NCT05190367

Brief Summary

It is well known that patients suffering from chronic pain report higher levels of pain, anxiety, and depression if they have experienced a traumatic event. However, little is know about pain area and widespreadness. In this retrospective study, we want to investigate whether pain area and widespreadness differs in chronic pain patients with and without traumatic events. To test this hypothesis we will retrospectively analyse pain drawings collected at the pain outpatient department from Hannover Medical School. Participants will be divided into four groups depending on the severity of their traumatic events: no trauma; accidental trauma; interpersonal trauma; post-traumatic stress disorder (PTSD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
914

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

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

Study Start

First participant enrolled

February 28, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
Last Updated

January 13, 2022

Status Verified

January 1, 2022

Enrollment Period

1.4 years

First QC Date

December 10, 2021

Last Update Submit

January 12, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Difference in pain area

    Pain area derived from electronic pain drawings (SymptomMapper). The score ranges from 0 to 100% body area.

    First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07

  • Difference in pain widespreadness

    Widespread pain index (WPI) derived from electronic pain drawings (SymptomMapper). The score ranges from 0 (no pain) to 19 (pain affects all possible regions).

    First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07

Secondary Outcomes (10)

  • Difference in current pain

    First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07

  • Difference in mean pain in the last four weeks

    First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07

  • Difference in maximal pain in the last four weeks

    First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07

  • Difference in acceptable pain

    First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07

  • Difference in sleep impairment

    First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07

  • +5 more secondary outcomes

Study Arms (4)

No trauma

Patients suffering from chronic pain without traumatic life events

Accidental trauma

Patients suffering from chronic pain who have experienced at least one accidental trauma

Interpersonal trauma

Patients suffering from chronic pain who have experienced at least one interpersonal trauma

PTSD

Patients suffering from chronic pain and diagnosed with PTSD

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic pain visiting the pain outpatient department at Hannover Medical School.

You may qualify if:

  • Chronic pain

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

Location

Related Publications (1)

  • Manuel J, Rudolph L, Beissner F, Neubert TA, Dusch M, Karst M. Traumatic Events, Posttraumatic Stress Disorder, and Central Sensitization in Chronic Pain Patients of a German University Outpatient Pain Clinic. Psychosom Med. 2023 May 1;85(4):351-357. doi: 10.1097/PSY.0000000000001181. Epub 2023 Feb 21.

MeSH Terms

Conditions

Chronic PainWounds and Injuries

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jorge Manuel Sánchez

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 10, 2021

First Posted

January 13, 2022

Study Start

February 28, 2019

Primary Completion

July 7, 2020

Study Completion

July 7, 2020

Last Updated

January 13, 2022

Record last verified: 2022-01

Locations