NCT04184596

Brief Summary

The objective of this study is to identify and weight attributes of topic and systemic pain treatment options relevant from the patients' perspective with peripheral neuropathic pain. The study will use a discrete choice experimental design to reach its objective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

November 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

February 11, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

November 29, 2019

Last Update Submit

February 17, 2021

Conditions

Keywords

Discrete Choice Experiment

Outcome Measures

Primary Outcomes (1)

  • Patient preferences for topical and systemic pain treatment attributes

    Utility values obtained via multinominal logit estimates from discrete choice experiment

    20 minutes after survey start

Secondary Outcomes (2)

  • Relevance of attributes attributed with topical and systemic pain treatment

    5 minutes after survey start

  • Marginal rate of substitution against pain reduction

    20 minutes after survey start

Study Arms (1)

Stated-Preferences Observational Group

A discrete choice experiment will be conducted with participants with peripheral neuropathic pain in the stated-preferences observational group. The instrument will measure patient preferences for topical versus systemic pain treatment.

Other: Discrete Choice Experiment

Interventions

An online-based Discrete-Choice Experiment (DCE) using a survey for stated treatment preferences and socio-demographics. Furthermore, the neuropathic pain component will be assessed in all patients with the Numeric Pain Rating Scale instrument.

Stated-Preferences Observational Group

Eligibility Criteria

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

A total of 150 patients will be included in this study. Participating centers are outpatient centers, specialist in pain treatment in the state of Hesse.

You may qualify if:

  • Patients with diagnosed peripheral neuropathic pain (pNP) as assessed by study sites

You may not qualify if:

  • Patients with no sufficient knowledge in written or oral German as assessed by study sites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

LinkCare GmbH

Stuttgart, Baden-Wurttemberg, 70469, Germany

Location

Schmerz- und Palliativzentrum Rhein-Main

Wiesbaden, Hesse, 65189, Germany

Location

Schmerzpraxis Wiesbaden

Wiesbaden, Hesse, 65193, Germany

Location

Related Publications (1)

  • Schubert T, Kern KU, Schneider S, Baron R. Oral or Topical Pain Therapy-How Would Patients Decide? A Discrete Choice Experiment in Patients with Peripheral Neuropathic Pain. Pain Pract. 2021 Jun;21(5):536-546. doi: 10.1111/papr.12989. Epub 2021 Feb 1.

    PMID: 33342078BACKGROUND

MeSH Terms

Conditions

NeuralgiaPatient Preference

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPatient SatisfactionTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Tino Schubert, MSc

    LinkCare GmbH

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2019

First Posted

December 3, 2019

Study Start

February 11, 2020

Primary Completion

July 30, 2020

Study Completion

August 31, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations