Clinical Trial: Qutenza (Topical Capsaicin 8%) for Painful Arteriovenous Fistulae

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: The Role of Qutenza (Topical Capsaicin 8%) in Treating Neuropathic Pain From Arteriovenous Fistulae in Patients With End Stage Renal Failure

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.


Detailed Summary:
Sponsor: NHS Greater Glasgow and Clyde

Current Primary Outcome: Neuropathic pain [ Time Frame: 12weeks ]

As assessed by Visual Analogue Pain Score


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Neuropathic pain [ Time Frame: 1 week, 6 weeks ]
    As assessed by Visual Analogue Pain Score and Brief Pain Inventory
  • Quality of life [ Time Frame: 6 weeks, 12 weeks ]
    As assessed by EQ-5D
  • Safety and tolerability [ Time Frame: 1 week, 6 weeks and 12 weeks ]
    As assessed by: Number of adverse reactions.


Original Secondary Outcome:

  • Neuropathic pain [ Time Frame: 1 week, 6 weeks ]
    As assessed by Visual Analogue Pain Score and Brief Pain Inventory
  • Qulaity of life [ Time Frame: 6 weeks, 12 weeks ]
    As assessed by EQ-5D
  • Safety and tolerability [ Time Frame: 1 week, 6 weeks and 12 weeks ]
    Skin will be assessed for breaks/ blisters and tolerability, including the need for rescue analgesia will be recorded


Information By: NHS Greater Glasgow and Clyde

Dates:
Date Received: December 10, 2012
Date Started: November 2015
Date Completion: August 2017
Last Updated: November 9, 2016
Last Verified: November 2016