Spinal Cord Stimulation for Refractory Pain in Erythromelalgia

NCT04039633 | Recruiting

• 1 other identifier: 2019/159
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 4

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.

Conditions

Erythromelalgia

Keywords

Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (1)

• Changes in pain

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

  6 months

Secondary Outcomes (5)

• Change in generic health-related quality of life

  6 months

• Oswestry disability index (ODI) score

  6 months

• Daily physical activity

  6 months

• Severity of erythema

  6 months

• Health Care Provider's Costs

  6 months

Study Arms (2)

Burst spinal cord stimulation (SCS)

EXPERIMENTAL

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.

Procedure: Burst Spinal Cord Stimulation; Procedure: Sham spinal cord stimulation

sham spinal cord stimulation (SCS)

SHAM COMPARATOR

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.

Procedure: Burst Spinal Cord Stimulation; Procedure: Sham spinal cord stimulation

Interventions

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

Burst spinal cord stimulation (SCS); sham spinal cord stimulation (SCS)

Sham spinal cord stimulation PROCEDURE

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

Burst spinal cord stimulation (SCS); sham spinal cord stimulation (SCS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (4)

Halden Dermatology Center

Halden, Norway

RECRUITING

Aleris

Strømmen, Norway

RECRUITING

Universitetssykehuset nord-norge hf

Tromsø, Norway

RECRUITING

St Olavs Hospital

Trondheim, Norway

RECRUITING

Related Publications (1)

• 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.

  PMID: 34854473 DERIVED

MeSH Terms

Conditions

Erythromelalgia

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sasha Gulati, md prof

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

• Geir Bråthen, md prof

  St. Olavs Hospital

  STUDY DIRECTOR

Central Study Contacts

Sasha Gulati, md prof

CONTACT

+47 73592020; sasha.gulati@ntnu.no

Sven M Carlsen, md prof

CONTACT

+47 91769528; sven.carlsen@ntnu.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 1st blinding: patients will be blinded to the actual treatment allocation during the different study periods (first blinding). 2nd: surgeons and all study personnel involved in handling the patients and collecting the study data (except those who perform the actual setting of the device) will be blinded to the actual treatment allocation. 3rd: All study personnel evaluating end point measures will be blinded to the actual treatment. 4th All the tables and figures to be presented from the study will be settled before any data from the study is evaluated in order to avoid selective presentation of findings according to statistical results. 5th The statistician performing the statistical procedures on the outcome of the study will be blinded. The data will only show treatment allocation as treatment A and treatment B. Then the tables and figures are filled in.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: July 31, 2019
• Study Start: August 26, 2019
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (4)