PainEarly Phase 1NCT02876705
Spatiotemporal Patterns of Pain During Exercise
A Early Phase 1 study testing Exercise in people with Pain, run by Institut Nacional d'Educacio Fisica de Catalunya at 1 site in Spain.
Trial summary
The purpose of this study will be to study the individual spatiotemporal structure and dynamics of topologically defined areas of perceived body discomfort and pain during exercise. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2016to Oct 2016
- Phase
- Early Phase 1
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants had no sport specialization but were engaged in a wide range of aerobic activities at least three times a week. Inclusion criterion for the study was the absence of chronic pain and injuries, and normal weight: BMI from 18.5 to 25.
Who cannot join
- Participants professionally specialized in sports and poorly active (<3 times a week) were excluded from the study. Exclusion was made also for the participants who suffered neuropathic and/or chronic pain. Underweighted and overweighed participants were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spatiotemporal Patterns of Pain and Discomfort During Exhausting Exercise
The purpose of this study will be to study the individual spatiotemporal structure and dynamics of topologically defined areas of perceived body discomfort and pain during exercise. Participants will perform two constant tests (cycling and running) at an intensity corresponding to Borg's scale of Rating of Perceived Exhaustion (RPE) (6-20) = 15 (i.e., hard). Using a body map template, participants will report every 15s the perceived locations with discomfort and pain independently of the magnitude of the discomfort and pain.
Read the detailed description
- Intro Pain recently was defined as distressing experience associated with actual or potential tissue damage with sensory, cognitive, emotional, and social components. Pain can be seen as perceptual marker within physical exercise. Individuals can report on a number of perceptual markers such as the changes in exertive pain which was shown to be a distinct source of information than reports of PE during cycling for instance. The perceptual markers of pain are still little investigated within exercise settings. From another side, to best understand exertive pain, one needs to consider several dimensions of pain including the sensory-discriminative, affective-motivational, and the cognitive-evaluative dimensions. Several number of studies within the exercise science have focused on the sensory-discriminative dimension of pain. Results from these have suggested a linear relationship between pain perception and the power output in diverse effort settings including cycling, static and dynamic handgrip squeezing, and incremental treadmill running. Indeed, the comparison of ratio of leg pain to arm pain during cycling and running has also demonstrated that the ratio of leg to arm pain increases across higher intensities. Most of the extant work however centred on pain and PE from a group-based standpoint to lead to group-based conclusions. Traditionally, within exercise science, variables are measured at distinct, low-frequency time points, and then are either averaged over the course of the trial or reported at the measured time. In turn, such practices make it difficult to measure dynamic feed-forward and feedback control mechanisms inherent in these variables. Taken these together, studying pain and discomfort from an individual, case-by-case standpoint, in a high-frequency time points setting, may present unique benefits. Considering that the physiological and psychological variables (e.g., PE) present fluctuations during heavy constant-power cycling when reporting at a measurement frequency of 15s it seems plausible to assume that pain locations can also fluctuate. Consequently, it may be useful to distinguish amongst differential types of spatiotemporal pain fluctuations patterns during exercise. Mapping these dynamics can help predict individual-specific fatigue in the course of exercise. The functional role of fluctuating dynamics has already been studied in psychological (e.g., volitional states, thought processes) and kinematic variables during constant-power exercise performed until volitional exhaustion. These approaches are important in that the suppression of the intra- individual variability performed by a statistical averaging may hide the properties of individual systems. In this vein, we tend to study and delineate individualized pain and discomfort patterns in exercise. The purpose of this study will be to study the individual spatiotemporal structure and dynamics of topologically defined areas of perceived body discomfort and pain during exercise.
- Methods 2.1 Participants To determine the sample size for this study a power analysis was conducted using G*Power 3.1. In studies of thought processes larger effect sizes have been reported. Thus, using an effect size of d = 1.0, α < 0.05, power (1 - β) = 0.80, a sample size of n = 11 emerged. Caucasian physical education students (age range: 18 - 30 years) undergoing regular aerobic exercise will be recruited to participate voluntarily in the study. Students will receive oral and written information regarding the study. They will be additionally encouraged to ask questions if there would still any ambiguities.
2.2 Materials and procedure Completion of this study will took a total of three sessions, separated by one-week intervals, and each of approximately 30 minutes. At week one, participants will complete a baseline incremental cycling and running tests to determine the workload and velocity values corresponding to their RPE (6-20 Borg's scale) = 15 (i.e., heavy). At this time, participants also will be familiarized with the use of body maps and reporting procedures. At week two and three, participants will complete the constant-power cycling and constant velocity running tasks, respectively, in a counter-balanced assigned order.
2.2.1. Monitoring for Discomfort and Pain Every 15s during exercise, upon the researcher's prompts, participants will report bodily locations with discomfort and pain on a body map scale.
