ErythromelalgiaNCT04039633
Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
A study testing Burst Spinal Cord Stimulation in people with Erythromelalgia, run by St. Olavs Hospital at 4 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erythromelalgia
- What is being tested?
- Burst Spinal Cord Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 4 sitesNorway
- Study dates
- 26 Aug 2019to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
Halden Dermatology Center
Halden
Aleris
Strømmen
Universitetssykehuset nord-norge hf
Tromsø
St Olavs Hospital
Trondheim
About this study
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
- Being tested
- Burst Spinal Cord Stimulation, Sham spinal cord stimulation
- Keywords
- Spinal Cord Stimulation
- Medical subject headings
- Erythromelalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Burst Spinal Cord StimulationProcedure or surgery
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 stimulationProcedure or surgery
A pulse generator is implanted, but no spinal cord stimulation is provided
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Burst Spinal Cord Stimulation; Procedure: Sham spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain
assessed with a 0 -to-10 numerical rating scale (NRS)
Measured: 6 months
Secondary outcomes (5)
Change in generic health-related quality of life
Assessed with the Euro-Qol-5D (5L)
Measured: 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.
Measured: 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
Measured: 6 months
Severity of erythema
assessed using the Patient's Self-Assessment (PSA) scale
Measured: 6 months
Health Care Provider's Costs
Cost-effectiveness (cost per gained quality-adjusted life year)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start26 Aug 2019
- Primary completion23 Apr 2024
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ErythromelalgiaStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Sasha Gulati, md prof, Principal investigator, St. Olavs HospitalGeir Bråthen, md prof, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039633
- Sponsor's protocol ID
- 2019/159
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2019
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34854473
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
- ClinicalTrials.gov ID
- NCT04039633
- Acronym / sponsor ID
- 2019/159
- Conditions
- Erythromelalgia
- Keywords
- Spinal Cord Stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Burst spinal cord stimulation (SCS) | Experimental | Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulationfollowing 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. |
| sham spinal cord stimulation (SCS) | Sham comparator | Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulationfollowing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Burst Spinal Cord StimulationBurst 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 | Procedure or surgery | Burst spinal cord stimulation (SCS), sham spinal cord stimulation (SCS) |
| Sham spinal cord stimulationA pulse generator is implanted, but no spinal cord stimulation is provided | Procedure or surgery | Burst spinal cord stimulation (SCS), sham spinal cord stimulation (SCS) |
Primary outcome
Changes in pain
Time frame: 6 months
assessed with a 0 -to-10 numerical rating scale (NRS)
5 secondary outcomes
Change in generic health-related quality of life
Time frame: 6 months
Oswestry disability index (ODI) score
Time frame: 6 months
Daily physical activity
Time frame: 6 months
Severity of erythema
Time frame: 6 months
Health Care Provider's Costs
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Derived from this study: PubMed 34854473O'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.
- Individual participant dataSharing planned: No
Related trials for Erythromelalgia
Active, not recruitingPhase 1
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
Familial Erythromelalgia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sasha Gulati, md prof principal investigator
St. Olavs Hospital
Geir Bråthen, md prof study director
St. Olavs Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Burst Spinal Cord Stimulation in people with Erythromelalgia, run by St. Olavs Hospital at 4 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04039633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.