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	https://doi.org/10.1186/ISRCTN89874874
Protocol serial number	N/A
Sponsor	University Medical Center Hamburg-Eppendorf (Germany)
Funder	German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)

Submission date: 18/01/2011
Registration date: 05/05/2011
Last edited: 02/06/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Kerstin Luedtke
Scientific

Martinistr.52
Hamburg
20246
Germany

Study information

Primary study design	Interventional
Study design	Randomised sham-controlled double-blind trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effectiveness of anodal transcranial direct current stimulation (tDCS) in patients with chronic low back pain: a randomised controlled trial
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
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
Key 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.
Completion date	30/08/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	135
Key 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
Key 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
Date of first enrolment	15/05/2011
Date of final enrolment	30/03/2013

Locations

Countries of recruitment

Germany

Study participating centre

Martinistr.52

Hamburg
20246
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	16/04/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes