Spinal Cord Stimulation for Refractory Pain in Erythromelalgia

St. Olavs Hospital24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Erythromelalgia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Halden Dermatology Center

Halden, Norway

RECRUITING

Aleris

Strømmen, Norway

RECRUITING

Universitetssykehuset nord-norge hf

Tromsø, Norway

RECRUITING

St Olavs Hospital

Trondheim, Norway

RECRUITING

Outcomes

Primary Outcomes

Changes in pain

assessed with a 0 -to-10 numerical rating scale (NRS)

Time frame: 6 months

Secondary Outcomes

Change in generic health-related quality of life

Assessed with the Euro-Qol-5D (5L)

Time frame: 6 months

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 months

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 months

Severity of erythema

assessed using the Patient's Self-Assessment (PSA) scale

Time frame: 6 months

Health Care Provider's Costs

Cost-effectiveness (cost per gained quality-adjusted life year)

Time frame: 6 months

Spinal Cord Stimulation for Refractory Pain in Erythromelalgia

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts