Condition category
Nervous System Diseases
Date applied
05/08/2009
Date assigned
18/02/2010
Last edited
18/07/2016
Prospective/Retrospective
Retrospectively 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

Dr Teodor Goroszeniuk

ORCID ID

Contact details

Pain Management & Neuromodulation Centre
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

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 measures

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

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

http://www.guysandstthomas.nhs.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/07/2016: No publications found, verifying study status with principal investigator.