- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05730127
Pain Inhibitory Effects of Other Pain Induced by Mechanical Pressure Compared to Electrical Stimulation and Cold Water.
May 11, 2023 updated by: Josue Fernandez Carnero
Conditioned Pain Modulation Induced by Mechanical Stimulation: A Mechanism of Manual Therapy Analgesia - Study 1
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.
Study Overview
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 pressure 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.
|
Pain stimulus on non-dominant side
|
Active Comparator: Electrical stimulation
To 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.
|
Pain stimulus on non-dominant side
|
Active Comparator: Cold pressor task
The non-dominant hand shall be placed in a bucket of cold water at 10.5° for 2 minutes.
|
Pain stimulus on 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.
Sponsor
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
Other Study ID Numbers
- MechCPM1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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