Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effectiveness of anodal transcranial direct current stimulation (tDCS) in patients with chronic low back pain: a randomised controlled trial
Acronym
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
Ethics approval
1. Germany: Ethik-Kommission der Aerztekammer Hamburg approved on 04/01/2010, ref: PV3297. An amendment was approved on the 07/07/2010.
2. UK: Research Ethics Team of the University of Birmingham approved on 22/11/2010, ref: ERN_10-0863
Study design
Randomised sham-controlled double-blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic low back pain
Intervention
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
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
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 measures
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.
Overall trial start date
20/02/2011
Overall trial end date
30/08/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
135
Participant 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
Recruitment start date
15/05/2011
Recruitment end date
30/03/2013
Locations
Countries of recruitment
Germany
Trial participating centre
Martinistr.52
Hamburg
20246
Germany
Sponsor information
Organisation
University Medical Center Hamburg-Eppendorf (Germany)
Sponsor details
c/o Mrs Kerstin Luedtke
Martinistr.52
Hamburg
20246
Germany
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research council
Funder name
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25883244