Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RJ1 09/N084
Study information
Scientific title
A randomised controlled feasibility trial of external peripheral neuromodulation in the treatment of intractable localised chronic neuropathic pain
Acronym
Study hypothesis
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
Guy's Research Ethics Committee, 22/04/2009, ref: 09-H0804-46
Study design
Single centre double-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
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 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
Phase
Not Applicable
Drug names
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 trial start date
17/08/2009
Overall trial end date
16/08/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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.
Recruitment start date
17/08/2009
Recruitment end date
16/08/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Pain Management & Neuromodulation Centre
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Guy's and St Thomas' NHS Foundation Trust (UK)
Sponsor details
Research & Development
3rd Floor Conybeare House
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Guy's and St Thomas' NHS Foundation Trust (UK)
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
Basic results (scientific)
Publication list