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The influence of a non-invasive electrical stimulation over an area of the brain on pain and disability in patients with long-standing back pain
ISRCTN ISRCTN89874874
DOI 10.1186/ISRCTN89874874
ClinicalTrials.gov identifier
EudraCT number
Public title The influence of a non-invasive electrical stimulation over an area of the brain on pain and disability in patients with long-standing back pain
Scientific title Effectiveness of anodal transcranial direct current stimulation (tDCS) in patients with chronic low back pain: a randomised controlled trial
Acronym N/A
Serial number at source N/A
Study hypothesis The objectives of this study are to assess:
1. The effect of tDCS (5 consecutive days, once a day, 20 minutes, 2mA) on perceived pain intensity and disability of patients with non-specific CLBP (duration greater than 3 months)
2. The effect of tDCS given prior to a cognitive-behavioural group programme (standard care) on perceived pain and disability at the end of the programme
Lay summary
Ethics approval 1. Germany: Ethik-Kommission der Aerztekammer Hamburg approved on the 4th January 2010 (ref: PV3297). An amendment was approved on the 7th July 2010.
2. UK: Research Ethics Team of the University of Birmingham approved on the 22nd November 2010 (ref: ERN_10-0863)
Study design Randomised sham-controlled double blind trial
Countries of recruitment Germany
Disease/condition/study domain Chronic low back pain
Participants - inclusion criteria 1. Aged 18 - 65 years, either sex
2. Categorised as suitable for a pain management programme
3. Have non-specific CLBP (with a minimum of 3 months of low back pain without any relevant ongoing pathologies such as acute disc prolapse, acute inflammation, bone fractures, spondylolisthesis or general health restrictions that require medical attention)
4. Are waiting to attend a cognitive behavioural group programme at a back pain clinic in North Germany
5. Provide written consent
Participants - exclusion criteria 1. Other chronic pain syndromes
2. Spinal surgery in the past 6 month
3. Neurological disease
4. Psychiatric disease
5. Does not understand German
6. Pregnant or likely to become pregnant during the trial
7. Alcohol, drug, or medication abuse
Anticipated start date 20/02/2011
Anticipated end date 30/08/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 135
Interventions 1. Both groups, verum and sham stimulation, will receive 20 minutes of tDCS on 5 consecutive days
2. Sham stimulation consists of a pre-programmed validated sham paradigm, verum stimulation will be with an intensity of 2mA
3. Both groups will be followed-up after they have completed a 4 week group programme as well as 4, 12, 24 weeks after the last day of the programme
Primary outcome measure(s) 1. Pain, measured using the Visual Analogue Scale (VAS) score (0 = no pain, 100 = unbearable pain)
2. Disability, measured using the Oswestry Disability Index
3. Measurements at baseline, after tDCS period, after CBT, at 4 weeks, 12 weeks and 24 weeks post CBT
Secondary outcome measure(s) 1. Subjective Functioning (Funktionsfragebogen Hannover)
2. Fear Avoidance Beliefs Questionnaire
3. Depression (Hospital Anxiety Depression Scale)
4. Quality of Life (SF 36)
5. Bothersomeness (5 point scale)
6. Patient Perceived Satisfactory Improvement (5 point scale)
Measurements at baseline, after tDCS period, after CBT, at 4 weeks, 12 weeks and 24 weeks post CBT.
Sources of funding German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
Trial website
Publications
Contact name Mrs  Kerstin  Luedtke
  Address Martinistr.52
  City/town Hamburg
  Zip/Postcode 20246
  Country Germany
Sponsor University Medical Center Hamburg-Eppendorf (Germany)
  Address c/o Mrs Kerstin Luedtke
Martinistr.52
  City/town Hamburg
  Zip/Postcode 20246
  Country Germany
  Sponsor website: http://www.uke.de/
Date applied 18/01/2011
Last edited 05/05/2011
Date ISRCTN assigned 05/05/2011
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