NCT03037684

Brief Summary

The aim of the study is to evaluate voltage gated sodium channel (NaV1.7) dependent pain phenomena in neuropathic pain and chronic postoperative pain.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 27, 2017

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

8.8 years

First QC Date

January 16, 2017

Last Update Submit

December 1, 2025

Conditions

Keywords

neuropathic painchronic postoperative pain

Outcome Measures

Primary Outcomes (1)

  • change in pain intensity

    numeric rating scale (NRS), rating from 0-10, 0=no pain, 10=maximum pain imaginable

    at baseline and during electric nerve stimulation

Secondary Outcomes (16)

  • heat pain threshold

    baseline

  • cold pain threshold

    baseline

  • mechanical detection threshold

    baseline

  • mechanical pain threshold

    baseline

  • mechanical pain sensitivity

    baseline

  • +11 more secondary outcomes

Study Arms (2)

chronic pain

individuals suffering from chronic pain

Diagnostic Test: neurophysiology

neuropathic pain

individuals suffering from neuropathic pain

Diagnostic Test: neurophysiology

Interventions

neurophysiologyDIAGNOSTIC_TEST

electrophysiologic measurements of peripheral nerves

chronic painneuropathic pain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with neuropathic pain or with chronic postoperative pain

You may qualify if:

  • Group (1) patients with neuropathic pain
  • Group (2) patients with chronic postoperative pain

You may not qualify if:

  • severe psychiatric disorder requiring hospitalisation in the past
  • any neurological disease other than the pain diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Pain Medicine

Nottwil, 6207, Switzerland

RECRUITING

Related Publications (1)

  • Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11.

    PMID: 16697110BACKGROUND

MeSH Terms

Conditions

NeuritisNeuralgiaPain, Postoperative

Interventions

Postsynaptic Potential Summation

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

Synaptic TransmissionSignal TransductionBiochemical PhenomenaChemical PhenomenaSynaptic PotentialsMembrane PotentialsCell Physiological PhenomenaElectrophysiological PhenomenaPhysiological PhenomenaNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Gunther Landmann, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2017

First Posted

January 31, 2017

Study Start

March 27, 2017

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

December 8, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations