Clinical trial NCT06546371: Spinal Cord Stimulation for Intractable Mononeuropathy
Official title: Spinal Cord Stimulation for Intractable Mononeuropathy: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mononeuropathies
Spinal Cord Stimulation
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2024-08-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mono-center explorative pilot study in 12 patients
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* 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)
* Stable or absent concomitant analgesics

Exclusion Criteria:

* Mononeuropathy located in the head or torso
* Mononeuropathy by avulsion at the plexus brachialis
* Life expectancy \<1 year
* Anticoagulant drug therapy or disturbed coagulation
* Immune-compromised patients
* Pregnancy
* Lack of cooperation of the patient or patient has a history of noncompliance with regard to (a) medical regime(s)
* Patients with psychological factors or addiction that require treatment

Primary outcomes:
measure: Effect of spinal cord stimulation (SCS) in patients with mononeuropathy as assessed by the perceived pain intensity.
timeFrame: 6 months
Secondary outcomes:
measure: Effect of SCS in patients with mononeuropathy as assessed by quantitative sensory testing (QST).
timeFrame: 6 months
measure: Effect of SCS in patients with mononeuropathy on quality of life.
timeFrame: 6 months
measure: Patient preferences for SCS paradigms as assessed by the perceived pain intensity.
timeFrame: 3 months
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre
state: Zuid-Holland
Study officials:
References: