17), including desensitisation techniques, and either mirror therapy (18) or graded motor imagery treatment (19), or both (where not contraindicated or refused by the patient).
5. Willingness to confirm the use of adequate birth control while on the trial will be required in pre-menopausal women without evidence for an inability to become pregnant.
6. Willingness to not start any other treatment for CRPS during the parallel part of the trial.
7. Age 18 years and above; Target Gender: Male & Female

Exclusion criteria:
1. Other significant chronic pains, which in the view of the study doctor may make assessment of the pain arising from CRPS difficult.
2. If the patient recently started a new therapy for CRPS, which in the view of the study doctor may change the patient?s pain level during the time of participation in the trial.
3. Unstable medical conditions.
4. Litigation. Patients in litigation will be excluded only if conclusion of that litigation is imminent during the course of the study.
5. Pregnant or breastfeeding patients.
6. Less than half of the lower limit of the normal serum IgA level given by the respective trials unit laboratory
7. Rare contraindications to IVIg therapy as per summary of product characteristics (SmPC)
8. Receiving IVIg for other reasons,
9. Patients previously enrolled in CRPS IVIg/SCIG trials
10. Drugs or alcohol abuse
11. Psychiatric or mental health disorder which could in the judgement of the site investigator interfere with successful study participation
12. Unwillingness or inability to complete daily diaries, or inability to understand the questionnaires being used.
13. Cancer other than basal cell carcinoma within the last 5 years. However, those patients who have received definitive treatment, such as curative surgery more than 6 months ago, with no known recurrence can be included.
14. A history of hypercoagulable or thrombophilic clotting abnormalities.
15. A history of thrombembolic events: ischaemic stroke, confirmed myocardial infarction, pulmonary embolism; deep venous thrombosis except where immobility related (e.g., after injury or operation).
16. Renal failure, or serum creatinine greater than 1.5 times the upper limit of normal at screening
17. Any medical condition which in the opinion of the investigator would make it unsafe for the patient to participate or which would interfere with assessment of the outcome measures.


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Anaesthetics, Complex Regional Pain Syndrome
Nervous System Diseases
Causalgia

Intervention(s)

The experimental intervention is 0.5 g/kg IntratectTM IVIg infusion, in combination with ongoing normal standard treatment for Complex Regional Pain Syndrome.

Primary Outcome(s)

Added 26/01/2016:
The average 24h pain intensity over 37 days, recorded in pain diary entries for the previous 24 hours collected on days 6 to 42 (day 1=day of first infusion)

Secondary Outcome(s)

Added 26/01/2016:
1. Pain interference measured using the interference subscale of the Brief Pain Inventory at days 22 and 43
2. Quality of life measured using the Euroqol EQ-5D-5L at days 22 and 43
All other outcomes are exploratory.

Secondary ID(s)

12715

2012-000058-73

Source(s) of Monetary Support

Biotest UK Ltd, NIHR (UK) - Efficacy and Mechanism Evaluation; Grant Codes: 11/14/33, Pain Relief Foundation (UK)

Ethics review

Status:
Approval date:
Contact:

East of England Hatfield REC (formerly known as NRES Committee East of England ? Welwyn), 06/06/2013, ref:12/EE/0164

Results

• Results available: Yes
• Date Completed: 30/11/2015