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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Martinistr.52
Hamburg
20246
Germany
Study information
| Study design | Randomised sham-controlled double-blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 20/02/2011 |
| Completion date | 30/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
20246
Germany
Sponsor information
University Medical Center Hamburg-Eppendorf (Germany)
Hospital/treatment centre
Hospital/treatment centre
c/o Mrs Kerstin Luedtke
Martinistr.52
Hamburg
20246
Germany
| Website | http://www.uke.de/ |
|---|---|
"ROR" |
https://ror.org/01zgy1s35 |
Funders
Funder type
Research council
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
