The Influence of Baseline Sensitivity and Expectation on Exercise-induced Hypoalgesia in Young Healthy Adults
11. mars 2019 oppdatert av: Marquette University
Quantitative Sensory Testing, Physical Activity, and Body Composition in Adults
The purpose of this study is to investigate the influence of baseline experimental pain sensitivity and expectation on the pain response following a single exercise session.
Pain assessment will be done with different intensities of noxious stimuli.
In addition, the expectation of how exercise impacts pain will be studied.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The relation between baseline pain sensitivity and the pain response following exercise is not clear.
The aims of this study are to investigate the influence of baseline experimental pain sensitivity on the pain response following submaximal isometric exercise, and whether expectations would influence outcomes with subsequent exposure to exercise.
Studietype
Intervensjonell
Registrering (Forventet)
250
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Marie Hoeger Bement, PT, PhD
- Telefonnummer: 414-288-6738
- E-post: mariehoeger.bement@marquette.edu
Studiesteder
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53201
- Rekruttering
- Marquette University
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Ta kontakt med:
- Marie Hoeger Bement, PT, PhD
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Healthy adults
- English proficiency
Exclusion Criteria:
- Acute pain condition
- Chronic pain condition
- Mental health disorder
- Cardiovascular disease
- Any chronic illness
- Difficulty with physical exercise
- Recent surgery
- Pulmonary disease
- Diabetes
- Smoking
- Raynaud disease
- Claustrophobia
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: submaximal isometric exercise.
submaximal isometric exercise will be performed.
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The exercise is a submaximal isometric contraction
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Ingen inngripen: Quiet rest.
Subject will rest in seating position for a period that mimics the exercise time.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The change from baseline of pain ratings during temporal summation of pressure pain assessment
Tidsramme: Before and immediately after exercise or quiet rest in session 1 and session 2 which will be on day 1 and day 7 of data collection.
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Temporal summation is the increase of pain over time caused by a constant or repetitive noxious stimulus.
Pain reports will be obtained during the application of constant mechanical stimulus with various intensities.
Subjects will be asked to rate the pain using a numerical pain rating scale that ranges from 0 (no pain) to 10 (worst pain).
Pain ratings will be obtained at the beginning, during, and at the end of the test while a noxious stimulus is applied to the index finger.
The change of pain ratings relative to baseline after exercise or quiet rest will be assessed.
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Before and immediately after exercise or quiet rest in session 1 and session 2 which will be on day 1 and day 7 of data collection.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Expectation
Tidsramme: Before exercise which will be on day 1 and day 7 of data collection.
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Subjects will be asked about their expectation of whether exercise will increase, decrease, or have no effect on the pain.
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Before exercise which will be on day 1 and day 7 of data collection.
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State version of the State-Trait Anxiety Inventory (STAI)
Tidsramme: After each temporal summation protocol in the first and second session which are on day 1 and day 7 of data collection.
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A 20-item questionnaire from state-trait anxiety inventory that evaluates different feelings the subject may or may not have at the moment.
The score of the questionnaire ranges from 0 to 80. Higher scores indicate greater state anxiety levels.
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After each temporal summation protocol in the first and second session which are on day 1 and day 7 of data collection.
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Trait version of the State-Trait Anxiety Inventory (STAI)
Tidsramme: Baseline (beginning of session 1) which is day 1 of the data collection.
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A 20-item questionnaire from state-trait anxiety inventory that evaluates how the subject feels in general and not restricted to the current moment.
The score of the questionnaire ranges from 0 to 80. Higher scores indicate greater trait anxiety levels.
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Baseline (beginning of session 1) which is day 1 of the data collection.
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Pain catastrophizing scale
Tidsramme: Baseline (beginning of session 1) which is day 1 of the data collection.
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A 13-item scale that evaluates if the subject has an exaggerated negative mental set towards pain.
It has 3 sub-scales which are magnification, rumination, and helplessness.
The scores of the sub-scales are summed to get the total score.
The total score ranges from 0 to 52.
Greater scores indicate greater catastrophizing thinking.
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Baseline (beginning of session 1) which is day 1 of the data collection.
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Situational pain catastrophizing scale
Tidsramme: After each temporal summation protocol in the first and second session which are day 1 and day 7 of data collection.
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A 6-item questionnaire that explores the negative mental set or catastrophizing thinking in reference to a particular experimental pain experience (i.e., temporal summation protocol).
The score ranges from 0 to 24 with higher scores indicating greater situational catastrophizing.
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After each temporal summation protocol in the first and second session which are day 1 and day 7 of data collection.
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Physical activity assessment using International physical activity questionnaire.
Tidsramme: Baseline (beginning of session 1 or 2) which is either day 1 or day 7 of data collection.
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International physical activity questionnaire (IPAQ) will be used to assess physical activity in the past week.
IPAQ evaluates physical activity not only related to leisure time but also related to other domains such as transportation, work, gardening or house related physical activities.
The questionnaire has been shown to be reliable and valid.
The time spent in moderate to vigorous physical activity (minutes/ week) from every domain will be summed with 0 indicating no time (minutes / week) spent moderate to vigorous activities and higher values indicate greater time spent in moderate to vigorous physical activity.
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Baseline (beginning of session 1 or 2) which is either day 1 or day 7 of data collection.
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Muscle mass assessment using Dual-energy x-ray absorptiometry.
Tidsramme: Baseline (in the first or second session) which is either day 1 or day 7 of data collection.
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Dual-energy x-ray absorptiometry (General Electric Healthcare, Madison, Wisconsin) is an x-ray scan that is used to assess muscle mass.
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Baseline (in the first or second session) which is either day 1 or day 7 of data collection.
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Fat mass assessment using Dual-energy x-ray absorptiometry.
Tidsramme: Baseline (in the first or second session) which is either day 1 or day 7 of data collection.
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Dual-energy x-ray absorptiometry (General Electric Healthcare, Madison, Wisconsin) is an x-ray scan that is used to assess fat mass.
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Baseline (in the first or second session) which is either day 1 or day 7 of data collection.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Marie Hoeger Bement, PT, PhD, Marquette University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
25. november 2017
Primær fullføring (Forventet)
30. desember 2022
Studiet fullført (Forventet)
30. desember 2022
Datoer for studieregistrering
Først innsendt
13. desember 2018
Først innsendt som oppfylte QC-kriteriene
11. mars 2019
Først lagt ut (Faktiske)
12. mars 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. mars 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. mars 2019
Sist bekreftet
1. mars 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- HR-2999
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