Spinal Cord Stimulation for Refractory Pain in Erythromelalgia

Erythromelalgia Clinical Trial

Official title:

Spinal Cord Stimulation for Refractory Pain in Erythromelalgia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04039633
• Other study ID #: 2019/159
• Status: Recruiting
• Phase: N/A
• Start date: August 26, 2019
• Est. completion date: January 2025

Study information

• Verified date: April 2023
• Source: St. Olavs Hospital
• Contact: Sasha Gulati, md prof
• Phone: +47 73592020
• Email: sasha.gulati[@]ntnu.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erythromelalgia
• Pain, Intractable

Intervention

Procedure:
• Burst Spinal Cord Stimulation
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
A pulse generator is implanted, but no spinal cord stimulation is provided

Locations

Country	Name	City	State
Norway	Halden Dermatology Center	Halden
Norway	Aleris	Strømmen
Norway	Universitetssykehuset nord-norge hf	Tromsø
Norway	St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in pain	assessed with a 0 -to-10 numerical rating scale (NRS)	6 months
Secondary	Change in generic health-related quality of life	Assessed with the Euro-Qol-5D (5L)	6 months
Secondary	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.	6 months
Secondary	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	6 months
Secondary	Severity of erythema	assessed using the Patient's Self-Assessment (PSA) scale	6 months
Secondary	Health Care Provider's Costs	Cost-effectiveness (cost per gained quality-adjusted life year)	6 months