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BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2011

Open Access 01-12-2011 | Study protocol

Effectiveness of anodal transcranial direct current stimulation in patients with chronic low back pain: Design, method and protocol for a randomised controlled trial

Authors: Kerstin Luedtke, Alison Rushton, Christine Wright, Tim P Juergens, Gerd Mueller, Arne May

Published in: BMC Musculoskeletal Disorders | Issue 1/2011

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Abstract

Background

Electrical stimulation of central nervous system areas with surgically implanted stimulators has been shown to result in pain relief. To avoid the risks and side effects of surgery, transcranial direct current stimulation is an option to electrically stimulate the motor cortex through the skull. Previous research has shown that transcranial direct current stimulation relieves pain in patients with fibromyalgia, chronic neuropathic pain and chronic pelvic pain. Evidence indicates that the method is pain free, safe and inexpensive.

Methods/Design

A randomised controlled trial has been designed to evaluate the effect of transcranial direct current stimulation over the motor cortex for pain reduction in patients with chronic low back pain. It will also investigate whether transcranial direct current stimulation as a prior treatment enhances the symptom reduction achieved by a cognitive-behavioural group intervention. Participants will be randomised to receive a series of 5 days of transcranial direct current stimulation (2 mA, 20 mins) or 20 mins of sham stimulation; followed by a cognitive-behavioural group programme. The primary outcome parameters will measure pain (Visual Analog Scale) and disability (Oswestry Disability Index). Secondary outcome parameters will include the Fear Avoidance Beliefs Questionnaire, the Funktionsfragebogen Hannover (perceived function), Hospital Anxiety Depression Scale, bothersomeness and Health Related Quality of Life (SF 36), as well as Patient-Perceived Satisfactory Improvement. Assessments will take place immediately prior to the first application of transcranial direct current stimulation or sham, after 5 consecutive days of stimulation, immediately after the cognitive-behavioural group programme and at 4 weeks, 12 weeks and 24 weeks follow-up.

