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NCT Number: NCT04039633

Spinal Cord Stimulation for Refractory Pain in Erythromelalgia

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.

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Key information

Conditions

Erythromelalgia Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Halden Dermatology Center, Halden, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Unfit for participation for any other reason as judged by the study physician.

Treatment and study plan

Burst Spinal Cord Stimulation

Procedure

Burst 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

A pulse generator is implanted, but no spinal cord stimulation is provided

Primary outcomes

  1. Changes in pain

    Time frame: 6 months

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

Secondary outcomes

  1. Change in generic health-related quality of life

    Time frame: 6 months

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

  2. Oswestry disability index (ODI) score

    Time frame: 6 months

    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.

  3. Daily physical activity

    Time frame: 6 months

    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

  4. Severity of erythema

    Time frame: 6 months

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

  5. Health Care Provider's Costs

    Time frame: 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sasha Gulati, md prof

CONTACT

[email protected]

+47 73592020

Sven M Carlsen, md prof

CONTACT

[email protected]

+47 91769528

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2019
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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