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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05190367
• Other study ID #: 9681
• Status: Completed
• Start date: February 28, 2019
• Est. completion date: July 7, 2020

Study information

• Verified date: January 2022
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 914
• Est. completion date: July 7, 2020
• Est. primary completion date: July 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Chronic pain

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Chronic Pain
• Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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