Influence of Trauma on Pain Area and Widespreadness in Chronic Pain Patients

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).

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Trauma

• Study Type: Observational
• Enrollment (Actual): 914

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany, 30625
    • Hannover Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Chronic pain

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in current pain	Visual analogue scale from 0 ("no pain") to 100 ("maximal imaginable 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	Visual analogue scale from 0 ("no pain") to 100 ("maximal imaginable 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 maximal pain in the last four weeks	Visual analogue scale from 0 ("no pain") to 100 ("maximal imaginable 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 acceptable pain	Visual analogue scale from 0 ("no pain") to 100 ("maximal imaginable 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	Visual analogue scale from 0 ("no impairment") to 100 ("maximal imaginable impairment").	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-related disability	Pain-related disability assessed via the Pain Disability Index (PDI). The score ranges from 0 (no pain-related disability) to 70 (maximal disability).	First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
Difference in depression	Depression assessed via the 9-item depression scale (PHQ-9) from the German version of the Patient Health Questionnaire (PHQ-D). The score ranges from 0 (no depression) to 27 (maximal depression).	First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
Difference in somatic symptoms	Somatic symptoms assessed via the 15-item somatic scale (PHQ-15) from the German version of the Patient Health Questionnaire (PHQ-D). The score ranges from 0 (no somatic symptom burden) to 30 (maximal somatic symptom burden).	First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
Difference in anxiety	Anxiety assessed via the 7-item anxiety scale (GAD-7) from the German version of the Patient Health Questionnaire (PHQ-D). The score ranges from 0 (no anxiety) to 21 (maximal anxiety).	First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
Difference in stress	Stress assessed via the 10-item stress scale (PHQ-Stress) from the German version of the Patient Health Questionnaire (PHQ-D). The score ranges from 0 (no stress) to 20 (maximal stress).	First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: Jorge Manuel Sánchez, Hannover Medical School

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2019
• Primary Completion (Actual): July 7, 2020
• Study Completion (Actual): July 7, 2020

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Wounds and Injuries
• Other Study ID Numbers: 9681 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No