Chronic PainNCT04473014
The Role of Sensory Processing Sensitivity in Pediatric Chronic Pain
An observational study of Chronic Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim of this project is to increase scientific understanding of whether the trait of SPS can help explain increased pain sensitivity and hence vulnerability for chronic pain. Additionally, it will be tested whether participants with high SPS report differences in pain intensity in response to positive, negative, or… Read more about this study
- Who is it for?
- Ages 16 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Heat Pain Paradigm
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Jun 2021to 15 May 2022
- 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 16 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants will be recruited from local schools and at the University of Basel, Switzerland.
Who may be able to join
- Healthy adolescents aged 16-19 years
Who cannot join
- Chronic pain or another chronic condition
- Skin pathologies
- Sensory abnormalities affecting the tactile or thermal modality
- Pregnancy
- Current medication
- Current psychological or psychiatric treatment
- Insufficient language skills to understand the instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Towards a Deeper Understanding of Chronic Pediatric Pain: Exploring the Role of Sensory Processing Sensitivity
The aim of this project is to increase scientific understanding of whether the trait of SPS can help explain increased pain sensitivity and hence vulnerability for chronic pain. Additionally, it will be tested whether participants with high SPS report differences in pain intensity in response to positive, negative, or neutral mood induction compared to individuals with lower SPS.
Read the detailed description
Background: Pain is defined as an unpleasant sensory and emotional experience and in its chronic form, pain is highly prevalent, up to 25% of children and adolescents are affected by it. The exact etiology of many forms of chronic pain remains unknown. One mechanism that has been proposed to underlie increased pain sensitivity is central sensitization, i.e., increased efficacy of the nervous system in transmitting pain signals, which manifests itself as a lower pain threshold. A lower pain threshold in turn has been recognized as a risk factor for the development of chronic pain. Being more sensitive to pain is one feature commonly shared by those with high sensory processing sensitivity (SPS), who are thought to react more strongly to both positive and negative environmental influences. The relationship between this increased sensitivity and pain tolerance has not been studied to date, but could contribute to our understanding of why some children and adolescents are more vulnerable to developing chronic pain than others.
Objectives and Aims: The aim of this project is to increase scientific understanding of whether the trait of SPS can help explain increased pain sensitivity and hence vulnerability for chronic pain. Additionally, it will be tested whether participants with high SPS report differences in pain intensity in response to positive, negative, or neutral mood induction compared to individuals with lower SPS.
Methods: To examine differences in pain perception of an experimentally induced pain stimulus between people with varying levels of SPS and whether pain perception can modulated by positive, negative, or neutral mood induction, I will apply a heat pain paradigm in a sample of healthy adolescents. Participants will be randomized to either neutral, positive or negative mood induction and I will test whether their pain sensitivity differs as a function of their scores on a high sensitivity scale and with regard to mood induction.
Expected Results: We expect highly sensitive adolescents to have a lower pain threshold and tolerance and to react more strongly to positive (with decreased pain ratings) and negative (with increased pain ratings) mood induction compared to those with lower scores on the sensitivity scale.
- Conditions
- Chronic Pain
- Being tested
- Heat Pain Paradigm
- Keywords
- sensory processing sensitivity
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat Pain ParadigmBehavioural
A standardized heat pain paradigm will be applied. Pain threshold will be determined with the self-controlled search method starting at 32°C, with a mouse-click-induced increase of 0.1°C per click. Pain tolerance is defined as the time in seconds elapsed from the onset of the pain stimulus to a participant's withdrawal from the stimulus. Participants will be instructed to continue with the task for as long as they can and to press a button if it becomes too uncomfortable or painful. Temperature will then return to baseline. To avoid physical injury, the measurement will stop automatically at a maximum temperature of 50°C.
| Study group | Role | What they receive |
|---|---|---|
| Positive Mood | This group will be exposed to a positive mood induction prior to heat pain. Receives: Behavioral: Heat Pain Paradigm | |
| Negative Mood | This group will be exposed to a negative mood induction prior to heat pain. Receives: Behavioral: Heat Pain Paradigm | |
| Neutral Mood | This group will be exposed to a neutral mood induction prior to heat pain. Receives: Behavioral: Heat Pain Paradigm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Threshold
Temperature point where participants feel it changing from "hot" to "painful"
Measured: 1 day
Pain Tolerance
the time in seconds elapsed from the onset of the pain stimulus to a participant's withdrawal from the stimulus
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start21 Jun 2021
- Primary completion30 Apr 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Koechlin, University Hospital, Basel, Switzerland
- Investigators
- Helen Koechlin, PhD, Principal investigator, University of Basel, Switzerland; Boston Children's Hospital, Boston, MA, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473014
- Sponsor's protocol ID
- Heat Pain
- Status last verified
- May 2022
- First submitted
- 30 Jun 2020
- Last updated
- 18 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards a Deeper Understanding of Chronic Pediatric Pain: Exploring the Role of Sensory Processing Sensitivity
- ClinicalTrials.gov ID
- NCT04473014
- Acronym / sponsor ID
- Heat Pain
- Conditions
- Chronic Pain
- Keywords
- sensory processing sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 16 Jul 2020 (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.