Discussion

This trial will help to determine, whether transcranial direct current stimulation is an effective treatment for patients with chronic low back pain and whether it can further enhance the effects of a cognitive behavioural pain management programme. Trial registration: Current Controlled Trials ISRCTN89874874.
Appendix
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Literature
1.
Juniper M, Le TK, Mladsi D: The epidemiology, economic burden, and pharmacological treatment of chronic low back pain in France, Germany, Italy, Spain and the UK: a literature-based review. Expert Opin Pharmacother. 2009, 10 (16): 2581-2592. 10.1517/14656560903304063.CrossRefPubMed
2.
Wenig CM, Schmidt CO, Kohlmann T, Schweikert B: Costs of back pain in Germany. Eur J Pain. 2009, 13 (3): 280-286. 10.1016/j.ejpain.2008.04.005.CrossRefPubMed
3.
Apkarian AV, Sosa Y, Sonty S, Levy RM, Harden RN, Parrish TB, Gitelman DR: Chronic back pain is associated with decreased prefrontal and thalamic gray matter density. J Neurosci. 2004, 24 (46): 10410-10415. 10.1523/JNEUROSCI.2541-04.2004.CrossRefPubMed
4.
Schmidt-Wilcke T, Leinisch E, Ganssbauer S, Draganski B, Bogdahn U, Altmeppen J, May A: Affective components and intensity of pain correlate with structural differences in gray matter in chronic back pain patients. Pain. 2006, 125 (1-2): 89-97. 10.1016/j.pain.2006.05.004.CrossRefPubMed
5.
Flor H, Diers M, Birbaumer N: Peripheral and electrocortical responses to painful and non-painful stimulation in chronic pain patients, tension headache patients and healthy controls. Neurosci Lett. 1997, 224 (1): 5-8. 10.1016/S0304-3940(97)13441-3.CrossRefPubMed
6.
Flor H, Diers M: Sensorimotor training and cortical reorganization. NeuroRehabilitation. 2009, 25 (1): 19-27.PubMed
7.
Rodriguez-Raecke R, Niemeier A, Ihle K, Ruether W, May A: Brain gray matter decrease in chronic pain is the consequence and not the cause of pain. J Neurosci. 2009, 29 (44): 13746-13750. 10.1523/JNEUROSCI.3687-09.2009.CrossRefPubMed
8.
Tsao H, Galea MP, Hodges PW: Driving plasticity in the motor cortex in recurrent low back pain. Eur J Pain. 2010, 14 (8): 832-839. 10.1016/j.ejpain.2010.01.001.CrossRefPubMed
9.
Waddell G: The Back Pain Revolution. 2004, Edinburgh: Churchill Livingstone
10.
Coffey RJ: Deep brain stimulation for chronic pain: results of two multicenter trials and a structured review. Pain Med. 2001, 2 (3): 183-192. 10.1046/j.1526-4637.2001.01029.x.CrossRefPubMed
11.
Rasche D, Rinaldi PC, Young RF, Tronnier VM: Deep brain stimulation for the treatment of various chronic pain syndromes. Neurosurg Focus. 2006, 21 (6): E8-CrossRefPubMed
12.
Kumar K, Toth C, Nath RK: Deep brain stimulation for intractable pain: a 15-year experience. Neurosurgery. 1997, 40 (4): 736-746. 10.1097/00006123-199704000-00015. discussion 746-737CrossRefPubMed
13.
Tsubokawa T, Katayama Y, Yamamoto T, Hirayama T, Koyama S: Chronic motor cortex stimulation for the treatment of central pain. Acta Neurochir Suppl (Wien). 1991, 52: 137-139.CrossRef
14.
Velasco F, Arguelles C, Carrillo-Ruiz JD, Castro G, Velasco AL, Jimenez F, Velasco M: Efficacy of motor cortex stimulation in the treatment of neuropathic pain: a randomized double-blind trial. J Neurosurg. 2008, 108 (4): 698-706. 10.3171/JNS/2008/108/4/0698.CrossRefPubMed
15.
Trivedi B: Electrify Your Mind - Literally. New Scientist. 2006, 34-37. April 15
16.
Fregni F, Boggio PS, Lima MC, Ferreira MJ, Wagner T, Rigonatti SP, Castro AW, Souza DR, Riberto M, Freedman SD: A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. Pain. 2006, 122 (1-2): 197-209. 10.1016/j.pain.2006.02.023.CrossRefPubMed
17.
Soler MD, Kumru H, Pelayo R, Vidal J, Tormos JM, Fregni F, Navarro X, Pascual-Leone A: Effectiveness of transcranial direct current stimulation and visual illusion on neuropathic pain in spinal cord injury. Brain. 2010, 133 (9): 2565-2577. 10.1093/brain/awq184.CrossRefPubMedPubMedCentral
18.
Fregni F, Gimenes R, Valle AC, Ferreira MJ, Rocha RR, Natalle L, Bravo R, Rigonatti SP, Freedman SD, Nitsche MA: A randomized, sham-controlled, proof of principle study of transcranial direct current stimulation for the treatment of pain in fibromyalgia. Arthritis Rheum. 2006, 54 (12): 3988-3998. 10.1002/art.22195.CrossRefPubMed
