Prolonged Pain, EEG, Resting State Functional ConnectivityNCT05158309
Measuring and Modulating Changes in EEG Resting State Functional Connectivity During Short-term and Long-term Pain
A study testing 8% Capsaicin patch in people with Prolonged Pain, EEG, Resting State Functional Connectivity, run by Aalborg University at 1 site in Denmark.
Trial summary
Background and aims: Experimental prolonged pain models can shed more light on the cortical mechanisms involved in the transition from acute to chronic pain including changes in resting state functional connectivity (rsFC). Read more about this study
- Who is it for?
- Ages 19 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Prolonged Pain, EEG, Resting State Functional Connectivity
- What is being tested?
- 8% Capsaicin patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 31 May 2021to 6 Nov 2021
- Phase
- Interventional
- 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 19 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women, age 19-44, right-handed (assessed using the Edinburgh Handedness Inventory, speak and understand English.
Who cannot join
- Chili allergies
- History of chronic pain or current acute pain
- Present or previous neurologic such as epilepsy, Alzheimer disease, dementia, stroke, migraine and other headache disorders, multiple sclerosis, Parkinson's disease, neuroinfections, brain tumours and head trauma.
- Present or previous musculoskeletal disorders such muscle/tendon strain, ligament sprain tension,tendonitis, degenerative disc disease, mechanical back syndrome, and ruptured/herniated disc.
- Present or previous mental illnesses such as depression, bipolar disorder, and schizophrenia.
- Pregnancy
Show all 11Show fewer
- Current use of medications that may affect the trial (e.g. pain relieving medication and anti-inflammatory medication)
- Using hair products that may interfere with EEG conductance such as gel, except for shampoo, prior to the trial.
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Consumption of alcohol, caffeine, or tobacco 6 hours before the experimental onset
- Lack of ability to cooperate -
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aalborg University, Department of Health Sciences and technology
Aalborg, 9220
About this study
Official title: Aalborg University, Aalborg, Denmark
Background and aims: Experimental prolonged pain models can shed more light on the cortical mechanisms involved in the transition from acute to chronic pain including changes in resting state functional connectivity (rsFC). This experiment aimed at examining the effect of 24-hour-capsaicin application on the rsFC of the default mode network (DMN), a prominent network in the dynamic pain connectome.
Methods: Electroencephalographic (EEG) rsFC measured by Granger causality was acquired at baseline, 1-hour, and 24-hour following the initial patch application (placebo or capsaicin). After 24 hours, the patch was cooled down then heated up to assess rsFC changes in response to pain relief and facilitation. Pain was induced using a topical capsaicin patch (or placebo as control) on the right forearm and assessed on a 0-10 numerical rating scale (NRS).
- Being tested
- 8% Capsaicin patch, placebo patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8% Capsaicin patchOther
Cutaneous pain was induced using a (5x10 cm) 8% topical capsaicin patch (transdermal patch, 'Qutenza', Astellas) on the volar part of the dominant right forearm (5 cm from the wrist) of each participant.
placebo patchOther
A transparent patch with no formulation or effect but the same size of the capsaicin patch was applied to the same location.
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin | Experimental | Capsaicin condition: in this condition participants received pain using a (5x10 cm) 8% topical capsaicin patch on the volar part of the dominant right forearm. Receives: Other: 8% Capsaicin patch |
| Placebo | Placebo comparator | Placebo condition: participants received no pain. Receives: Other: placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in resting state functional connectivity
resting state functional connectivity is assessed using Granger causality. It can take on any value starting with "0" representing no connectivity. Higher granger causality scores indicate higher connectivity.
Measured: Granger causality is assessed at 5 time points for each condition (capsaicin or placebo): baseline, 1 hour, 24 hours, 24 hours, cooling at 24hours, and heating at 24 hours.
Change in Subjective pain intensity
Intensity rated by the participants on a numerical rating scale anchoring from 0 "no pain" to 10 "the worst imaginable pain" . Higher numerical rating scores indicate higher pain intensity.
