HealthyNCT05730127
Pain Inhibitory Effects of Other Pain Induced by Mechanical Pressure Compared to Electrical Stimulation and Cold Water.
A study testing Conditioning stimulus in people with Healthy, run by Josue Fernandez Carnero at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Conditioning stimulus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2023to 21 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy male or female between 18 and 65 years
- Free of pain and with no history of chronic pain
Who cannot join
- Pregnant or having given birth within the last year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Conditioning stimulus
- Keywords
- Conditioned Pain Modulation, Manual Therapy, Physiotherapy, Physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conditioning stimulusOther
Pain stimulus on non-dominant side
| Study group | Role | What they receive |
|---|---|---|
| Mechanical pressure stimulation | 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. Receives: Other: Conditioning stimulus |
| Electrical stimulation | Active comparator | 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. Receives: Other: Conditioning stimulus |
| Cold pressor task | Active comparator | The non-dominant hand shall be placed in a bucket of cold water at 10.5° for 2 minutes. Receives: Other: Conditioning stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and immediately after the conditioning stimulus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start15 Feb 2023
- Primary completion17 Apr 2023
- Study completion21 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Josue Fernandez Carnero
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
- Investigators
- Josué Fernández Carnero, PhD, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730127
- Sponsor's protocol ID
- MechCPM1
- Status last verified
- May 2023
- First submitted
- 6 Feb 2023
- Last updated
- 12 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conditioned Pain Modulation Induced by Mechanical Stimulation: A Mechanism of Manual Therapy Analgesia - Study 1
- ClinicalTrials.gov ID
- NCT05730127
- Acronym / sponsor ID
- MechCPM1
- Conditions
- Healthy
- Keywords
- Conditioned Pain Modulation, Manual Therapy, Physiotherapy, Physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Josue Fernandez CarneroUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mechanical pressure stimulation | Experimental | Other: Conditioning stimulusMechanical 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 comparator | Other: Conditioning stimulusTo 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 comparator | Other: Conditioning stimulusThe non-dominant hand shall be placed in a bucket of cold water at 10.5° for 2 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy male or female between 18 and 65 years
- Free of pain and with no history of chronic pain
Key exclusion criteria (1 listed)
- Pregnant or having given birth within the last year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conditioning stimulusPain stimulus on non-dominant side | Other | Cold pressor task, Electrical stimulation, Mechanical pressure stimulation |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josué Fernández Carnero, PhD principal investigator
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conditioning stimulus in people with Healthy, run by Josue Fernandez Carnero at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.