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Spinal Cord Stimulation for Refractory Pain in Erythromelalgia

Primary Purpose

Erythromelalgia

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Burst Spinal Cord Stimulation
Sham spinal cord stimulation
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erythromelalgia focused on measuring Spinal Cord Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Halden Dermatology CenterRecruiting
  • AlerisRecruiting
  • Universitetssykehuset nord-norge hfRecruiting
  • St Olavs HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Burst spinal cord stimulation (SCS)

sham spinal cord stimulation (SCS)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in generic health-related quality of life
Assessed with the Euro-Qol-5D (5L)
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.
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
Severity of erythema
assessed using the Patient's Self-Assessment (PSA) scale
Health Care Provider's Costs
Cost-effectiveness (cost per gained quality-adjusted life year)

Full Information

First Posted
July 30, 2019
Last Updated
April 14, 2023
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04039633
Brief Title
Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
Official Title
Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2019 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythromelalgia
Keywords
Spinal Cord Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Burst spinal cord stimulation (SCS)
Arm Type
Experimental
Arm Description
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.
Arm Title
sham spinal cord stimulation (SCS)
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Burst Spinal Cord Stimulation
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Sham spinal cord stimulation
Intervention Description
A pulse generator is implanted, but no spinal cord stimulation is provided
Primary Outcome Measure Information:
Title
Changes in pain
Description
assessed with a 0 -to-10 numerical rating scale (NRS)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in generic health-related quality of life
Description
Assessed with the Euro-Qol-5D (5L)
Time Frame
6 months
Title
Oswestry disability index (ODI) score
Description
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
Title
Daily physical activity
Description
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
Title
Severity of erythema
Description
assessed using the Patient's Self-Assessment (PSA) scale
Time Frame
6 months
Title
Health Care Provider's Costs
Description
Cost-effectiveness (cost per gained quality-adjusted life year)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sasha Gulati, md prof
Phone
+47 73592020
Email
sasha.gulati@ntnu.no
First Name & Middle Initial & Last Name or Official Title & Degree
Sven M Carlsen, md prof
Phone
+47 91769528
Email
sven.carlsen@ntnu.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sasha Gulati, md prof
Organizational Affiliation
St. Olavs Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Geir Bråthen, md prof
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Halden Dermatology Center
City
Halden
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandros L Stefou, md
Facility Name
Aleris
City
Strømmen
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mari S Kvernebo, md
Facility Name
Universitetssykehuset nord-norge hf
City
Tromsø
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Øystein Grimstad, md phd
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sasha Gulati, md phd
First Name & Middle Initial & Last Name & Degree
Sozaburo Hara, md
First Name & Middle Initial & Last Name & Degree
Agnete M Gulati, md
First Name & Middle Initial & Last Name & Degree
Jan Jørgensen, md

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34854473
Citation
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.
Results Reference
derived

Learn more about this trial

Spinal Cord Stimulation for Refractory Pain in Erythromelalgia

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