Pain Processing In Relation To Breathing

Pain Clinical Trial

Official title:

Potential Influences of Respiration Patterns on Experimental Pain Sensitization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06169917
• Other study ID #: 2023-00518
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: December 2023
• Source: Balgrist University Hospital
• Contact: Petra Schweinhardt, Prof. Dr. med
• Phone: +41 44 510 73 81
• Email: petra.schweinhardt[@]balgrist.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Does resonance frequency breathing influence the autonomic nervous system, compared to baseline and compared to paced breathing at a natural frequency?

3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. over 18 and below 40 years of age

2. good general health

3. able to give informed consent

Exclusion Criteria:

1. 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

2. inability to follow study instructions, e.g. due to language problems

3. Consumption of alcohol, drugs, analgesics within the last 24 h

4. Consumption of no more than 100 mg of caffeine within the last 8 h

5. Scar tissue or generally reduced sensitivity in the designated testing site areas

Additional exclusion criteria for experiments 3 and 4

1. Shoe size < 38

2. Restless-Legs-Syndrome

Related Conditions & MeSH terms

• Central Sensitisation
• Pain

Intervention

Behavioral:
• Paced Resonance Frequency Breathing
Participants are required to pace their breathing to their pre-determined individual resonance frequency.
• Paced Breathing at Natural Frequency
Participants are required to pace their breathing to their pre-determined individual breathing frequency at rest.

Other:
• Heat Stimulations
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).

Locations

Country	Name	City	State
Switzerland	University Hospital Balgrist, University Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	40 minutes
Secondary	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	25 minutes
Secondary	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.	25 minutes
Secondary	Galvanic Skin Potential	Galvanic Skin potential is taken as a reflection of electrodermal activity. The measuring unit of this outcome is microsiemens	25 minutes
Secondary	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	25 minutes