19.
Valle A, Roizenblatt S, Botte S, Zaghi S, Riberto M, Tufik S, Boggio PS, Fregni F: Efficacy of anodal transcranial direct current stimulation (tDCS) for the treatment of fibromyalgia: results of a randomized, sham-controlled longitudinal clinical trial. J Pain Manag. 2009, 2 (3): 353-361.PubMedPubMedCentral
20.
Fenton BW, Palmieri PA, Boggio P, Fanning J, Fregni F: A preliminary study of transcranial direct current stimulation for the treatment of refractory chronic pelvic pain. Brain Stimul. 2009, 2 (2): 103-107. 10.1016/j.brs.2008.09.009.CrossRefPubMed
21.
Mori F, Codeca C, Kusayanagi H, Monteleone F, Buttari F, Fiore S, Bernardi G, Koch G, Centonze D: Effects of anodal transcranial direct current stimulation on chronic neuropathic pain in patients with multiple sclerosis. J Pain. 2009, 11 (5): 436-442.CrossRefPubMed
22.
Antal A, Terney D, Kuhnl S, Paulus W: Anodal transcranial direct current stimulation of the motor cortex ameliorates chronic pain and reduces short intracortical inhibition. J Pain Symptom Manage. 2010, 39 (5): 890-903. 10.1016/j.jpainsymman.2009.09.023.CrossRefPubMed
23.
Boggio PS, Amancio EJ, Correa CF, Cecilio S, Valasek C, Bajwa Z, Freedman SD, Pascual-Leone A, Edwards DJ, Fregni F: Transcranial DC stimulation coupled with TENS for the treatment of chronic pain: a preliminary study. Clin J Pain. 2009, 25 (8): 691-695. 10.1097/AJP.0b013e3181af1414.CrossRefPubMed
24.
Poreisz C, Boros K, Antal A, Paulus W: Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007, 72 (4-6): 208-214. 10.1016/j.brainresbull.2007.01.004.CrossRefPubMed
25.
Nitsche MA, Liebetanz D, Lang N, Antal A, Tergau F, Paulus W: Safety criteria for transcranial direct current stimulation (tDCS) in humans. Clin Neurophysiol. 2003, 114 (11): 2220-2222. 10.1016/S1388-2457(03)00235-9. author reply 2222-2223CrossRefPubMed
26.
Nitsche MA, Liebetanz D, Antal A, Lang N, Tergau F, Paulus W: Modulation of cortical excitability by weak direct current stimulation--technical, safety and functional aspects. Suppl Clin Neurophysiol. 2003, 56: 255-276.CrossRefPubMed
27.
Nitsche MA, Paulus W: Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001, 57 (10): 1899-1901.CrossRefPubMed
28.
Gandiga PC, Hummel FC, Cohen LG: Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol. 2006, 117 (4): 845-850. 10.1016/j.clinph.2005.12.003.CrossRefPubMed
29.
Bendix AF, Bendix T, Vaegter K, Lund C, Frolund L, Holm L: Multidisciplinary intensive treatment for chronic low back pain: a randomized, prospective study. Cleve Clin J Med. 1996, 63 (1): 62-69.CrossRefPubMed
30.
Dufour N, Thamsborg G, Oefeldt A, Lundsgaard C, Stender S: Treatment of chronic low back pain: a randomized, clinical trial comparing group-based multidisciplinary biopsychosocial rehabilitation and intensive individual therapist-assisted back muscle strengthening exercises. Spine (Phila Pa 1976). 2010, 35 (5): 469-476. 10.1097/BRS.0b013e3181b8db2e.CrossRef
31.
Lamb SE, Hansen Z, Lall R, Castelnuovo E, Withers EJ, Nichols V, Potter R, Underwood MR: Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis. Lancet. 2010, 375 (9718): 916-923. 10.1016/S0140-6736(09)62164-4.CrossRefPubMed
32.
Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, Bouter LM, de Vet HC: Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine (Phila Pa 1976). 2008, 33 (1): 90-94. 10.1097/BRS.0b013e31815e3a10.CrossRef
33.
34.
Fairbank JC, Couper J, Davies JB, O'Brien JP: The Oswestry low back pain disability questionnaire. Physiotherapy. 1980, 66 (8): 271-273.PubMed
35.
Mannion AF, Junge A, Fairbank JC, Dvorak J, Grob D: Development of a German version of the Oswestry Disability Index. Part 1: cross-cultural adaptation, reliability, and validity. Eur Spine J. 2006, 15 (1): 55-65. 10.1007/s00586-004-0815-0.CrossRefPubMed
36.
ten Klooster PM, Drossaers-Bakker KW, Taal E, van de Laar MA: Patient-perceived satisfactory improvement (PPSI): interpreting meaningful change in pain from the patient's perspective. Pain. 2006, 121 (1-2): 151-157. 10.1016/j.pain.2005.12.021.CrossRefPubMed
