External peripheral neuromodulation for the relief of chronic pain
| ISRCTN | ISRCTN07743794 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07743794 |
| Protocol serial number | RJ1 09/N084 |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust (UK) |
| Funder | Guy's and St Thomas' NHS Foundation Trust (UK) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Pain Management & Neuromodulation Centre
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre double-blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Visual Analogue Score (VAS) of pain severity one week following third (final) neuromodulation session. |
| Key secondary outcome measure(s) |
1. VAS of pain severity immediately after treatment and at 7 day intervals to end of study (i.e., days 7, 14 and 21) |
| Completion date | 16/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
SE1 7EH
United Kingdom
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/07/2016: No publications found, verifying study status with principal investigator.
