Condition category
Musculoskeletal Diseases
Date applied
18/01/2011
Date assigned
05/05/2011
Last edited
02/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Kerstin Luedtke

ORCID ID

Contact details

Martinistr.52
Hamburg
20246
Germany

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

http://www.uke.de/

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

Publication citations

Additional files

Editorial Notes