37.
Dunn KM, Croft PR: Classification of low back pain in primary care: using "bothersomeness" to identify the most severe cases. Spine (Phila Pa 1976). 2005, 30 (16): 1887-1892. 10.1097/01.brs.0000173900.46863.02.CrossRef
38.
Bergman S, Jacobsson LT, Herrstrom P, Petersson IF: Health status as measured by SF-36 reflects changes and predicts outcome in chronic musculoskeletal pain: a 3-year follow up study in the general population. Pain. 2004, 108 (1-2): 115-123. 10.1016/j.pain.2003.12.013.CrossRefPubMed
39.
Elliott TE, Renier CM, Palcher JA: Chronic pain, depression, and quality of life: correlations and predictive value of the SF-36. Pain Med. 2003, 4 (4): 331-339. 10.1111/j.1526-4637.2003.03040.x.CrossRefPubMed
40.
Ahrens C, Schiltenwolf M, Wang H: [Health-related quality of life (SF-36) in chronic low back pain and comorbid depression.]. Schmerz. 2010, 24 (3): 251-256. 10.1007/s00482-010-0923-1.CrossRefPubMed
41.
Bullinger M: German translation and psychometric testing of the SF-36 Health Survey: preliminary results from the IQOLA Project. International Quality of Life Assessment. Soc Sci Med. 1995, 41 (10): 1359-1366. 10.1016/0277-9536(95)00115-N.CrossRefPubMed
42.
Kohlmann T, Raspe H: [Hannover Functional Questionnaire in ambulatory diagnosis of functional disability caused by backache]. Rehabilitation (Stuttg). 1996, 35 (1): I-VIII.
43.
Waddell G, Newton M, Henderson I, Somerville D, Main CJ: A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993, 52 (2): 157-168. 10.1016/0304-3959(93)90127-B.CrossRefPubMed
44.
Pfingsten M, Kroner-Herwig B, Leibing E, Kronshage U, Hildebrandt J: Validation of the German version of the Fear-Avoidance Beliefs Questionnaire (FABQ). Eur J Pain. 2000, 4 (3): 259-266. 10.1053/eujp.2000.0178.CrossRefPubMed
45.
Staerkle R, Mannion AF, Elfering A, Junge A, Semmer NK, Jacobshagen N, Grob D, Dvorak J, Boos N: Longitudinal validation of the fear-avoidance beliefs questionnaire (FABQ) in a Swiss-German sample of low back pain patients. Eur Spine J. 2004, 13 (4): 332-340.CrossRefPubMedPubMedCentral
46.
Vlaeyen JW, Linton SJ: Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000, 85 (3): 317-332. 10.1016/S0304-3959(99)00242-0.CrossRefPubMed
47.
Leonhardt C, Lehr D, Chenot JF, Keller S, Luckmann J, Basler HD, Baum E, Donner-Banzhoff N, Pfingsten M, Hildebrandt J: Are fear-avoidance beliefs in low back pain patients a risk factor for low physical activity or vice versa? A cross-lagged panel analysis. Psychosoc Med. 2009, 6 (Doc01):
48.
Zigmond AS, Snaith RP: The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983, 67 (6): 361-370. 10.1111/j.1600-0447.1983.tb09716.x.CrossRefPubMed
49.
Kääpä EF, Sarna K, Malmivaara S: Multidisciplinary Group Rehabilitation Versus Individual Physiotherapy for Chronic Nonspecific Low Back Pain. Spine. 2008, 31 (4): 371-376.CrossRef
50.
51.
O'Connell NE, Wand BM, Marston L, Spencer S, DeSouza LH: Non-invasive brain stimulation techniques for chronic pain in adults (protocol). Cochrane Database Syst Rev (online). 2010
52.
Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, Schunemann HJ: GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008, 336 (7650): 924-926. 10.1136/bmj.39489.470347.AD.CrossRefPubMedPubMedCentral
53.
Melzack R: The short-form McGill Pain Questionnaire. Pain. 1987, 30 (2): 191-197. 10.1016/0304-3959(87)91074-8.CrossRefPubMed
54.
Exner V, Keel P: [Measuring disability of patients with low-back pain--validation of a German version of the Roland & Morris disability questionnaire]. Schmerz. 2000, 14 (6): 392-400. 10.1007/s004820070004.CrossRefPubMed
Metadata
Title
Effectiveness of anodal transcranial direct current stimulation in patients with chronic low back pain: Design, method and protocol for a randomised controlled trial
Authors
Kerstin Luedtke
Alison Rushton
Christine Wright
Tim P Juergens
Gerd Mueller
Arne May
Publication date
01-12-2011
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2011
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/1471-2474-12-290

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