Clinical trial NCT01748422: Qutenza (Topical Capsaicin 8%) for Painful Arteriovenous Fistulae
Official title: The Role of Qutenza (Topical Capsaicin 8%) in Treating Neuropathic Pain From Arteriovenous Fistulae in Patients With End Stage Renal Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuropathic Pain
Arteriovenous Fistulae
Keywords: Neuropathic pain
Arteriovenous fistulae
End stage renal disease
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with end stage renal failure and chronic neuroapthic pain arising fromt heir arteriovenous fistulae

Brief summary: Arteriovenous fistulae are artificial connections between the artery and vein in the arm which allow needles to be inserted for haemodialysising patients wit kidney failure. Occasionally severe debilitating pain can arise from these fistulae for which no cause can be found. Such pain can be very difficult to treat. Many commonly used used painkillers are known to cause significant side effects in patients with renal failure (drowsiness, confusion etc.

Qutenza (topical capsaicin 8%) is a new treatment made from chilli peppers which is applied to the skin as a patch and works directly at the nerve endings in the skin to prevent pain. It therefore should not have the systemic side effects of other drugs. It has been demonstrated to be beneficial in other painful conditions for example post-shingles pain and nerve pain from HIV. It has never been used for critical ischaemia before.

We propose to investigate the efficacy of Qutenza in treating patients with end stage renal failure and chronic pain from their fistulae (AVF). We will recruit 20 patients with painful AVF and treat them with Qutenza. We will follow them up for 12 weeks and monitor the change in their pain scores.


Eligibility criteria: Inclusion Criteria:

* All adult patients \>18 years old with end stage renal disease on dialysis and significant chronic neuropathic pain arising from their arteriovenous fistula (defined as pain with symptoms to suggest a neuropathic element occurring most days for at least a month which has not responded to simple analgesia)

Exclusion Criteria:

* Pre-dialysis
* Underlying anatomical/ structural abnormality with AVF contributing to pain
* Diabetic neuropathy resulting in sensory loss
* Hypersensitivity to Qutenza, Emla or any of the excipients
* Broken skin or active ulceration at the site of application
* Severe uncontrolled hypertension (systolic BP \>200)
* Proven cardiac event during the preceding 3 months
* Women who are pregnant or breast feeding
* Lack of capacity or inability to provide informed consent
* Declines participation in the study

Primary outcomes:
measure: Neuropathic pain
timeFrame: 12weeks
Secondary outcomes:
measure: Neuropathic pain
timeFrame: 1 week, 6 weeks
measure: Quality of life
timeFrame: 6 weeks, 12 weeks
measure: Safety and tolerability
timeFrame: 1 week, 6 weeks and 12 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Department of Renal Surgery, Queen Elizabeth University Hospital
state: Lanarkshire
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: Patrick K Kearns, MBChB
role: PRINCIPAL_INVESTIGATOR
affiliation: NHS Greater Glasgow and Clyde
name: Marc Clancy, FRCS, PhD
role: PRINCIPAL_INVESTIGATOR
References: