Low-dose intravenous immunoglobulin treatment for complex regional pain syndrome (LIPS): Study protocol for a randomized controlled trial

Trials

Volumn 15, Issue 1, 2014, Pages

  Goebel, Andreas ^a   Shenker, Nicholas ^b   Padfield, Nick ^c   Shoukrey, Karim ^d   McCabe, Candida ^e   Serpell, Mick ^f   Sanders, Mark ^g   Murphy, Caroline ^h   Ejibe, Amaka ^h   Milligan, Holly ^a   Kelly, Joanna ^h   Ambler, Gareth ⁱ  

^a UNIVERSITY OF LIVERPOOL   (United Kingdom)

^b ADDENBROOKE S HOSPITAL   (United Kingdom)

^c GUY'S AND ST THOMAS' NHS FOUNDATION TRUST   (United Kingdom)

^d UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST   (United Kingdom)

^e UNIVERSITY OF THE WEST OF ENGLAND   (United Kingdom)

^f GARTNAVEL GENERAL HOSPITAL   (United Kingdom)

^g NORFOLK AND NORWICH UNIVERSITY HOSPITAL   (United Kingdom)

^h KING'S COLLEGE LONDON   (United Kingdom)

ⁱ UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

CRPS; immunoglobulin; IVIg; pain

Indexed keywords

IMMUNOGLOBULIN; PLACEBO; ANALGESIC AGENT;

ACUTE KIDNEY FAILURE; ADVERSE OUTCOME; ANAPHYLAXIS; ANGINA PECTORIS; ARTHRALGIA; ARTICLE; ASEPTIC MENINGITIS; BACKACHE; BLOOD SAMPLING; CEREBROVASCULAR ACCIDENT; CHILL; CLINICAL EFFECTIVENESS; COMPLEX REGIONAL PAIN SYNDROME; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DISEASE DURATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; ECONOMIC EVALUATION; EVOKED RESPONSE; FEMALE; FEVER; HEADACHE; HEART INFARCTION; HEMOLYSIS; HEMOLYTIC ANEMIA; HUMAN; HYPERSENSITIVITY; HYPOTENSION; LOW DRUG DOSE; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NAUSEA; OUTCOME ASSESSMENT; PAIN ASSESSMENT; PAIN INTENSITY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RIGOR; RISK ASSESSMENT; RISK FACTOR; SHOCK; SKIN MANIFESTATION; TREATMENT RESPONSE; UNITED KINGDOM; VOMITING; CLINICAL PROTOCOL; CLINICAL TRIAL; COMPLEX REGIONAL PAIN SYNDROMES; METHODOLOGY; PAIN MEASUREMENT; SEVERITY OF ILLNESS INDEX; TIME; TREATMENT OUTCOME;

ANALGESICS; CLINICAL PROTOCOLS; COMPLEX REGIONAL PAIN SYNDROMES; DOUBLE-BLIND METHOD; GREAT BRITAIN; HUMANS; IMMUNOGLOBULINS, INTRAVENOUS; PAIN MEASUREMENT; RESEARCH DESIGN; SEVERITY OF ILLNESS INDEX; TIME FACTORS; TREATMENT OUTCOME;

EID: 84934754922     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-15-404     Document Type: Article

References (26)