2.2.2. Constant-power Cycling Task The task will include an incremental warm-up session and a constant-power cycling which will be performed up to volitional exhaustion. The constant-power cycling will begin when participants will report RPE = 15 during the incremental warm-up and the cycling task will last up to volitional exhaustion. The end will be set when participants won't be able to cycle longer at the fixed cadence for five consecutive seconds at the sitting position.
2.2.3. Constant-velocity Running Task The task will include an incremental warm-up (identical to the running baseline test) and a constant velocity run which will be performed up to volitional exhaustion. The constant velocity run will start when participants will achieve and report RPE = 15 during the incremental warm-up and will last up to volitional exhaustion when they could no longer be able to maintain the imposed velocity.
2.2.4. Commitment check Upon the completion of all testing procedures participants will answer questions about complete commitment to measure their commitment levels to the reporting tasks (a) and commitment to task (b), on an 11-point Likert-type scale with anchors ranging from 0 (not at all) to 10 (greatly).
2.3 Data collection and analysis All the locations for each participant will be transformed to binary vectors. Investigators will analyse the effects of the time steps using repeated measures ANOVAs. Principal component analysis (PCA) will be used to reduce the dimensionality of the local discomfort and/or pain data (that will be obtained from the 50-item pain map). The data and time of each testing session will be reported in a list. All data can be reconstructed for each participants.
- Conditions
- Pain
- Being tested
- Exercise
- Keywords
- Patterns, Pain, Cycling, Running, Exhaustion
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Completion of this study will took a total of three sessions, separated by one-week intervals. At week one, participants will complete a baseline incremental cycling and running tests to determine the workload and velocity values corresponding to their RPE (6-20 Borg's scale) = 15 (i.e., heavy). Participants also will be familiarized with the use of body maps and reporting procedures. At week two and three, participants will complete the constant-power cycling and constant velocity running tasks. The constant-power cycling and running will last up to volitional exhaustion. The end will be set when participants won't be able to cycle longer at the fixed cadence.
| Study group | Role | What they receive |
|---|---|---|
| Pain Patterns | Experimental | In this vein, we tend to study and delineate individualized pain and discomfort patterns in exercise. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of pain location during exercise measured through pain drawings, body maps, or manikins.
We tend to study and delineate individualized pain and discomfort patterns during exercise.
Measured: through study completion, an average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Nacional d'Educacio Fisica de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agne Slapsinskaite, Institut Nacional d'Educacio Fisica de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876705
- Sponsor's protocol ID
- INEFC-Psychobiological
- Status last verified
- Oct 2016
- First submitted
- 5 Aug 2016
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 25th of October 2016, all files will be available from the database https://figshare.com/
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatiotemporal Patterns of Pain and Discomfort During Exhausting Exercise
- ClinicalTrials.gov ID
- NCT02876705
- Acronym / sponsor ID
- INEFC-Psychobiological
- Conditions
- Pain
- Keywords
- Patterns, Pain, Cycling, Running, Exhaustion
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Institut Nacional d'Educacio Fisica de CatalunyaUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 24 Aug 2016 (estimated)
- 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 purpose of this study will be to study the individual spatiotemporal structure and dynamics of topologically defined areas of perceived body discomfort and pain during exercise. Participants will perform two constant tests (cycling and running) at an intensity corresponding to Borg's scale of Rating of Perceived Exhaustion (RPE) (6-20) = 15 (i.e., hard). Using a body map template, participants will report every 15s the perceived locations with discomfort and pain independently of the magnitude of the discomfort and pain.
Detailed description
- Intro Pain recently was defined as distressing experience associated with actual or potential tissue damage with sensory, cognitive, emotional, and social components. Pain can be seen as perceptual marker within physical exercise. Individuals can report on a number of perceptual markers such as the changes in exertive pain which was shown to be a distinct source of information than reports of PE during cycling for instance. The perceptual markers of pain are still little investigated within exercise settings. From another side, to best understand exertive pain, one needs to consider several dimensions of pain including the sensory-discriminative, affective-motivational, and the cognitive-evaluative dimensions. Several number of studies within the exercise science have focused on the sensory-discriminative dimension of pain. Results from these have suggested a linear relationship between pain perception and the power output in diverse effort settings including cycling, static and dynamic handgrip squeezing, and incremental treadmill running. Indeed, the comparison of ratio of leg pain to arm pain during cycling and running has also demonstrated that the ratio of leg to arm pain increases across higher intensities. Most of the extant work however centred on pain and PE from a group-based standpoint to lead to group-based conclusions. Traditionally, within exercise science, variables are measured at distinct, low-frequency time points, and then are either averaged over the course of the trial or reported at the measured time. In turn, such practices make it difficult to measure dynamic feed-forward and feedback control mechanisms inherent in these variables. Taken these together, studying pain and discomfort from an individual, case-by-case standpoint, in a high-frequency time points setting, may present unique benefits. Considering that the physiological and psychological variables (e.g., PE) present fluctuations during heavy constant-power cycling when reporting at a measurement frequency of 15s it seems plausible to assume that pain locations can also fluctuate. Consequently, it may be useful to distinguish amongst differential types of spatiotemporal pain fluctuations patterns during exercise. Mapping these dynamics can help predict individual-specific fatigue in the course of exercise. The functional role of fluctuating dynamics has already been studied in psychological (e.g., volitional states, thought processes) and kinematic variables during constant-power exercise performed until volitional exhaustion. These approaches are important in that the suppression of the intra- individual variability performed by a statistical averaging may hide the properties of individual systems. In this vein, we tend to study and delineate individualized pain and discomfort patterns in exercise. The purpose of this study will be to study the individual spatiotemporal structure and dynamics of topologically defined areas of perceived body discomfort and pain during exercise.