Measured: Intensity is assessed at 5 time points for each condition (capsaicin or placebo): baseline, 1 hour, 24 hours, cooling at 24hours, and heating at 24 hours.
Secondary outcomes (11)
Change in Pain sensitivity (Warmth detection threshold)
Warmth detection threshold is assessed using a thermal stimulator probe (3 × 3 cm, Pathway Medoc Ltd, Israel). Higher threshold scores indicate less sensitivity.
.
Measured: Warmth detection threshold is assessed at 3 time points for each condition (capsaicin or placebo): baseline, 1 hour, and 24 hours.
Change in Pain sensitivity ( Cold detection threshold).
Cold detection threshold is assessed using a thermal stimulator probe (3 × 3 cm, Pathway Medoc Ltd, Israel). Higher threshold scores indicate less sensitivity.
Measured: Warmth detection threshold is assessed at 3 time points for each condition (capsaicin or placebo): baseline, 1 hour, and 24 hours.
Change in Pain sensitivity ( Heat pain threshold).
Heat detection threshold is assessed using a thermal stimulator probe (3 × 3 cm, Pathway Medoc Ltd, Israel). Higher threshold scores indicate less sensitivity.
Measured: Heat pain threshold is assessed at 3 time points for each condition (capsaicin or placebo): baseline, 1 hour, and 24 hours.
Change in Pain sensitivity ( Cold pain thresholds).
Cold pain threshold is assessed using a thermal stimulator probe (3 × 3 cm, Pathway Medoc Ltd, Israel). Higher threshold scores indicate less sensitivity.
Measured: Cold pain threshold is assessed at 3 time points for each condition (capsaicin or placebo): baseline, 1 hour, and 24 hours.
Change in Pain sensitivity ( Mechanical pain thresholds).
Mechanical pain thresholds was assessed using a set of seven weighted pinprick stimulators consisting of steel tubes ending with a tip contact area of 0.25 mm diameter and excreting forces of 0.8, 1.6, 3.2, 6.4, 12.8, 25.6, and 51.2 g. Higher threshold scores indicate less sensitivity.
Measured: Mechanical pain threshold is assessed at 3 time points for each condition (capsaicin or placebo): baseline, 1 hour, and 24 hours.
Pain vigilance
Pain Vigilance and Awareness Questionnaire (PVAQ). This questionnaire consists of 16 items evaluating preoccupation and attention to one's pain over the past two weeks, rated between 0 = "never" and 5 = "always", with a maximum score of 80. The higher the scores, the higher the preoccupation with pain.
Measured: It is assessed at baseline and after 24 hours for each condition (capsaicin or placebo).
Pain Catastrophizing
Scale (PCS). This questionnaire comprises 13 items assessed on a 5-point scale ranging from 0 = "not at all" to 4 = "all the time", with a maximum score of 52. It evaluates three scales of catastrophizing: rumination, magnification, and helplessness. Ratings reflect the degree to which specific thoughts and feelings are present when experiencing pain over the last three months. Higher scores indicate a higher degree of pain catastrophizing.
Measured: It is assessed at baseline and after 24 hours for each condition (capsaicin or placebo).
Sleep quality assessment
Pittsburgh Sleep Quality Index (PSQI). This questionnaire determines sleep quality and sleep patterns across seven areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction over the last month. These areas are evaluated on a scale ranging from 0 = "no difficulty" to 3 = "severe difficulty," with a maximum score of 21. Higher scores reflect poor sleep quality.
Measured: It is assessed at baseline and after 24 hours for each condition (capsaicin or placebo).
Fatigue assessment
Modified Fatigue Impact Scale (MFIS). The MFIS evaluates the degree to which fatigue influences overall perceived function over the last 4 weeks. It assesses three subscales: cognitive (9 items), physical (10 items), and psychosocial (2 items) functioning. Items are measured on a scale from 0 = "no problem" to 4 = "extreme problem", with a maximum score of 120. Higher scores indicate higher levels of fatigue.