1. Goebel A: Complex regional pain syndrome in adults. Rheumatology (Oxford) 2011, 50:1739-1750. 10.1093/rheumatology/ker202
2. Marinus J, Moseley GL, Birklein F, Baron R, Maihofner C, Kingery WS, van Hilten JJ: Clinical features and pathophysiology of complex regional pain syndrome. Lancet Neurol 2011, 10:637-648. 10.1016/S1474-4422(11)70106-5.
3. Forouzanfar T, Koke AJ, van Kleef M, Weber WE: Treatment of complex regional pain syndrome type I. Eur J Pain 2002, 6:105-122. 10.1053/eujp.2001.0304.
4. Kemler MA, Furnee CA: Economic evaluation of spinal cord stimulation for chronic reflex sympathetic dystrophy. Neurology 2002, 59:1203-1209. 10.1212/01.WNL.0000028686.74056.E3.
5. Goebel A: Immunoglobulin responsive chronic pain. J Clin Immunol 2010,30(Suppl 1):S103-S108.
6. Goebel A, Netal S, Schedel R, Sprotte G: Human pooled immunoglobulin in the treatment of chronic pain syndromes. Pain Med 2002, 3:119-127. 10.1046/j.1526-4637.2002.02018.x.
7. Goebel A, Stock M, Deacon R, Sprotte G, Vincent A: Intravenous immunoglobulin response and evidence for pathogenic antibodies in a case of complex regional pain syndrome 1. Ann Neurol 2005, 57:463-464. 10.1002/ana.20400.
8. Goebel A, Baranowski AP, Maurer K, Ghiai A, McCabe C, Ambler G: Intravenous immunoglobulin treatment of complex regional pain syndrome: a randomized trial. Ann Intern Med 2010, 152:152-158. 10.7326/0003-4819-152-3-201002020-00006.
9. Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, et al.: Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain 2005, 113:9-19. 10.1016/j.pain.2004.09.012.
10. Brooks R: EuroQol: the current state of play. Health Policy 1996, 37:53-72. 10.1016/0168-8510(96)00822-6.
11. Tan G, Jensen MP, Thornby JI, Shanti BF: Validation of the brief pain inventory for chronic nonmalignant pain. J Pain 2004, 5:133-137. 10.1016/j.jpain.2003.12.005.
12. Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X: Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011, 20:1727-1736. 10.1007/s11136-011-9903-x.
13. Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB, Cowan P, Farrar JT, Hertz S, Raja SN, Rappaport BA, Rauschkolb C, Sampaio C: Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain 2009, 146:238-244. 10.1016/j.pain.2009.08.019.
14. Cappelleri JC, Bushmakin AG, McDermott AM, Sadosky AB, Petrie CD, Martin S: Psychometric properties of a single-item scale to assess sleep quality among individuals with fibromyalgia. Health Qual Life Outcomes 2009, 7:54. 10.1186/1477-7525-7-54.
15. Wasan AD, Kong J, Pham LD, Kaptchuk TJ, Edwards R, Gollub RL: The impact of placebo, psychopathology, and expectations on the response to acupuncture needling in patients with chronic low back pain. J Pain 2010, 11:555-563. 10.1016/j.jpain.2009.09.013.
16. Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole RM: Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001, 94:149-158. 10.1016/S0304-3959(01)00349-9.
17. Zigmond AS, Snaith RP: The hospital anxiety and depression scale. Acta Psychiatr Scand 1983, 67:361-370. 10.1111/j.1600-0447.1983.tb09716.x.
18. Dworkin RH, Turk DC, Revicki DA, Harding G, Coyne KS, Peirce-Sandner S, Bhagwat D, Everton D, Burke LB, Cowan P, Farrar JT, Hertz S, Max MB, Rappaport BA, Melzack R: Development and initial validation of an expanded and revised version of the short-form McGill pain questionnaire (SF-MPQ-2). Pain 2009, 144:35-42. 10.1016/j.pain.2009.02.007.
19. Sullivan LJ, Bishop SR, Pivik J: The pain catastrophizing scale: development and validation. Psychologial Assessment 1995, 7:524-532.
20. Koopman C, Pelletier KR, Murray JF, Sharda CE, Berger ML, Turpin RS, Hackleman P, Gibson P, Holmes DM, Bendel T: Stanford presenteeism scale: health status and employee productivity. J Occup Environ Med 2002, 44:14-20. 10.1097/00043764-200201000-00004.
21. Frettlöh J, Hüppe M, Maier C: Severity and specificity of neglect-like symptoms in patients with complex regional pain syndrome (CRPS) compared to chronic limb pain of other origins. Pain 2006,124(1-2):184-189. Epub 2006 May 30 10.1016/j.pain.2006.04.010.
22. Harden RN, Bruehl S, Stanton-Hicks M, Wilson PR: Proposed new diagnostic criteria for complex regional pain syndrome. Pain Med 2007, 8:326-331. 10.1111/j.1526-4637.2006.00169.x.
23. Dworkin RH, O'Connor AB, Backonja M, Farrar JT, Finnerup NB, Jensen TS, Kalso EA, Loeser JD, Miaskowski C, Nurmikko TJ, Portenoy RK, Rice AS, Stacey BR, Treede RD, Turk DC, Wallace MS: Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain 2007, 132:237-251. 10.1016/j.pain.2007.08.033.
24. Oerlemans HM, Oostendorp RA, de Boo T, Goris RJ: Pain and reduced mobility in complex regional pain syndrome I: outcome of a prospective randomised controlled clinical trial of adjuvant physical therapy versus occupational therapy. Pain 1999, 83:77-83. 10.1016/S0304-3959(99)00080-9.
25. Melzack R: The short-form McGill pain questionnaire. Pain 1987, 30:191-197. 10.1016/0304-3959(87)91074-8.
26. Machin D, Campbell MJ, Tan SB, Tan SH: Sample size tables. 3rd edition. 2008.