Central SensitisationNCT06169917
Pain Processing In Relation To Breathing
A study testing Paced Resonance Frequency Breathing, Paced Breathing at Natural Frequency and Heat Stimulations in people with Central Sensitisation and Pain, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to investigate the effect of breathing on the processing of experimental pain in healthy participants. The main questions are: 1. Does breathing rate influence the spatial extent of thermally induced secondary hyperalgesia, a proxy of central sensitization? 2. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Sensitisation, Pain
- What is being tested?
- Paced Resonance Frequency Breathing, Paced Breathing at Natural Frequency and Heat Stimulations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 May 2023to 31 May 2025
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- over 18 and below 40 years of age
- good general health
- able to give informed consent
Who cannot join
- any major medical or psychiatric condition (e.g. heart disease, diabetes, autoimmune disorders, infectious diseases, major depressive disorder), any chronic pain condition, any respiratory problems, any current acute pain at time of study
- inability to follow study instructions, e.g. due to language problems
- Consumption of alcohol, drugs, analgesics within the last 24 h
- Consumption of no more than 100 mg of caffeine within the last 8 h
- Scar tissue or generally reduced sensitivity in the designated testing site areas
- Additional exclusion criteria for experiments 3 and 4
- Shoe size < 38
- Restless-Legs-Syndrome
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Balgrist, University Zürich
Zurich, 8008
Petra Schweinhardt, Prof. Dr. med, +41 44 510 73 81, petra.schweinhardt@balgrist.ch
About this study
Official title: Potential Influences of Respiration Patterns on Experimental Pain Sensitization
The goal of this clinical trial is to investigate the effect of breathing on the processing of experimental pain in healthy participants. The main questions are:
- Does breathing rate influence the spatial extent of thermally induced secondary hyperalgesia, a proxy of central sensitization?
- Does resonance frequency breathing influence the autonomic nervous system, compared to baseline and compared to paced breathing at a natural frequency?
- Is spinal excitability, measured using the magnitude of the nociception withdrawal reflex (NWR), affected by resonance frequency breathing, compared to paced breathing at a natural frequency?
Read more
Participants:
- will receive heat stimuli
- 's skin's sensitivity will be tested using quantitative sensory testing tools.
- will receive various instructions on the speed of their breathing
- 's heart rate, respiratory rate and sweat response will be measured
- will fill in questionnaires
Researchers will compare the spatial extent of sensitivity resulting from application of heat stimuli during paced resonance frequency breathing compared to paced breathing at a natural frequency to see if the breathing rhythm influences central sensitization processes.
- Conditions
- Central Sensitisation, Pain
- Being tested
- Paced Resonance Frequency Breathing, Paced Breathing at Natural Frequency, Heat Stimulations
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paced Resonance Frequency BreathingBehavioural
Participants are required to pace their breathing to their pre-determined individual resonance frequency.
Paced Breathing at Natural FrequencyBehavioural
Participants are required to pace their breathing to their pre-determined individual breathing frequency at rest.
Heat StimulationsOther
Participants will undergo a heat stimulation procedure on their left and right foot (the order of which is counterbalanced across participants). During this procedure, there are 10 blocks, with an inter-stimulus interval of 30 seconds between two blocks. During a block, six 6-second heat stimulations (48 degrees) are given. Between the stimulations, the temperature quickly returns to baseline (32 degrees).
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Experimental | Participants should be aged 18-40, in good health, capable of informed consent, without major medical/psychiatric conditions (e.g., heart disease, diabetes, autoimmune disorders, infectious diseases, major depressive disorder), chronic pain, respiratory issues, or ongoing acute pain, qualify. Exclusions: inability to follow instructions (e.g., language issues), recent alcohol/drug/analgesic use (<24h), caffeine intake (>100mg <8h), or scar tissue/general reduced sensitivity in test areas.
Participants undergo three interventions. The heat stimulation intervention is performed twice. During one heat stimulation intervention, participants receive the 'resonance frequency breathing' intervention. During the other heat stimulation intervention, participants receive the 'natural frequency breathing' intervention. The order of the breathing interventions is counterbalanced across participants. Receives: Behavioral: Paced Resonance Frequency Breathing; Behavioral: Paced Breathing at Natural Frequency; Other: Heat Stimulations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area of Hypersensitivity surrounding the primary stimulation site
Before and after thermal stimulations, the sensitivity of the skin is tested using a von Frey Filament, a Pin Prick and a brush. Thermal stimulations cause hypersensitivity of the skin, resulting in an area of hypersensitivity surrounding the stimulation site. The primary outcome measure is the amount of change in the area of hypersensitivity from before to after the thermal stimulations. The measuring unit of this outcome is square centimetres.
Measured: 40 minutes
Secondary outcomes (4)
Power in the Low-frequency Range of the Heart Rate Variability
Power is measured in units of milliseconds squared (ms 2) for a the low frequency band (Hz), ranging from 0.04 - 0.15Hz
Measured: 25 minutes
Root Mean Square of Successive Differences of the Heart Rate Variability
The measuring unit to measure heart rate variability is the root mean square of successive differences between normal heartbeats.