- Methods 2.1 Participants To determine the sample size for this study a power analysis was conducted using G*Power 3.1. In studies of thought processes larger effect sizes have been reported. Thus, using an effect size of d = 1.0, α < 0.05, power (1 - β) = 0.80, a sample size of n = 11 emerged. Caucasian physical education students (age range: 18 - 30 years) undergoing regular aerobic exercise will be recruited to participate voluntarily in the study. Students will receive oral and written information regarding the study. They will be additionally encouraged to ask questions if there would still any ambiguities.
2.2 Materials and procedure Completion of this study will took a total of three sessions, separated by one-week intervals, and each of approximately 30 minutes. At week one, participants will complete a baseline incremental cycling and running tests to determine the workload and velocity values corresponding to their RPE (6-20 Borg's scale) = 15 (i.e., heavy). At this time, participants also will be familiarized with the use of body maps and reporting procedures. At week two and three, participants will complete the constant-power cycling and constant velocity running tasks, respectively, in a counter-balanced assigned order.
2.2.1. Monitoring for Discomfort and Pain Every 15s during exercise, upon the researcher's prompts, participants will report bodily locations with discomfort and pain on a body map scale.
2.2.2. Constant-power Cycling Task The task will include an incremental warm-up session and a constant-power cycling which will be performed up to volitional exhaustion. The constant-power cycling will begin when participants will report RPE = 15 during the incremental warm-up and the cycling task will last up to volitional exhaustion. The end will be set when participants won't be able to cycle longer at the fixed cadence for five consecutive seconds at the sitting position.
2.2.3. Constant-velocity Running Task The task will include an incremental warm-up (identical to the running baseline test) and a constant velocity run which will be performed up to volitional exhaustion. The constant velocity run will start when participants will achieve and report RPE = 15 during the incremental warm-up and will last up to volitional exhaustion when they could no longer be able to maintain the imposed velocity.
2.2.4. Commitment check Upon the completion of all testing procedures participants will answer questions about complete commitment to measure their commitment levels to the reporting tasks (a) and commitment to task (b), on an 11-point Likert-type scale with anchors ranging from 0 (not at all) to 10 (greatly).
2.3 Data collection and analysis All the locations for each participant will be transformed to binary vectors. Investigators will analyse the effects of the time steps using repeated measures ANOVAs. Principal component analysis (PCA) will be used to reduce the dimensionality of the local discomfort and/or pain data (that will be obtained from the 50-item pain map). The data and time of each testing session will be reported in a list. All data can be reconstructed for each participants.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain Patterns | Experimental | Other: ExerciseIn this vein, we tend to study and delineate individualized pain and discomfort patterns in exercise. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants had no sport specialization but were engaged in a wide range of aerobic activities at least three times a week. Inclusion criterion for the study was the absence of chronic pain and injuries, and normal weight: BMI from 18.5 to 25.
Key exclusion criteria (1 listed)
- Participants professionally specialized in sports and poorly active (<3 times a week) were excluded from the study. Exclusion was made also for the participants who suffered neuropathic and/or chronic pain. Underweighted and overweighed participants were excluded.
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 |
|---|---|---|
| ExerciseCompletion of this study will took a total of three sessions, separated by one-week intervals. At week one, participants will complete a baseline incremental cycling and running tests to determine the workload and velocity values corresponding to their RPE (6-20 Borg's scale) = 15 (i.e., heavy). Participants also will be familiarized with the use of body maps and reporting procedures. At week two and three, participants will complete the constant-power cycling and constant velocity running tasks. The constant-power cycling and running will last up to volitional exhaustion. The end will be set when participants won't be able to cycle longer at the fixed cadence. | Other | Pain Patterns |
Primary outcome
Changes of pain location during exercise measured through pain drawings, body maps, or manikins.
Time frame: through study completion, an average of 3 weeks
We tend to study and delineate individualized pain and discomfort patterns during exercise.
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 11 Oct 2016.
- Individual participant dataSharing planned: Yes. 25th of October 2016, all files will be available from the database https://figshare.com/
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Exercise in people with Pain, run by Institut Nacional d'Educacio Fisica de Catalunya 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 1 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 11 Oct 2016. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes of pain location during exercise measured through pain drawings, body maps, or manikins. (time frame: through study completion, an average of 3 weeks). 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 11 Oct 2016.