ISRCTN42179756已完成未知
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
niversity of Liverpool (UK)0 个研究点目标入组 108 人开始时间: 2013年6月28日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 108
研究概览
简要总结
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25344328 2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28973211 2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/29144634
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
相似试验
已完成
4 期
ymphocyte opioid receptors as innovative biomarkers for osteoarthritic chronic pain: study protocol for the assessment and risk management of opioid tailored therapy, before hip surgery, to prevent chronic pain and opioids tolerance/addiction developmentISRCTN12559751ISAL Foundation60
已完成
不适用
Assessing the clinical- and cost-effectiveness of facet-joint injections in selected patients with non-specific low back paiow back painMusculoskeletal DiseasesLow back painISRCTN12191542IHR Health Technology Assessment Programme - HTA (UK)150
已完成
不适用
A patient and carer shared management intervention for anorexiaMental and Behavioural DisordersAnorexia nervosaISRCTN14644379South London and Maudsley NHS Foundation Trust380
已完成
不适用
Cold oxygenated machine preservation of aged renal donation after cardiovascular death transplantsMachine perfusion preservation techniques of kidney graftsInjury, Occupational Diseases, PoisoningISRCTN32967929niversity of Oxford (UK)197
已完成
3 期
The British Antibiotic and Silver Impregnated Catheters for ventriculoperitoneal Shunts multi-centre randomised control trialHydrocephalusISRCTN49474281Alder Hey Children's Hospital Foundation Trust (UK)1,605