Clinical trial NCT04039633: Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
Official title: Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erythromelalgia
Keywords: Spinal Cord Stimulation
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2019-07-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: During 6 months following implantation of a pulse generator, all patients will undergo 4 six-week long periods with either burst spinal cord stimulation (SCS) or no stimulation (sham) in a randomized order. During this period all patients will undergo two periods of SCS and sham stimulation.
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

1. A diagnosis of primary or idiopathic erythromelalgia
2. Patients ≥18 years who have developed chronic pain that has remained refractory to medical treatment for ≥6 months.
3. Minimum pain intensity of 5/10 on a numeric rating scale NRS at baseline.
4. 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.

Exclusion Criteria:

1. Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy).
2. History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed.
3. Abnormal pain behavior and/or unresolved psychiatric illness.
4. Unresolved issues of secondary gain or inappropriate medication use.
5. Unfit for participation for any other reason as judged by the study physician.

Primary outcomes:
measure: Changes in pain
timeFrame: 6 months
Secondary outcomes:
measure: Change in generic health-related quality of life
timeFrame: 6 months
measure: Oswestry disability index (ODI) score
timeFrame: 6 months
measure: Daily physical activity
timeFrame: 6 months
measure: Severity of erythema
timeFrame: 6 months
measure: Health Care Provider's Costs
timeFrame: 6 months
Other outcomes:
Locations:
city: Halden
country: Norway
facility: Halden Dermatology Center
city: Strømmen
country: Norway
facility: Aleris
city: Tromsø
country: Norway
facility: Universitetssykehuset nord-norge hf
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Sasha Gulati, md prof
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Olavs Hospital
name: Geir Bråthen, md prof
role: STUDY_DIRECTOR
References:
citation: O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.