Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: A prospective two-center randomized controlled trial

Diabetes Care

Volumn 37, Issue 11, 2014, Pages 3016-3024

  Slangen, Rachel ^a   Schaper, Nicolaas C ^a   Faber, Catharina G ^a   Joosten, Elbert A ^a   Dirksen, Carmen D ^a,b   Van Dongen, Robert T ^c   Kessels, Alfons G ^a   Van Kleef, Maarten ^a,d  

^a MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

^b MAASTRICHT UNIVERSITY   (Netherlands)

^c RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^d VU UNIVERSITY AMSTERDAM   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT;

ADULT; ANALGESIA; ANTIBIOTIC THERAPY; ARTICLE; ASSESSMENT OF HUMANS; BEST MEDICAL TREATMENT; CLINICAL ARTICLE; CLINICAL EFFECTIVENESS; CONSERVATIVE TREATMENT; CONTROLLED STUDY; DAYTIME PAIN RELIEF; DEVICE INFECTION; DEVICE REMOVAL; DIABETIC NEUROPATHY; FEMALE; FOLLOW UP; HUMAN; LIMB PAIN; MALE; MEDICAL DEVICE COMPLICATION; MORTALITY; MULTICENTER STUDY; NEUROPATHIC PAIN SCALE; NIGHTTIME PAIN RELIEF; OUTCOME ASSESSMENT; PAIN ASSESSMENT; PAIN SEVERITY; PAINFUL DIABETIC PERIPHERAL NEUROPATHY; PATIENT GLOBAL IMPRESSION OF CHANGE SCALE; PERIPHERAL NEUROPATHY; POSTDURAL PUNCTURE HEADACHE; POSTOPERATIVE HEMORRHAGE; PROSPECTIVE STUDY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SLEEP QUALITY; SLEEP TIME; SPINAL CORD STIMULATION; SUBDURAL HEMATOMA; SURGICAL MORTALITY; TREATMENT DURATION; TREATMENT FAILURE; VISUAL ANALOG SCALE; AGED; CLINICAL TRIAL; DIABETIC NEUROPATHIES; LEG; MIDDLE AGED; PATHOPHYSIOLOGY; PROCEDURES; TREATMENT OUTCOME;

ADULT; AGED; DIABETIC NEUROPATHIES; FEMALE; HUMANS; LOWER EXTREMITY; MALE; MIDDLE AGED; PAIN MANAGEMENT; PROSPECTIVE STUDIES; SPINAL CORD STIMULATION; TREATMENT OUTCOME;

EID: 84910156860     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc14-0684     Document Type: Article

References (44)

