Pain Inhibitory Effects of a Single Painful Mechanical Stimulus Compared to Multiple and Multiple at Different Locations

Sponsor

Josue Fernandez Carnero (Other)

Overall Status

Recruiting

CT.gov ID

NCT05730179

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Days)

23.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective is to estimate the effects on pain thresholds of a single painful mechanical stimulus compared to multiple and multiple stimuli at different locations.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Mechanical Conditioning stimulus	N/A

Detailed Description

The mechanical stimulus produced in manual therapy (MT) techniques elicits neurophysiological responses within the peripheral and central nervous system responsible for pain inhibition. Almost all types of MT elicit a neurophysiological response that is associated with the descending pain modulation circuit. But it has not been demonstrated whether this inhibition occurs through a conditioned pain modulation mechanism induced by painful mechanical stimulation that is carried out with manual therapy techniques.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Conditioned Pain Modulation Induced by Mechanical Stimulation: A Mechanism of Manual Therapy Analgesia - Study 3

Actual Study Start Date :

Feb 15, 2023

Anticipated Primary Completion Date :

Mar 15, 2023

Anticipated Study Completion Date :

Mar 17, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mechanical stimulation Mechanical compression is applied with the thumb to the upper trapezius muscle on the non-dominant side at the midpoint between the acromion and C7. The intensity of this will be regulated by the pain it causes the patient, trying to ensure that it is at all times approximately 5/10 on the numerical pain rating scale (NPRS) with 0 being "no pain at all" and 10 being "the worst pain imaginable". The stimulation will be carried out for 2 minutes.	Other: Mechanical Conditioning stimulus Painful mechanical stimulus
Active Comparator: Repeated mechanical stimulation Mechanical compression is applied with the thumb to the upper trapezius muscle on the non-dominant side at the midpoint between the acromion and C7. The intensity of this will be regulated by the pain it causes the patient, trying to ensure that it is at all times approximately 2/10 on the numerical pain rating scale (NPRS) with 0 being "no pain at all" and 10 being "the worst pain imaginable". The stimulation will be performed for 2 minutes 4 times with 1 minute rest.	Other: Mechanical Conditioning stimulus Painful mechanical stimulus
Active Comparator: Repeated mechanical stimulation at different locations Mechanical compression is applied with the thumb. The intensity of this will be regulated by the pain it causes the patient, trying to ensure that it is at all times approximately 2/10 on the numerical pain rating scale (NPRS) with 0 being "no pain at all" and 10 being "the worst pain imaginable". Stimulation will be performed for 2 minutes, 4 times, at four different sites (left and right upper trapezius and left and right lumbar paravertebral) with 1 minute of rest.	Other: Mechanical Conditioning stimulus Painful mechanical stimulus

Arm

Intervention/Treatment

Active Comparator: Mechanical stimulation

Mechanical compression is applied with the thumb to the upper trapezius muscle on the non-dominant side at the midpoint between the acromion and C7. The intensity of this will be regulated by the pain it causes the patient, trying to ensure that it is at all times approximately 5/10 on the numerical pain rating scale (NPRS) with 0 being "no pain at all" and 10 being "the worst pain imaginable". The stimulation will be carried out for 2 minutes.

Other: Mechanical Conditioning stimulus

Painful mechanical stimulus

Active Comparator: Repeated mechanical stimulation

Mechanical compression is applied with the thumb to the upper trapezius muscle on the non-dominant side at the midpoint between the acromion and C7. The intensity of this will be regulated by the pain it causes the patient, trying to ensure that it is at all times approximately 2/10 on the numerical pain rating scale (NPRS) with 0 being "no pain at all" and 10 being "the worst pain imaginable". The stimulation will be performed for 2 minutes 4 times with 1 minute rest.

Other: Mechanical Conditioning stimulus

Painful mechanical stimulus

Active Comparator: Repeated mechanical stimulation at different locations

Mechanical compression is applied with the thumb. The intensity of this will be regulated by the pain it causes the patient, trying to ensure that it is at all times approximately 2/10 on the numerical pain rating scale (NPRS) with 0 being "no pain at all" and 10 being "the worst pain imaginable". Stimulation will be performed for 2 minutes, 4 times, at four different sites (left and right upper trapezius and left and right lumbar paravertebral) with 1 minute of rest.

Other: Mechanical Conditioning stimulus

Painful mechanical stimulus

Outcome Measures

Primary Outcome Measures

Change from Baseline in Tibialis Anterior Pressure Pain Threshold (PPT) to immediate post-conditioning stimulus [At baseline and immediately after the conditioning stimulus]
PPTs will be assessed on the dominant side over the tibialis anterior muscle using a digital algometer (Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful. The average of 3 assessments on the tibialis anterior of the dominant side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

healthy male or female between 18 and 65 years
Free of pain and with no history of chronic pain

Exclusion Criteria:

Pregnant or having given birth within the last year

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad Rey Juan Carlos	Alcorcón	Madrid	Spain	28047

Sponsors and Collaborators

Josue Fernandez Carnero

Investigators

Principal Investigator: Josué Fernández Carnero, PhD, Universidad Rey Juan Carlos

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Josue Fernandez Carnero, Professor, Universidad Rey Juan Carlos

ClinicalTrials.gov Identifier:

NCT05730179

Other Study ID Numbers:

MechCPM3

First Posted:

Feb 15, 2023

Last Update Posted:

Feb 17, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Josue Fernandez Carnero, Professor, Universidad Rey Juan Carlos

Conditioned Pain Modulation

Manual Therapy

Physiotherapy

Physical therapy

Study Results

No Results Posted as of Feb 17, 2023