External peripheral nerve stimulation for the treatment of neuropathic pain following nerve injury

Not Applicable

Completed

• Conditions: europathic pain following peripheral nerve injury; Nervous System Diseases; Neuropathic pain following peripheral nerve injury

• Registration Number: ISRCTN53432663
• Lead Sponsor: The Walton Centre NHS Trust

Brief Summary

2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/27919285 protocol 2021 Results article in https://doi.org/10.1186/s12967-021-03128-2 (added 09/11/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-07
• Study Completion: 2020-01-16
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1. Chronic neuropathic pain following peripheral nerve injury, definite or probable:
1.1. Pain with a distinct neuroanatomically plausible distribution
1.2. A history suggestive of a relevant lesion or disease affecting the peripheral or central somatosensory system
1.3. Demonstration of the distinct neuroanatomically plausible distribution by at least one confirmatory test
1.4. Demonstration of the relevant lesion or disease by at least one confirmatory test
Grading of certainty for the presence of neuropathic pain: definite neuropathic pain: all (1 to 4); probable neuropathic pain: 1 and 2, plus either 3 or 4 (Treede, Jensen et al. 2008)
2. At least 12 months duration of neuropathic pain symptoms
3. Adults age 18 years or above
4. Moderate to severe pain intensity (Average 24 hour pain intensity over 7-days at baseline of = 5/10 but not dropping below 4 on any single day, on an 11-point (0-10) numerical rating scale (NRS))
5. Pain localised to the distribution of 1-2 peripheral nerves
6. Distribution of pain that will allow for the nerve to be stimulated proximally from the areas of pain.
7. Discontinuation of numbing pain medications (lidocaine patches 4 weeks prior, Capsaicin 4 months prior)
8. Patients should have trialed first line pharmacotherapy (First-line treatment include either tricyclic antidepressants or serotonin-noradrenaline reuptake inhibitors, pregabalin or gabapentin)
9. Moderate- severe brush stroke allodynia (Defined as pain of = 5/10 on an 11-point (0-10) numerical rating scale (NRS), when brush stroke is applied to the affected area (average of 3 strokes over affected area))
10. Willing to not commence any new medications/ treatments for their neuropathic pain whilst involved in the trial
11. Women of childbearing potential may participate providing they are using adequate birth control methods for the duration of the trial (including accepted methods of contraception such as; barrier methods, intrauterine device IUD, contraceptive implant, depot injection, oral contraception and abstinence (as part of lifestyle choice))

Exclusion Criteria

1. Absolute numbness within area of pain (suggests sufficient nerve damage to render EN-PNS unlikely to work)
2. Known EN-PNS contraindications (pregnancy and cardiac pacemakers)*
3. Other chronic pains or unstable medical conditions, which in the opinion of the investigator would make the trial unsuitable for the patient
4. Unstable pain intensity or pain medications 6 weeks prior to the study that in the judgement of the PI would interfere with assessment of outcome
5. Persons participating in an interventional trial within the past 3 months
6. Persons participating in a non-interventional trials completed within 2 weeks prior to start of the trial
7. Diagnosed psychiatric or mental health disorder which in the judgment of the PI interferes with successful study participation
8. Inability to comply with the study protocol for the trial-period of 3 months
9. Inability to complete outcome measures
10. Incapacity to understand the information necessary to provide informed consent
11. Other implanted device for the same pain complaints such as spinal cord stimulation (SCS)
12. Phantom Limb pain**

*Non pregnancy confirmed by urine test at baseline and at treatment end
**Stump pain can be treated

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average 24 hour pain intensity recorded on an 11-point (0-10) numerical rating scale, averaged over the last 7 days of the 3 month home-loan period.