Spinal Cord Stimulation for Intractable Mononeuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-13

Study Completion Date

2025-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Mononeuropathies Spinal Cord Stimulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Mono-center explorative pilot study in 12 patients

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Spinal cord stimulation

Patients are all included in this experimental arm, where they receive all four stimulation options consecutively, but in different orders. After receiving all four stimulation options, the patients are allowed to choose which stimulation option of the four they want to have for the following period.

Group Type EXPERIMENTAL

Spinal cord stimulator

Intervention Type DEVICE

Electrical stimulation of the dorsal horn to reduce chronic pain.

Interventions

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Spinal cord stimulator

Electrical stimulation of the dorsal horn to reduce chronic pain.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No