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Recruiting NCT06546371

Spinal Cord Stimulation for Intractable Mononeuropathy

No phase Interventional Mononeuropathies Spinal Cord Stimulation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spinal cord stimulator.
Who it may be relevant to
Registry conditions: Mononeuropathies, Spinal Cord Stimulation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Spinal Cord Stimulation for Intractable Mononeuropathy: a Pilot Study

Overview

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.

Interventions

  • Device Spinal cord stimulator
    Electrical stimulation of the dorsal horn to reduce chronic pain.

Primary outcome measures

  • Effect of spinal cord stimulation (SCS) in patients with mononeuropathy as assessed by the perceived pain intensity. [Time frame: 6 months]
Secondary outcome measures (3)
  • Effect of SCS in patients with mononeuropathy as assessed by quantitative sensory testing (QST). [Time frame: 6 months]
  • Effect of SCS in patients with mononeuropathy on quality of life. [Time frame: 6 months]
  • Patient preferences for SCS paradigms as assessed by the perceived pain intensity. [Time frame: 3 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Erasmus Medical Centre — Rotterdam

Identifiers

NCT: NCT06546371 · MEC-2023-0644

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