Endogenous Modulation of Pain and Stretch Tolerance

March 22, 2019 updated by: University College of Northern Denmark

Endogenous Modulation of Pain - the Tolerance to Stretch

This study investigates the role of two endogenous inhibitory mechanisms; exercise-induced hypoalgesia (EIH) and a conditioning painful stimulus (CPM) on passive joint range of motion, passive resistive torque and pain sensitivity. The study is a randomized, repeated-measures cross-over study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The increase in range of motion following stretching is related to changes in the tolerance to stretch. The mechanistic relationships behind these changes in subject sensation are however unknown but could be related to endogenous modulation of pain.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Denmark
      • Aalborg, Denmark, 9220
        • University College of Northern Denmark

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Eligibility for participation included the absence of any pain or other conditions that might affect the somatosensory system.

Exclusion Criteria:

  • Substance abuse, History of neurological or mental disabilities, Lack of ability to comply with instructions, Delayed onset of muscle soreness.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise-induced hypoalgesia (EIH)
Exercise-induced hypoalgesia - isometric muscle contractions of the hand flexors
Other: Exercise induced hypoalgesia (EIH)
An EIH response was induced by a 3-minute isometric contraction of the hand flexor muscles at 25% of maximal voluntary contraction (MVC).
Active Comparator: Static stretch (SS)
A static stretch of the knee flexors
Other: Static stretch (SS)
Two bouts of 30 seconds of static stretching (SS) of the knee flexors.
Sham Comparator: Rest
No intervention
Other: Rest
The participants rested in a seated position for 10 minutes
Experimental: Conditioning painful stimulus (CPM)
Conditioned pain modulation - cold pressure test
Other: Conditioned pain modulation (CPM)
A CPM response was induced by way of the cold pressor test.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Knee extension range of motion
Time Frame: Passive knee extension range of motion was measured as a baseline just prior to the induction of exercise-induced hypoalgesia (EIH), Static stretch (SS), Rest and a conditioning painful stimulus (CPM)
Passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynamometer
Passive knee extension range of motion was measured as a baseline just prior to the induction of exercise-induced hypoalgesia (EIH), Static stretch (SS), Rest and a conditioning painful stimulus (CPM)
Knee extension range of motion
Time Frame: Passive knee extension range of motion was measured 30 seconds after the induction of EIH, SS, Rest and CPM
Passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynamometer
Passive knee extension range of motion was measured 30 seconds after the induction of EIH, SS, Rest and CPM
Knee extension range of motion
Time Frame: Passive knee extension range of motion was measured 10 minutes after the induction of EIH, SS, Rest and CPM
Passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynamometer
Passive knee extension range of motion was measured 10 minutes after the induction of EIH, SS, Rest and CPM

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Passive resistive torque
Time Frame: Passive resistive torque was measured as a baseline just prior to the induction of EIH, SS, Rest and CPM
Passive resistive torque during the passive knee extension motion was measured using the Biodex system 4 pro isokinetic dynamometer.
Passive resistive torque was measured as a baseline just prior to the induction of EIH, SS, Rest and CPM
Passive resistive torque
Time Frame: Passive resistive torque was measured 30 seconds after the induction of EIH, SS, Rest and CPM
Passive resistive torque during the passive knee extension motion was measured using the Biodex system 4 pro isokinetic dynamometer.
Passive resistive torque was measured 30 seconds after the induction of EIH, SS, Rest and CPM
Passive resistive torque
Time Frame: Passive resistive torque was measured 10 minutes after the induction of EIH, SS, Rest and CPM
Passive resistive torque during the passive knee extension motion was measured using the Biodex system 4 pro isokinetic dynamometer.
Passive resistive torque was measured 10 minutes after the induction of EIH, SS, Rest and CPM
Pressure pain thresholds
Time Frame: Pressure pain thresholds were measured as a baseline just prior to the induction of EIH, SS, Rest and CPM
Pressure pain thresholds was measures using a handheld pressure algometer (Somedic AB, Hörby, Sweden.
Pressure pain thresholds were measured as a baseline just prior to the induction of EIH, SS, Rest and CPM
Pressure pain thresholds
Time Frame: Pressure pain thresholds were measured 30 seconds after the induction of EIH, SS, Rest and CPM
Pressure pain thresholds was measures using a handheld pressure algometer (Somedic AB, Hörby, Sweden.
Pressure pain thresholds were measured 30 seconds after the induction of EIH, SS, Rest and CPM
Pressure pain thresholds
Time Frame: Pressure pain thresholds were measured 10 minutes after the induction of EIH, SS, Rest and CPM
PRessure pain thresholds was measures using a handheld pressure algometer (Somedic AB, Hörby, Sweden.
Pressure pain thresholds were measured 10 minutes after the induction of EIH, SS, Rest and CPM

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University College of Northern Denmark

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Dorte Drachman, Msc., University College of Northern Denmark, Department of Physiotherapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UniversityCND1

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings