Could Apnea Induce Hypoalgesia?

Pain Clinical Trial

Official title:

Could Apnea Induce Hypoalgesia? An Explorative Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05991141
• Other study ID #: CSEULS-PI-029/2022
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: May 15, 2023

Study information

• Verified date: August 2023
• Source: Centro Universitario La Salle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized controlled trial (RCT) in healthy subjects will be conducted with the following aims: (1) Explore the effect of low pulmonary volume dynamic apnoea bouts on Pressure Pain Threshold (PPT) and conditioned pain modulation (CPM); (2) analyse whether CPM response correlates with apnoea induced hypoalgesia; (3) examine the association between apnoea bouts, Rate of Perceived Exertion, hypoxemia and Heart Rate changes in PPT.

Description:

A randomized controlled trial (RCT) in healthy subjects will be conducted with the following aims: (1) Explore the effect of low pulmonary volume dynamic apnoea bouts on Pressure Pain Threshold (PPT) and conditioned pain modulation (CPM); (2) analyse whether CPM response correlates with apnoea induced hypoalgesia; (3) examine the association between apnoea bouts Rate of Perceived Exertion, hypoxemia and Heart Rate changes in PPT

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Healthy participants

• 18-30 years

• Currently pain-free

• Basal SpO2 =95%

Exclusion Criteria:

• Diabetes diagnosis

• Hypertension or hypotension diagnosis

• Pharmacological treatment

• Frequent pain during last month

• Drug consumption

• Self-harming behaviours

• Pregnant or potentially pregnant

• Cardiac or respiratory pathology

• Splenectomy or spleen disease

• Having performed moderate or high intensity physical activity 24 hours prior to the study

• Not having slept the previous night

• Alcohol intake 24 hours prior to study.

Related Conditions & MeSH terms

• Apnea
• Pain

Intervention

Other:
• Apnea
In both experimental and control groups participants walked on a treadmill at 5.5 km/h with 5º inclination for 6 minutes. The experimental group (EG) added throughout the 6 minutes intervention the following breathing pattern cyclically: 5 seconds breathing normally followed by 10 seconds of low volume apnoea, performing a total of 24 cycles of normal breathing continued by apnoea.
• Control Intervention
In both experimental and control groups participants walked on a treadmill at 5.5 km/h with 5º inclination for 6 minutes. The Control group (CG) performed this protocol breathing normally.

Locations

Country	Name	City	State
Spain	Centro Superior de Estudios La Salle	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitario La Salle

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure Pain Threshold	PPT refers to the minimal amount of pressure needed to cause the first sensation of pain. The mechanical pressure algometer (PAIN TEST™ FPX 25, Wagner Instruments, Greenwich, CT, USA) counted with a round rubber disc of 1 cm2, displaying values in Kg, hence, data was expressed in Kg/cm2. Two locations, in upper and lower limbs, were examined to examine systemic hypoalgesia effects. The dorsal distal-phalange base of the thumb and tibialis anterior muscle belly, both in the dominant limb, were tested. These regions were marked with a pen before assessments, to repeat the trials in the same place. Three trials were tested in each location, with 30 seconds rest between trials. Pressure speed was paced with a metronome applying a constant force of 0.5 Kg/cm2/s ± 0.1 Kg/cm2/s.	Before and immediately after the interventions
Secondary	Conditioned pain modulation	Conditioning stimulus was applied on the contralateral limb to test stimulus, since its arrangement does not influence CPM response. Only controversial CPM response have appeared when tests and conditioned stimuli were applied on the same body region. Ischemic pain was applied as conditioning stimulus and PPT as test stimulus. Ischemic pain was provoked inflating a sphygmomanometer at the proximal region of the non-dominant arm. When inflated up to 180-200 mmHg patients were asked to actively move fingers and wrist. They were asketd to report when a 7/10 pain in Numerical Pain Rating Scale (NPRS) scale was reached. In that moment, three trials of test stimuli were applied on the dorsal distal-phalange base of the thumb in the dominant arm, while maintaining the ischemic pain perception.	Before and immediately after the interventions
Secondary	Heart Rate and Oxygen Saturation	We video-taped HR and SpO2 values during the 6 min interventions and 2 minutes afterwards to explore their changes during and after interventions. HR and SpO2 data were extracted in each second. These values would be graphically displayed. Peak %HRmax and minimum SpO2, and means of both variables, value would be extracted from the 6-minute interventions. HR zones or exercise-induced hypoxemia zones were also recorded.	During the intervention and for 2 minutes additionally after the end of the intervention
Secondary	Rated Perceived Exertion	Apnea and control interventions were explored in terms of Rated Perceived Exertion in with Borg's modified CR-10	This outcome was assessed immediately after having finished the intervention protocols