NCT05482152

Brief Summary

Chronic pain is a multidimensional problem that consequently requires interventions on multiple levels. Pain education by physicians is one of the interventions that shows promising results in patient reported outcomes. It is however unclear if nurse-led chronic pain education could be equally effective on pain attitude and behavior in chronic pain patients. The aim of this clinical trial is to investigate the effects of a nurse-led consultation with chronic pain patients on pain attitude and patient satisfaction compared with regular care without nurse specialist intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

January 13, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

January 14, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

May 20, 2024

Status Verified

May 1, 2024

Enrollment Period

12 months

First QC Date

January 13, 2022

Last Update Submit

May 17, 2024

Conditions

Pain, Chronic

Outcome Measures

Primary Outcomes (1)

  • Patient attitude on chronic pain

    Pain Solutions Questionnaire (PaSol)

    Up to 10 months

Secondary Outcomes (1)

  • Patient satisfaction

    Up to 10 months

Study Arms (2)

Standard physician led care

NO INTERVENTION

Consultation by physician (pain specialist)

Nurse-led care

EXPERIMENTAL

Preclinical nurse-led consultation and standard care by physician (pain specialist)

Behavioral: Nurse-led care by a nurse specialist in pain

Interventions

Nurse-led care by a nurse specialist in painBEHAVIORAL

A nurse pain specialist consultation in patients in the experimental arm before they receive standard care by a physician.

Nurse-led care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • dutch speaking
  • first time consultation

You may not qualify if:

  • Palliative care patients
  • Patients with dementia diagnosis
  • Urgent referral to the pain clinic by other physicians

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZLeuven

Leuven, Belgium

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bart Morlion, MD PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2022

First Posted

August 1, 2022

Study Start

January 14, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2023

Last Updated

May 20, 2024

Record last verified: 2024-05

Locations

BE(1)