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NCT Number: NCT05190367

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).

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Hannover Medical School

Hanover, 30625, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic pain

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Difference in pain area

    Time frame: 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.

  2. Difference in pain widespreadness

    Time frame: 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 outcomes

  1. Difference in current pain

    Time frame: 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").

  2. Difference in mean pain in the last four weeks

    Time frame: 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").

  3. Difference in maximal pain in the last four weeks

    Time frame: 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").

  4. Difference in acceptable pain

    Time frame: 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").

  5. Difference in sleep impairment

    Time frame: 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").

  6. Difference in pain-related disability

    Time frame: 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).

  7. Difference in depression

    Time frame: 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).

  8. Difference in somatic symptoms

    Time frame: 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).

  9. Difference in anxiety

    Time frame: 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).

  10. Difference in stress

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 13, 2022
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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