Measured: 25 minutes
Galvanic Skin Potential
Galvanic Skin potential is taken as a reflection of electrodermal activity. The measuring unit of this outcome is microsiemens
Measured: 25 minutes
Threshold and Magnitude of the Nociceptive Withdrawal Reflex
The nociceptive withdrawal reflex is triggered using an supratheshold electrical stimulation at the nervus suralis leading muscle contraction in the ipsilateral biceps femoris, rectus femoris and tibialis anterior. Muscle contraction is measures in millivolt using electromyogram with recording electrodes attached to the respective muscles
Measured: 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start14 May 2023
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central SensitisationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Schweinhardt Petra, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169917
- Sponsor's protocol ID
- 2023-00518
- Other IDs
- 2023
- Status last verified
- Dec 2023
- First submitted
- 4 Sep 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- 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 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Influences of Respiration Patterns on Experimental Pain Sensitization
- ClinicalTrials.gov ID
- NCT06169917
- Acronym / sponsor ID
- 2023-00518
- Conditions
- Central Sensitisation, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 14 May 2023 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 14 Dec 2023 (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 goal of this clinical trial is to investigate the effect of breathing on the processing of experimental pain in healthy participants. The main questions are:
- Does breathing rate influence the spatial extent of thermally induced secondary hyperalgesia, a proxy of central sensitization?
- Does resonance frequency breathing influence the autonomic nervous system, compared to baseline and compared to paced breathing at a natural frequency?
- Is spinal excitability, measured using the magnitude of the nociception withdrawal reflex (NWR), affected by resonance frequency breathing, compared to paced breathing at a natural frequency?
Participants:
- will receive heat stimuli
- 's skin's sensitivity will be tested using quantitative sensory testing tools.
- will receive various instructions on the speed of their breathing
- 's heart rate, respiratory rate and sweat response will be measured
- will fill in questionnaires
Researchers will compare the spatial extent of sensitivity resulting from application of heat stimuli during paced resonance frequency breathing compared to paced breathing at a natural frequency to see if the breathing rhythm influences central sensitization processes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | Experimental | Behavioral: Paced Resonance Frequency Breathing, Behavioral: Paced Breathing at Natural Frequency, Other: Heat StimulationsParticipants should be aged 18-40, in good health, capable of informed consent, without major medical/psychiatric conditions (e.g., heart disease, diabetes, autoimmune disorders, infectious diseases, major depressive disorder), chronic pain, respiratory issues, or ongoing acute pain, qualify. Exclusions: inability to follow instructions (e.g., language issues), recent alcohol/drug/analgesic use (<24h), caffeine intake (>100mg <8h), or scar tissue/general reduced sensitivity in test areas. Participants undergo three interventions. The heat stimulation intervention is performed twice. During one heat stimulation intervention, participants receive the 'resonance frequency breathing' intervention. During the other heat stimulation intervention, participants receive the 'natural frequency breathing' intervention. The order of the breathing interventions is counterbalanced across participants. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- over 18 and below 40 years of age
- good general health
- able to give informed consent
Key exclusion criteria (8 listed)
- any major medical or psychiatric condition (e.g. heart disease, diabetes, autoimmune disorders, infectious diseases, major depressive disorder), any chronic pain condition, any respiratory problems, any current acute pain at time of study
- inability to follow study instructions, e.g. due to language problems
- Consumption of alcohol, drugs, analgesics within the last 24 h
- Consumption of no more than 100 mg of caffeine within the last 8 h
- Scar tissue or generally reduced sensitivity in the designated testing site areas
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 |
|---|---|---|
| Paced Resonance Frequency BreathingParticipants are required to pace their breathing to their pre-determined individual resonance frequency. | Behavioural | Healthy participants |
| Paced Breathing at Natural FrequencyParticipants are required to pace their breathing to their pre-determined individual breathing frequency at rest. | Behavioural | Healthy participants |
| Heat StimulationsParticipants will undergo a heat stimulation procedure on their left and right foot (the order of which is counterbalanced across participants). During this procedure, there are 10 blocks, with an inter-stimulus interval of 30 seconds between two blocks. During a block, six 6-second heat stimulations (48 degrees) are given. Between the stimulations, the temperature quickly returns to baseline (32 degrees). | Other | Healthy participants |
Primary outcome
Area of Hypersensitivity surrounding the primary stimulation site
Time frame: 40 minutes
Before and after thermal stimulations, the sensitivity of the skin is tested using a von Frey Filament, a Pin Prick and a brush. Thermal stimulations cause hypersensitivity of the skin, resulting in an area of hypersensitivity surrounding the stimulation site. The primary outcome measure is the amount of change in the area of hypersensitivity from before to after the thermal stimulations. The measuring unit of this outcome is square centimetres.
4 secondary outcomes
Power in the Low-frequency Range of the Heart Rate Variability
Time frame: 25 minutes
Root Mean Square of Successive Differences of the Heart Rate Variability
Time frame: 25 minutes
Galvanic Skin Potential
Time frame: 25 minutes
Threshold and Magnitude of the Nociceptive Withdrawal Reflex
Time frame: 25 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paced Resonance Frequency Breathing, Paced Breathing at Natural Frequency and Heat Stimulations in people with Central Sensitisation and Pain, run by Balgrist University Hospital 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 14 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Petra Schweinhardt, Prof. Dr. med (+41 44 510 73 81, petra.schweinhardt@balgrist.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area of Hypersensitivity surrounding the primary stimulation site (time frame: 40 minutes). 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 14 Dec 2023.