Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
ConditionErythromelalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Olavs Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy).
History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed.
Abnormal pain behavior and/or unresolved psychiatric illness.
Unresolved issues of secondary gain or inappropriate medication use.
Trial design
Design model
Crossover
Treatments tested in this trial
Burst Spinal Cord Stimulation
Procedure/SurgeryBurst stimulation utilizes complex programming to deliver high-frequency stimuli of a 40 Hz burst mode with 5 spikes at 500 Hz per spike delivered in a constant current mode
Sham spinal cord stimulation
Procedure/SurgeryA pulse generator is implanted, but no spinal cord stimulation is provided
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Burst spinal cord stimulation (SCS)Experimental treatment 2 interventions
Group B: sham spinal cord stimulation (SCS)Sham comparator 2 interventions
Trial outcomes
Primary outcomes
1
Changes in pain
assessed with a 0 -to-10 numerical rating scale (NRS)
Time frame
6 monthsSecondary outcomes
1
Change in generic health-related quality of life
Assessed with the Euro-Qol-5D (5L)
Time frame
6 months2
Oswestry disability index (ODI) score
questionnaire originally designed to quantify disability for degenerative conditions of the lumbar spine, possibly a relevant outcome measure also in patients with erythromelalgia as it covers intensity of pain, ability to care for oneself, ability to walk, ability to sit, ability to lift, sexual function, ability to stand, social life, sleep quality, and ability to travel. The index is scored from 0 to 100. Zero means no disability and 100 reflects maximum disability.
Time frame
6 months3
Daily physical activity
measured by use of a body-worn accelerometer (activPALs from PAL Technologies Ltd., Glasgow, United Kingdom) attached by a waterproof tape to the midpoint of the patients' anterior right thigh
Time frame
6 months4
Severity of erythema
assessed using the Patient's Self-Assessment (PSA) scale
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Olavs Hospital
Lead sponsor
Norwegian University of Science and Technology
Collaborator
Source ClinicalTrials.gov