External peripheral neuromodulation for the relief of chronic pai

Not Applicable

Completed

Conditions: Chronic neuropathic pain
Nervous System Diseases
Disorders of autonomic nervous system

Registration Number: ISRCTN07743794

Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Analogue Score (VAS) of pain severity one week following third (final) neuromodulation session.

Secondary Outcome Measures

Name	Time	Method
1. VAS of pain severity immediately after treatment and at 7 day intervals to end of study (i.e., days 7, 14 and 21)<br>2. VAS of pain severity at shorter intervals of less than a week<br>3. Numerical rating scores (NRS) of:<br>3.1. Sleep quality<br>3.2. Functional impact<br>3.3. Emotional impact <br>Measured at 7 days following third (final) neuromodulation session.<br>4. Numerical rating scores on Pain Self-Efficacy Questionnaire (PSEQ) at 7 days following third (final) neuromodulation session<br>5. Changes in medication usage<br>6. Change in size of painful area on pain/paraesthesiae map