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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05190367

Enrollment

914

Registered

2022-01-13

Start date

2019-02-28

Completion date

2020-07-07

Last updated

2022-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Trauma

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).

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Chronic pain

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
Difference in pain area	First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07	Pain area derived from electronic pain drawings (SymptomMapper). The score ranges from 0 to 100% body area.
Difference in pain widespreadness	First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07	Widespread pain index (WPI) derived from electronic pain drawings (SymptomMapper). The score ranges from 0 (no pain) to 19 (pain affects all possible regions).

Secondary

Measure	Time frame	Description
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	Visual analogue scale from 0 (no pain) to 100 (maximal imaginable pain).
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	Visual analogue scale from 0 (no pain) to 100 (maximal imaginable pain).
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	Visual analogue scale from 0 (no impairment) to 100 (maximal imaginable impairment).
Difference in pain-related disability	First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07	Pain-related disability assessed via the Pain Disability Index (PDI). The score ranges from 0 (no pain-related disability) to 70 (maximal disability).
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	Visual analogue scale from 0 (no pain) to 100 (maximal imaginable pain).
Difference in somatic symptoms	First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07	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).
Difference in anxiety	First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07	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).
Difference in stress	First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07	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).
Difference in depression	First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07	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).
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	Visual analogue scale from 0 (no pain) to 100 (maximal imaginable pain).

Countries

Germany

Outcome results