Pain Inhibitory Effects of Other Pain Induced by Mechanical Pressure Compared to Electrical Stimulation and Cold Water.
Conditioned Pain Modulation Induced by Mechanical Stimulation: A Mechanism of Manual Therapy Analgesia - Study 1
1 other identifier
interventional
24
1 country
1
Brief Summary
The objective is to estimate the effects on pain thresholds of a painful mechanical stimulus on the upper trapezius compared to a painful electrical stimulus and a diffuse noxious stimulus using the cold water hand immersion test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Feb 2023
Shorter than P25 for not_applicable healthy
1 active site
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
CompletedFirst Posted
Study publicly available on registry
February 15, 2023
CompletedStudy Start
First participant enrolled
February 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 21, 2023
CompletedMay 12, 2023
May 1, 2023
2 months
February 6, 2023
May 11, 2023
Conditions
Keywords
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 pressure stimulation
EXPERIMENTALMechanical 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.
Electrical stimulation
ACTIVE COMPARATORTo perform this procedure a TENS will be used applying a biphasic current, since it is the most used and studied type of electrotherapy. A frequency of 100hz and a bandwidth of 150 will be used. The intensity will be increased and decreased with the patient's feeback in order to provoke a pain of approximately 5/10 in the NPRS. The stimulation will be performed for 2 minutes on the upper trapezius of the non-dominant side at the midpoint between acromion and C7.
Cold pressor task
ACTIVE COMPARATORThe non-dominant hand shall be placed in a bucket of cold water at 10.5° for 2 minutes.
Interventions
Pain stimulus on non-dominant side
Eligibility Criteria
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
Study Officials
- PRINCIPAL INVESTIGATOR
Josué Fernández Carnero, PhD
Universidad Rey Juan Carlos
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
Data Sharing
- IPD Sharing
- Will not share