Measured: It is assessed at baseline and after 24 hours for each condition (capsaicin or placebo).
Positive and negative affect
Positive and Negative Affect Scale (PANAS). This scale consists of 20 items assessing two groups of emotions: negative and positive (10 items each). Subjects rate the intensity of a specific emotion they are experiencing at the moment on a scale (1 = "very slightly or not at all" to 5 = "Extremely"). for each emotion group with a maximum of 50. Higher scores indicate more intense emotions. The positive affect items were "interested," "excited," "strong," "enthusiastic," "proud," "alert," "inspired," "determined," "attentive," and "active." The negative affect items were "distressed," "upset," "guilty," "scared," "hostile," "irritable," "ashamed," "nervous," "jittery," and "afraid."
Measured: They are assessed at baseline and after 24 hours for each condition (capsaicin or placebo).
Depression scores
Beck Depression Inventory (BDI-II). The BDI determines the severity of depressive mood states and consists of 21 questions assessing hopelessness, guilt, fatigue, and other physical symptoms, rated between 0 = "no symptom impact" and 3 = "maximum symptom impact" with a maximum score of 63. Higher scores indicate severe depressive symptoms. To obtain measures of trait depression, subjects in this study are instructed to rate the items in relation to how they generally feel.
Measured: They are assessed at baseline and after 24 hours for each condition (capsaicin or placebo).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start31 May 2021
- Primary completion6 Nov 2021
- Study completion6 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged Pain, EEG, Resting State Functional ConnectivityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Participants experienced both experimental (capsaicin) condition and placebo conditions. Due to the long-lasting effects of capsaicin after 24 hours of application, placebo condition always preceded the capsaicin condition.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Danish National Research Foundation, European Commission
- Responsible party
- Principal investigator, Najah Al Hajri, Aalborg University
- Investigators
- Thomas Graven-Nielsen, DMSc, PhD, Study director, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158309
- Sponsor's protocol ID
- N-20190057
- Status last verified
- Mar 2022
- First submitted
- 13 Dec 2021
- Last updated
- 15 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No personal data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aalborg University, Aalborg, Denmark
- ClinicalTrials.gov ID
- NCT05158309
- Acronym / sponsor ID
- N-20190057
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Danish National Research Foundation, European Commission
- Study start
- 31 May 2021 (actual)
- Primary completion
- 6 Nov 2021 (actual)
- Study completion
- 6 Nov 2021 (actual)
- First posted
- 15 Dec 2021 (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.
Background and aims: Experimental prolonged pain models can shed more light on the cortical mechanisms involved in the transition from acute to chronic pain including changes in resting state functional connectivity (rsFC). This experiment aimed at examining the effect of 24-hour-capsaicin application on the rsFC of the default mode network (DMN), a prominent network in the dynamic pain connectome.
Methods: Electroencephalographic (EEG) rsFC measured by Granger causality was acquired at baseline, 1-hour, and 24-hour following the initial patch application (placebo or capsaicin). After 24 hours, the patch was cooled down then heated up to assess rsFC changes in response to pain relief and facilitation. Pain was induced using a topical capsaicin patch (or placebo as control) on the right forearm and assessed on a 0-10 numerical rating scale (NRS).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants experienced both experimental (capsaicin) condition and placebo conditions. Due to the long-lasting effects of capsaicin after 24 hours of application, placebo condition always preceded the capsaicin condition.
| Arm | Type | Receives |
|---|---|---|
| Capsaicin | Experimental | Other: 8% Capsaicin patchCapsaicin condition: in this condition participants received pain using a (5x10 cm) 8% topical capsaicin patch on the volar part of the dominant right forearm. |
| Placebo | Placebo comparator | Other: placebo patchPlacebo condition: participants received no pain. |
Who may qualify
- Ages
- 19 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy men and women, age 19-44, right-handed (assessed using the Edinburgh Handedness Inventory, speak and understand English.
