Chronic PainNCT05190367
Influence of Trauma on Pain Area and Widespreadness in Chronic Pain Patients
An observational study of Chronic Pain and Trauma, run by Hannover Medical School at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Pain, Trauma
- How many people
- 914 participants
- Where
- 1 siteGermany
- Study dates
- 28 Feb 2019to 7 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic pain visiting the pain outpatient department at Hannover Medical School.
Who may be able to join
- Chronic pain
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Chronic Pain, Trauma
- Medical subject headings
- Chronic Pain, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Difference in pain area
Pain area derived from electronic pain drawings (SymptomMapper). The score ranges from 0 to 100% body area.
Measured: 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).
Measured: 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
Visual analogue scale from 0 ("no pain") to 100 ("maximal imaginable pain").
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start28 Feb 2019
- Primary completion7 Jul 2020
- Study completion7 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 914 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Sanchez, Jorge, Hannover Medical School
- Investigators
- Jorge Manuel Sánchez, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190367
- Sponsor's protocol ID
- 9681
- Status last verified
- Jan 2022
- First submitted
- 10 Dec 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36825929
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Trauma on Pain Area and Widespreadness in Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT05190367
- Acronym / sponsor ID
- 9681
- Conditions
- Chronic Pain, Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 914 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 7 Jul 2020 (actual)
- Study completion
- 7 Jul 2020 (actual)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic pain visiting the pain outpatient department at Hannover Medical School.
Key inclusion criteria (1 listed)
- Chronic pain
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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).
10 secondary outcomes
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Derived from this study: PubMed 36825929Manuel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Manuel Sánchez principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Trauma, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05190367, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.