1. Abbott CA, Malik RA, van Ross ERE, Kulkarni J, Boulton AJ. Prevalence and characteristics of painful diabetic neuropathy in a large community-based diabetic population in the U.K. Diabetes Care 2011;34:2220-2224
2. Daousi C, MacFarlane IA, Woodward A, Nurmikko TJ, Bundred PE, Benbow SJ. Chronic painful peripheral neuropathy in an urban community: a controlled comparison of people with and without diabetes. Diabet Med 2004;21:976-982
3. Davies M, Brophy S, Williams R, Taylor A. The prevalence, severity, and impact of painful diabetic peripheral neuropathy in type 2 diabetes. Diabetes Care 2006;29:1518-1522
4. Barrett AM, Lucero MA, Le T, Robinson RL, Dworkin RH, Chappell AS. Epidemiology, public health burden, and treatment of diabetic peripheral neuropathic pain: a review. Pain Med 2007;8(Suppl. 2):S50-S62
5. Dworkin RH, O'Connor AB, Audette J, et al. Recommendations for the pharmacological management of neuropathic pain: an overview and literature update. Mayo Clin Proc 2010; 85(Suppl.):S3-S14
6. Jensen TS, Backonja MM, Hernández Jiménez S, Tesfaye S, Valensi P, Ziegler D. New perspectives on the management of diabetic peripheral neuropathic pain. Diab Vasc Dis Res 2006;3:108-119
7. Snedecor SJ, Sudharshan L, Cappelleri JC, Sadosky A, Mehta S, Botteman M. Systematic review and meta-analysis of pharmacological therapies for painful diabetic peripheral neuropathy. Pain Pract 2014;14:167-184
8. Melzack R, Wall PD. Pain mechanisms: a new theory. Science 1965;150:971-979
9. Daousi C, Benbow SJ, MacFarlane IA. Electrical spinal cord stimulation in the long-term treatment of chronic painful diabetic neuropathy. Diabet Med 2005;22:393-398
10. de Vos CC, Rajan V, Steenbergen W, van der Aa HE, Buschman HP. Effect and safety of spinal cord stimulation for treatment of chronic pain caused by diabetic neuropathy. J Diabetes Complications 2009;23:40-45
11. Pluijms WA, Slangen R, Bakkers M, et al. Pain relief and quality-of-life improvement after spinal cord stimulation in painful diabetic polyneuropathy: a pilot study. Br J Anaesth 2012; 109:623-629
12. Tesfaye S, Watt J, Benbow SJ, Pang KA, Miles J, MacFarlane IA. Electrical spinal-cord stimulation for painful diabetic peripheral neuropathy. Lancet 1996;348:1698-1701
13. Kumar K, Toth C, Nath RK. Spinal cord stimulation for chronic pain in peripheral neuropathy. Surg Neurol 1996;46:363-369
14. Slangen R, Pluijms WA, Faber CG, Dirksen CD, Kessels AG, van Kleef M. Sustained effect of spinal cord stimulation on pain and quality of life in painful diabetic peripheral neuropathy. Br J Anaesth 2013;111:1030-1031
15. Bril V, England J, Franklin GM, et al.; American Academy of Neurology; American Association of Neuromuscular and Electrodiagnostic Medicine; American Academy of Physical Medicine and Rehabilitation. Evidence-based guideline: treatment of painful diabetic neuropathy: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation [published correction appears in Neurology 2011;77:603]. Neurology 2011;76:1758-1765
16. Feldman EL, Stevens MJ, Thomas PK, Brown MB, Canal N, Greene DA. A practical two-step quantitative clinical and electrophysiological assessment for the diagnosis and staging of diabetic neuropathy. Diabetes Care 1994;17:1281-1289
17. Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials:IMMPACT recommendations. J Pain 2008;9:105-121
18. Zelman DC, Gore M, Dukes E, Tai KS, Brandenburg N. Validation of a modified version of the Brief Pain Inventory for painful diabetic peripheral neuropathy. J Vasc Nurs 2005;23:97-104
19. Galer BS, Jensen MP. Development and preliminary validation of a pain measure specific to neuropathic pain: the Neuropathic Pain Scale. Neurology 1997;48:332-338
20. Kind P, Dolan P, Gudex C, Williams A. Variations in population health status: results from a United Kingdom national questionnaire survey. BMJ 1998;316:736-741
21. Dolan P, Roberts J. Modelling valuations for EQ-5D health states: an alternative model using differences in valuations. Med Care 2002;40:442-446
22. EuroQol Group. EuroQol - a new facility for the measurement of health-related quality of life. Health Policy 1990;16:199-208
23. Aaronson NK, Muller M, Cohen PD, et al. Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations. J Clin Epidemiol 1998;51:1055-1068
24. van der Zee K, Sanderman R, Heyink J. The psychometric qualities of the MOS 36-item short form survey in a Dutch population. Tijdschr Soc Gezondheidsz 1993;71:183-192 [in Dutch]
25. Viala-Danten M, Martin S, Guillemin I, Hays RD. Evaluation of the reliability and validity of the Medical Outcomes Study Sleep Scale in patients with painful diabetic peripheral neuropathy during an international clinical trial. Health Qual Life Outcomes 2008;6:113
26. Zelman DC, Brandenburg NA, Gore M. Sleep impairment in patients with painful diabetic peripheral neuropathy. Clin J Pain 2006;22:681-685
27. Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J. An inventory for measuring depression. Arch Gen Psychiatry 1961;4:561-571
28. Kumar K, Taylor RS, Jacques L, et al. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery 2008;63:762-770; discussion 770
29. 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
30. Farrar JT, Pritchett YL, RobinsonM, Prakash A, Chappell A. The clinical importance of changes in the 0 to 10 numeric rating scale for worst, least, and average pain intensity: analyses of data from clinical trials of duloxetine in pain disorders. J Pain 2010;11:109-118
31. Luo N, Johnson JA, Shaw JW, Feeny D, Coons SJ. Self-reported health status of the general adult U.S. population as assessed by the EQ-5D and Health Utilities Index. Med Care 2005; 43:1078-1086
32. Doth AH, Hansson PT, Jensen MP, Taylor RS. The burden of neuropathic pain: a systematic review and meta-analysis of health utilities. Pain 2010;149:338-344
33. Menzel P, Dolan P, Richardson J, Olsen JA. The role of adaptation to disability and disease in health state valuation: a preliminary normative analysis. Soc Sci Med 2002;55:2149-2158
34. Redelmeier DA, Rozin P, Kahneman D. Understanding patients' decisions. Cognitive and emotional perspectives. JAMA 1993;270:72-76
35. Ubel PA, Loewenstein G, Jepson C. Whose quality of life? A commentary exploring discrepancies between health state evaluations of patients and the general public. Qual Life Res 2003;12:599-607
36. Atkinson L, Sundaraj SR, Brooker C, et al. Recommendations for patient selection in spinal cord stimulation. J Clin Neurosci 2011;18: 1295-1302
37. Tesfaye S, Boulton AJ, Dickenson AH. Mechanisms and management of diabetic painful distal symmetrical polyneuropathy. Diabetes Care 2013;36:2456-2465
38. Eaton SEM, Harris ND, Rajbhandari SM, et al. Spinal-cord involvement in diabetic peripheral neuropathy. Lancet 2001;358:35-36
39. Selvarajah D, Wilkinson ID, Davies J, Gandhi R, Tesfaye S. Central nervous system involvement in diabetic neuropathy. Curr Diab Rep 2011;11:310-322
40. Selvarajah D, Wilkinson ID, Emery CJ, et al. Early involvement of the spinal cord in diabetic peripheral neuropathy. Diabetes Care 2006;29:2664-2669
41. Compton AK, Shah B, Hayek SM. Spinal cord stimulation: a review. Curr Pain Headache Rep 2012;16:35-42
42. Bendersky D, Yampolsky C. Is Spinal Cord Stimulation Safe? A Reviewof Its Complications. World Neurosurg. 11 July 2013 [Epub ahead of print]
43. Jeon YH. Spinal cord stimulation in pain management: a review. Korean J Pain 2012;25:143-150
44. Chiravuri S, Wasserman R, Chawla A, Haider N. Subdural hematoma following spinal cord stimulator implant. Pain Physician 2008;11:97-101