Pain Inhibitory Effects of Other Pain Induced by Mechanical Pressure at Different Intensities

May 11, 2023 updated by: Josue Fernandez Carnero

Conditioned Pain Modulation Induced by Mechanical Stimulation. A Mechanism of Manual Therapy Analgesia: Study 2

The objective is to estimate the effects on pain thresholds of a painful mechanical stimulus on the upper trapezius at moderate intensity compared to mild intensity or non-painful.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Madrid
      • Alcorcón, Madrid, Spain, 28047
        • Universidad Rey Juan Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mechanical stimulation at moderate pain intensity
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.
Mechanical stimulus on the upper trapezius of the non-dominant side.
Active Comparator: Mechanical stimulation at mild pain intensity
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 carried out for 2 minutes.
Mechanical stimulus on the upper trapezius of the non-dominant side.
Active Comparator: Painless 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 0/10 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.
Mechanical stimulus on the upper trapezius of the non-dominant side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Tibialis Anterior Pressure Pain Threshold (PPT) to immediate post-conditioning stimulus
Time Frame: 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.
At baseline and immediately after the conditioning stimulus

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2023

Primary Completion (Actual)

April 17, 2023

Study Completion (Actual)

April 21, 2023

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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