Back to resultsCould Apnea Induce Hypoalgesia?
Primary Purpose
Pain, Apnea
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Apnea
Control Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Pain, Apnoea, Apnea, Hypoalgesia
Eligibility Criteria
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.
Sites / Locations
- Centro Superior de Estudios La Salle
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Experimental Group
Control Group
Arm Description
Experimental Group
Control Group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Rated Perceived Exertion
Apnea and control interventions were explored in terms of Rated Perceived Exertion in with Borg's modified CR-10
Full Information
NCT ID
NCT05991141
First Posted
July 26, 2023
Last Updated
August 11, 2023
Sponsor
Centro Universitario La Salle
1. Study Identification
Unique Protocol Identification Number
NCT05991141
Brief Title
Could Apnea Induce Hypoalgesia?
Official Title
Could Apnea Induce Hypoalgesia? An Explorative Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitario La Salle
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Apnea
Keywords
Pain, Apnoea, Apnea, Hypoalgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Experimental Group
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Control Group
Intervention Type
Other
Intervention Name(s)
Apnea
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pressure Pain Threshold
Description
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.
Time Frame
Before and immediately after the interventions
Secondary Outcome Measure Information:
Title
Conditioned pain modulation
Description
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.
Time Frame
Before and immediately after the interventions
Title
Heart Rate and Oxygen Saturation
Description
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.
Time Frame
During the intervention and for 2 minutes additionally after the end of the intervention
Title
Rated Perceived Exertion
Description
Apnea and control interventions were explored in terms of Rated Perceived Exertion in with Borg's modified CR-10
Time Frame
This outcome was assessed immediately after having finished the intervention protocols
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Fierro Marrero
Organizational Affiliation
CSEULaSalle
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Superior de Estudios La Salle
City
Madrid
ZIP/Postal Code
28023
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Could Apnea Induce Hypoalgesia?
We'll reach out to this number within 24 hrs