External peripheral neuromodulation for the relief of chronic pain
| ISRCTN | ISRCTN07743794 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07743794 |
| Secondary identifying numbers | RJ1 09/N084 |
- Submission date
- 05/08/2009
- Registration date
- 18/02/2010
- Last edited
- 18/07/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Teodor Goroszeniuk
Scientific
Scientific
Pain Management & Neuromodulation Centre
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Study information
| Study design | Single centre double-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| 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 | A randomised controlled feasibility trial of external peripheral neuromodulation in the treatment of intractable localised chronic neuropathic pain |
| Study objectives | The study hypothesis is that, when given over three treatment sessions at weekly intervals, external peripheral neuromodulation will reduce pain severity at 7 days after the final treatment in patients with intractable localised chronic pain with predominantly neuropathic features. |
| Ethics approval(s) | Guy's Research Ethics Committee, 22/04/2009, ref: 09-H0804-46 |
| Health condition(s) or problem(s) studied | Chronic neuropathic pain |
| Intervention | Three 5-minute treatment sessions of external peripheral neuromodulation at 2 Hz (or sham stimulation) at weekly intervals. Follow-up to 7 days after the last session, i.e. 21 days. |
| Intervention type | Other |
| Primary outcome measure | Visual Analogue Score (VAS) of pain severity one week following third (final) neuromodulation session. |
| Secondary outcome measures | 1. VAS of pain severity immediately after treatment and at 7 day intervals to end of study (i.e., days 7, 14 and 21) 2. VAS of pain severity at shorter intervals of less than a week 3. Numerical rating scores (NRS) of: 3.1. Sleep quality 3.2. Functional impact 3.3. Emotional impact Measured at 7 days following third (final) neuromodulation session. 4. Numerical rating scores on Pain Self-Efficacy Questionnaire (PSEQ) at 7 days following third (final) neuromodulation session 5. Changes in medication usage 6. Change in size of painful area on pain/paraesthesiae map |
| Overall study start date | 17/08/2009 |
| Completion date | 16/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Patient age is 18 years or older, either sex 2. Patient has chronic neuropathic (or predominantly neuropathic) intractable pain 3. Patient has an area of pain with a typical dermatomal distribution that can be expected to be covered with a single episode of local stimulation 5. In the opinion of the Investigator and the patient's consultant, all standard medical options have been tried without sufficient improvement in pain control (including opioids, nerve blocks, etc.) 6. Patient has a Visual Analogue Scale (VAS) pain score of 5 cm (or greater) on a 10 cm line |
| Key exclusion criteria | 1. Patient has a history of substance abuse or substance dependency in the past 6 months prior to baseline data collection 2. Patient is currently participating in another clinical study 3. Patient lacks capacity for informed consent to the trial in the view of person taking consent and/or investigators 4. Pregnancy - if the painful area lies within 50 cm of the gravid uterus 5. Patient has difficulties in adequate understanding of English for consent, clinical review and self-completion questionnaires 6. Patient does not permit notification to General Practitioner of enrolment in the study 7. Patient has previous experience of peripheral neuromodulation. Note that prior transcutaneous electrical nerve stimulation (TENS) experience is permitted. |
| Date of first enrolment | 17/08/2009 |
| Date of final enrolment | 16/08/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Pain Management & Neuromodulation Centre
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Guy's and St Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research & Development
3rd Floor Conybeare House
Guy's Hospital
St Thomas Street
London
SE1 9RT
England
United Kingdom
| Website | http://www.guysandstthomas.nhs.uk |
|---|---|
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Government
Guy's and St Thomas' NHS Foundation Trust (UK)
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 |
Editorial Notes
18/07/2016: No publications found, verifying study status with principal investigator.
