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

NCT05730179 | Completed

• 1 other identifier: MechCPM3
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Conditioned Pain Modulation; Manual Therapy; Physiotherapy; Physical therapy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Tibialis Anterior Pressure Pain Threshold (PPT) to immediate post-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

Study Arms (3)

Mechanical stimulation

ACTIVE COMPARATOR

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

Repeated mechanical stimulation

ACTIVE COMPARATOR

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

Repeated mechanical stimulation at different locations

ACTIVE COMPARATOR

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

Interventions

Mechanical Conditioning stimulus OTHER

Painful mechanical stimulus

Mechanical stimulation; Repeated mechanical stimulation; Repeated mechanical stimulation at different locations

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant or having given birth within the last year

Sponsors & Collaborators

• Josue Fernandez Carnero: lead

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28047, Spain

Location

Study Officials

• Josué Fernández Carnero, PhD

  Universidad Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: February 15, 2023
• Primary Completion: April 17, 2023
• Study Completion: April 21, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

ES (1)