NCT05730166

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2023

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

February 6, 2023

Last Update Submit

May 11, 2023

Conditions

Healthy

Keywords

Conditioned Pain ModulationManual TherapyPhysiotherapyPhysical 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 at moderate pain intensity

EXPERIMENTAL

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

Mechanical stimulation at mild pain intensity

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 carried out for 2 minutes.

Other: Mechanical Conditioning stimulus

Painless 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 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.

Other: Mechanical Conditioning stimulus

Interventions

Mechanical Conditioning stimulusOTHER

Mechanical stimulus on the upper trapezius of the non-dominant side.

Mechanical stimulation at mild pain intensityMechanical stimulation at moderate pain intensityPainless mechanical stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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)