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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Spain1 site
  • INEFCatalunya

    Barcelona, Barcelona, 08038

Other trials in Spain

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
  1. 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.
  2. 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 groups in NCT02876705
Study groupRoleWhat they receive
Pain PatternsExperimentalIn 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.

  1. 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.

  1. First posted24 Aug 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

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)
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/

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.

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