Spinal Cord Stimulation for Intractable Mononeuropathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasmus Medical Center
About this trial
Rationale: For patients with mononeuropathy, literature has shown that spinal cord stimulation (SCS) is an effective therapy for patients who are therapy-resistant to more conventional treatments. However, there is a strong need for higher quality evidence to determine the place of this therapy in this target group. Before conducting a large randomized controlled trial (RCT) we propose to conduct an explorative pilot study based on which an effect size estimation and power calculation for a larger study can be done. We will assess the effects of SCS in patients with mononeuropathy measured according to the "Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials" (IMMPACT) guidelines, and assess the stimulation paradigm preferences in these patients.
Objective: To perform an explorative pilot study based on which an effect size estimation and power calculation for an efficacy trial can be done.
Study design: Mono-center explorative pilot study in 12 patients with intractable peripheral mononeuropathic pain who receive a spinal cord stimulator at the Erasmus Medical Centre.
Study population: 12 patients suffering from intractable peripheral mononeuropathic pain.
Intervention: Participants who receive a spinal cord stimulator must fill in IMMPACT guideline questionnaires and undergo several measurement procedures after receiving SCS implantation. The effect of various SCS paradigms on the chronic mononeuropathic pain is assessed at 3 and 6 months.
Main study parameters/endpoints: Effect of 6 months of individually optimized SCS in patients with mononeuropathy according to the IMMPACT guidelines.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Suffering from painful intractable peripheral mononeuropathy in the distal extremities, preferably post-traumatic or post-surgical, confirmed by electromyography (EMG)
Symptoms refractory to conventional medical management for at least 6 months according to treating physician
18 years or older
Pain score on numeric rating scale (NRS) of at least 5 (average pain intensity in week prior to assessment)
Disqualifiers
Mononeuropathy located in the head or torso
Mononeuropathy by avulsion at the plexus brachialis
Life expectancy <1 year
Anticoagulant drug therapy or disturbed coagulation
Trial design
Design model
Single group
Treatments tested in this trial
Spinal cord stimulator
DeviceElectrical stimulation of the dorsal horn to reduce chronic pain.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Spinal cord stimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Effect of spinal cord stimulation (SCS) in patients with mononeuropathy as assessed by the perceived pain intensity.
Perceived pain intensity as assessed by the brief pain inventory (BPI), with pain scores where 0 is no pain and 10 is worst pain imaginable.
Time frame
6 monthsSecondary outcomes
1
Effect of SCS in patients with mononeuropathy as assessed by quantitative sensory testing (QST).
Quantitative sensory testing (QST) measures sensory thresholds for pain, touch, vibration, and temperature sensations, with the main goal to assess sensory functioning.
Time frame
6 months2
Effect of SCS in patients with mononeuropathy on quality of life.
Quality of life as assessed by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire.
Time frame
6 months3
Patient preferences for SCS paradigms as assessed by the perceived pain intensity.
Perceived pain intensity as assessed by the brief pain inventory (BPI), with pain scores where 0 is no pain and 10 is worst pain imaginable.
Time frame
3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Erasmus Medical Center
Lead sponsor
Boston Scientific Corporation
Collaborator
Source ClinicalTrials.gov