The aim of this project is to increase scientific understanding of whether the trait of SPS can help explain increased pain sensitivity and hence vulnerability for chronic pain. Additionally, it will be tested whether participants with high SPS report differences in pain intensity in response to positive, negative, or neutral mood induction compared to individuals with lower SPS.
Detailed description
Background: Pain is defined as an unpleasant sensory and emotional experience and in its chronic form, pain is highly prevalent, up to 25% of children and adolescents are affected by it. The exact etiology of many forms of chronic pain remains unknown. One mechanism that has been proposed to underlie increased pain sensitivity is central sensitization, i.e., increased efficacy of the nervous system in transmitting pain signals, which manifests itself as a lower pain threshold. A lower pain threshold in turn has been recognized as a risk factor for the development of chronic pain. Being more sensitive to pain is one feature commonly shared by those with high sensory processing sensitivity (SPS), who are thought to react more strongly to both positive and negative environmental influences. The relationship between this increased sensitivity and pain tolerance has not been studied to date, but could contribute to our understanding of why some children and adolescents are more vulnerable to developing chronic pain than others.
Objectives and Aims: The aim of this project is to increase scientific understanding of whether the trait of SPS can help explain increased pain sensitivity and hence vulnerability for chronic pain. Additionally, it will be tested whether participants with high SPS report differences in pain intensity in response to positive, negative, or neutral mood induction compared to individuals with lower SPS.
Methods: To examine differences in pain perception of an experimentally induced pain stimulus between people with varying levels of SPS and whether pain perception can modulated by positive, negative, or neutral mood induction, I will apply a heat pain paradigm in a sample of healthy adolescents. Participants will be randomized to either neutral, positive or negative mood induction and I will test whether their pain sensitivity differs as a function of their scores on a high sensitivity scale and with regard to mood induction.
Expected Results: We expect highly sensitive adolescents to have a lower pain threshold and tolerance and to react more strongly to positive (with decreased pain ratings) and negative (with increased pain ratings) mood induction compared to those with lower scores on the sensitivity scale.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Positive Mood | – | Behavioral: Heat Pain ParadigmThis group will be exposed to a positive mood induction prior to heat pain. |
| Negative Mood | – | Behavioral: Heat Pain ParadigmThis group will be exposed to a negative mood induction prior to heat pain. |
| Neutral Mood | – | Behavioral: Heat Pain ParadigmThis group will be exposed to a neutral mood induction prior to heat pain. |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants will be recruited from local schools and at the University of Basel, Switzerland.
Key inclusion criteria (1 listed)
- Healthy adolescents aged 16-19 years
Key exclusion criteria (7 listed)
- Chronic pain or another chronic condition
- Skin pathologies
- Sensory abnormalities affecting the tactile or thermal modality
- Pregnancy
- Current medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat Pain ParadigmA standardized heat pain paradigm will be applied. Pain threshold will be determined with the self-controlled search method starting at 32°C, with a mouse-click-induced increase of 0.1°C per click. Pain tolerance is defined as the time in seconds elapsed from the onset of the pain stimulus to a participant's withdrawal from the stimulus. Participants will be instructed to continue with the task for as long as they can and to press a button if it becomes too uncomfortable or painful. Temperature will then return to baseline. To avoid physical injury, the measurement will stop automatically at a maximum temperature of 50°C. | Behavioural | Negative Mood, Neutral Mood, Positive Mood |
Primary outcome
Pain Threshold
Time frame: 1 day
Temperature point where participants feel it changing from "hot" to "painful"
Pain Tolerance
Time frame: 1 day
the time in seconds elapsed from the onset of the pain stimulus to a participant's withdrawal from the stimulus
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 18 May 2022.
- 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.
Helen Koechlin, PhD principal investigator
University of Basel, Switzerland; Boston Children's Hospital, Boston, MA, USA
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, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 7 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 18 May 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 Switzerland. 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?
Pain Threshold (time frame: 1 day). 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?
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 18 May 2022.