Key exclusion criteria (11 listed)
- Chili allergies
- History of chronic pain or current acute pain
- Present or previous neurologic such as epilepsy, Alzheimer disease, dementia, stroke, migraine and other headache disorders, multiple sclerosis, Parkinson's disease, neuroinfections, brain tumours and head trauma.
- Present or previous musculoskeletal disorders such muscle/tendon strain, ligament sprain tension,tendonitis, degenerative disc disease, mechanical back syndrome, and ruptured/herniated disc.
- Present or previous mental illnesses such as depression, bipolar disorder, and schizophrenia.
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 |
|---|---|---|
| 8% Capsaicin patchCutaneous pain was induced using a (5x10 cm) 8% topical capsaicin patch (transdermal patch, 'Qutenza', Astellas) on the volar part of the dominant right forearm (5 cm from the wrist) of each participant. | Other | Capsaicin |
| placebo patchA transparent patch with no formulation or effect but the same size of the capsaicin patch was applied to the same location. | Other | Placebo |
Primary outcome
Change in resting state functional connectivity
Time frame: Granger causality is assessed at 5 time points for each condition (capsaicin or placebo): baseline, 1 hour, 24 hours, 24 hours, cooling at 24hours, and heating at 24 hours.
resting state functional connectivity is assessed using Granger causality. It can take on any value starting with "0" representing no connectivity. Higher granger causality scores indicate higher connectivity.
Change in Subjective pain intensity
Time frame: Intensity is assessed at 5 time points for each condition (capsaicin or placebo): baseline, 1 hour, 24 hours, cooling at 24hours, and heating at 24 hours.
Intensity rated by the participants on a numerical rating scale anchoring from 0 "no pain" to 10 "the worst imaginable pain" . Higher numerical rating scores indicate higher pain intensity.
11 secondary outcomes
Change in Pain sensitivity (Warmth detection threshold)
Time frame: Warmth detection threshold is assessed at 3 time points for each condition (capsaicin or placebo): baseline, 1 hour, and 24 hours.
Change in Pain sensitivity ( Cold detection threshold).
Time frame: Warmth detection threshold is assessed at 3 time points for each condition (capsaicin or placebo): baseline, 1 hour, and 24 hours.
Change in Pain sensitivity ( Heat pain threshold).
Time frame: Heat pain threshold is assessed at 3 time points for each condition (capsaicin or placebo): baseline, 1 hour, and 24 hours.
Change in Pain sensitivity ( Cold pain thresholds).
Time frame: Cold pain threshold is assessed at 3 time points for each condition (capsaicin or placebo): baseline, 1 hour, and 24 hours.
Change in Pain sensitivity ( Mechanical pain thresholds).
Time frame: Mechanical pain threshold is assessed at 3 time points for each condition (capsaicin or placebo): baseline, 1 hour, and 24 hours.
Pain vigilance
Time frame: It is assessed at baseline and after 24 hours for each condition (capsaicin or placebo).
Pain Catastrophizing
Time frame: It is assessed at baseline and after 24 hours for each condition (capsaicin or placebo).
Sleep quality assessment
Time frame: It is assessed at baseline and after 24 hours for each condition (capsaicin or placebo).
Fatigue assessment
Time frame: It is assessed at baseline and after 24 hours for each condition (capsaicin or placebo).
Positive and negative affect
Time frame: They are assessed at baseline and after 24 hours for each condition (capsaicin or placebo).
Depression scores
Time frame: They are assessed at baseline and after 24 hours for each condition (capsaicin or placebo).
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 15 Mar 2022.
- Individual participant dataSharing planned: Undecided. No personal data will be shared
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.
Thomas Graven-Nielsen, DMSc, PhD study director
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8% Capsaicin patch in people with Prolonged Pain, EEG, Resting State Functional Connectivity, run by Aalborg University at 1 site in Denmark.
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 11 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 15 Mar 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Change in resting state functional connectivity (time frame: Granger causality is assessed at 5 time points for each condition (capsaicin or placebo): baseline, 1 hour, 24 hours, 24 hours, cooling at 24hours, and heating at 24 hours.). 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 15 Mar 2022.