Spinal Cord Stimulation for Refractory Pain in Erythromelalgia

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Erythromelalgia is a rare disorder characterized by red, warm, and painful extremities, which is often precipitated by warm conditions. The pathophysiology is incompletely understood. The management of pain in erythromelalgia is challenging as no single therapy has been found to be effective. Response to pharmacotherapy varies, meaning that the physician has to take a stepwise trial and error approach with each patient. Consequently, this disorder is often associated with poorer health-related quality of life. There is currently no consensus or guideline on management of pain in erythromelalgia. Spinal cord stimulation is a widely applied therapy to treat severe chronic pain of various origin. Case reports and anecdotal evidence suggest that this therapy might alleviate refractory pain in patients with erythromelalgia. The aim of this trial is to evaluate the efficacy of spinal cord stimulation for refractory pain in erythromelalgia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• A diagnosis of primary or idiopathic erythromelalgia

• Patients ≥18 years who have developed chronic pain that has remained refractory to medical treatment for ≥6 months.

• Minimum pain intensity of 5/10 on a numeric rating scale NRS at baseline.

• Successful two-week SCS testing period with tonic stimulation (≥2 points reduction in pain NRS from baseline). This means patients will experience paresthesia during the trial period of spinal cord stimulation.

Locations
Other Locations
Norway
Halden Dermatology Center
RECRUITING
Halden
Aleris
RECRUITING
Strømmen
Universitetssykehuset nord-norge hf
RECRUITING
Tromsø
St Olavs Hospital
RECRUITING
Trondheim
Contact Information
Primary
Sasha Gulati, md prof
sasha.gulati@ntnu.no
+47 73592020
Backup
Sven M Carlsen, md prof
sven.carlsen@ntnu.no
+47 91769528
Time Frame
Start Date: 2019-08-26
Estimated Completion Date: 2026-01
Participants
Target number of participants: 24
Treatments
Experimental: Burst spinal cord stimulation (SCS)
following implantation of a generator that sends pulses to a thin wire (lead), which delivers pulses to nerves along the spinal cord, the patients will initially undergo four six-week long periods with either burst SCS or no stimulation (sham) in a randomized order. During this period all patients will undergo two periods of SCS and sham stimulation.
Sham_comparator: sham spinal cord stimulation (SCS)
following implantation of a generator that sends pulses to a thin wire (lead), which delivers pulses to nerves along the spinal cord, the patients will initially undergo four six-week long periods with either burst SCS or no stimulation (sham) in a randomized order. During this period all patients will undergo two periods of SCS and sham stimulation.
Related Therapeutic Areas
Sponsors
Leads: St. Olavs Hospital
Collaborators: Norwegian University of Science and Technology

This content was sourced from clinicaltrials.gov

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