- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07551687
Pleasant Touch Perception in Persistent Pain.
Being Touched in Persistent Pain: Mapping the Association Between Pleasant Touch and Central Sensitization in Patients With Persistent Pain.
The goal of this observational study is to learn how individuals with chronic pain experience pleasant touch and how often they are exposed to such touch in their daily lives. The study also aims to examine how these experiences relate to pain sensitivity and body awareness. The main questions it aims to answer are:
How is the perception of pleasant touch associated with central sensitization and interoceptive awareness in individuals with chronic pain?
Does the perception of pleasant touch differ between individuals with different dominant pain mechanisms (nociceptive, neuropathic, and nociplastic)?
Participants referred to a specialist Pain Clinic in Västra Götaland as part of their regular care will be invited to take part. Those who consent will complete online questionnaires assessing pain, experience and exposure to touch, interoceptive awareness, and central sensitization. Clinical data such as pain diagnosis and medical history will also be collected.
Study Overview
Status
Conditions
Detailed Description
This observational study aims to investigate how individuals with chronic pain experience pleasant touch and how these experiences relate to central sensitization, interoceptive awareness, and different pain mechanisms.
Participants referred to the Pain Clinic in Västra Götaland as part of their regular care will be invited to participate. After receiving written and oral information and providing informed consent, participants will complete digital questionnaires via a secure electronic data capture system (REDCap).
The questionnaires assess experience and exposure to pleasant social touch, central sensitization (Central Sensitization Inventory, CSI), interoceptive awareness (Multidimensional Assessment of Interoceptive Awareness, MAIA-2), and pain intensity (Numeric Pain Rating Scale, NPRS). A newly developed questionnaire will be used to assess perception and exposure to social touch, including qualitative components.
Clinical data will be collected during routine physician visits and include pain diagnosis, pain distribution, symptom severity, comorbidities, and medication use. Questionnaire data and clinical data will be linked using participant ID numbers. Treating physicians will not have access to questionnaire responses to reduce the risk of bias.
Additional data may be obtained from the Swedish National Registry for Pain Rehabilitation (NRS), where applicable.
A total of 100 participants will be included. Based on previous registry data and similar studies, subgroup sizes are expected to be sufficient to allow comparisons between individuals with different dominant pain mechanisms (e.g., nociceptive, neuropathic, and nociplastic pain).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Line Löken, PhD
- Phone Number: +46706722713
- Email: line.loken@gu.se
Study Locations
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Gothenburg, Sweden
- Smärtteam Västra Götaland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18 years and older
- Referred to and accepted for assessment at Pain Clinic (Smärtteam) Västra Götaland due to persistent pain (duration ≥ 3 months)
- Able to read and complete self-report questionnaires in Swedish
Exclusion Criteria:
- Inability to read or complete self-report questionnaires in Swedish
- Need for interpreter support
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Chronic Pain Patients
Individuals with chronic pain referred to a specialist pain clinic in Västra Götaland.
Participants will complete questionnaires assessing pain, experience and exposure to pleasant touch, interoceptive awareness, and central sensitization.
Clinical data will be collected as part of routine care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Perception of pleasant touch
Time Frame: At baseline
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Perception of pleasant touch assessed using a study-specific questionnaire measuring experience and exposure to social touch.
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At baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Central sensitization
Time Frame: At baseline
|
Central sensitization measured using the Central Sensitization Inventory (CSI).
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At baseline
|
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Interoceptive awareness
Time Frame: At baseline
|
Interoceptive awareness assessed using the Multidimensional Assessment of Interoceptive Awareness (MAIA-2).
|
At baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-08467-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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