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Influence of Oral Messages on the Activity of Wrist and Finger Flexor Muscles

8. august 2022 opdateret af: Kamil Zaworski, John Paul II University of Applied Sciences in Biala Podlaska

Influence of Oral Messages on the Activity of Wrist and Finger Flexor Muscles - in the Context of Application of Sham Therapy

The aim of the study will be to evaluate the effect of oral messages on wrist and finger flexor muscle activity during the application of sham therapy in the form of paper plaster.

For years, research has been conducted on the effects of dynamic plaster and rigid plaster on muscle function. In many cases, reports from different authors are contradictory. Therefore, the planned study will use placebo paper plaster with no proven therapeutic effect.

Studieoversigt

Detaljeret beskrivelse

People's words can have a huge impact on how we interpret our surroundings, what we expect and experience, and how we behave. The placebo (and nocebo) effects are a clear example here. The way health professionals discuss, describe and inform patients about the characteristic effects of a given disease, its prevention, diagnosis and treatment influences patients' feelings and expectations, which in turn affects their psychobiological responses, subjective feelings and treatment outcomes.

The right choice of words by clinicians influences patients' response to medical treatments and procedures, both active and sham. The way in which information about the effects of treatment is communicated to patients can reinforce the outcomes of a particular treatment (placebo) or reverse clinically-proven effects of an active treatment, or even increase its adverse effects. The right messages can reduce the nocebo effect. And vice versa, the wrong choice of information provided may increase the patient's anxiety and disease symptoms.

The aim of the study will be to evaluate the effect of oral messages on wrist and finger flexor muscle activity during the application of sham therapy in the form of paper plaster.

Main hypothesis:

The use of a positive message will have an effect on increasing the activation and strength of the flexor muscles of the wrist joint and fingers.

Research questions:

  1. Does a positive message have an effect on increasing the activation and strength of the flexor muscles of the wrist joint and fingers?
  2. Does a negative message have an effect on increasing the activation and strength of the flexor muscles of the wrist joint and fingers? Does a neutral message have an effect on increasing the activation and strength of the flexor muscles of the wrist joint and fingers?

The study will be a prospective, flow-up study using a differential variable in the form of the type of message used (positive - placebo, negative - nocebo, neutral). The respondents will be randomly allocated to study groups using sealed allocation sheets.

Before taking part in the study, each subject will be familiarised with the course of the study and must give written informed consent to participate in the study and to be randomly assigned to a specific study group.

The subjects will be assessed twice - before applying a paper plaster and 10 minutes after applying the plaster and delivering a voice message.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Biała Podlaska, Polen, 21-500
        • Pope John Paul II State School Of Higher Education in Biała Podlaska

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

19 år til 24 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • subjects not using non-steroidal anti-inflammatory drugs (NSAIDs) for at least one week prior to study entry,
  • age - 19-24 years,
  • written consent to participate in the study.

Exclusion Criteria:

  • subjects studying for a degree in physiotherapy,
  • subjects post surgery on the examined upper limb,
  • subjects with past bone fractures in the examined upper limb,
  • subjects who have had an injury to the examined upper limb within 6 months before the start of the study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Positive message
Group A - 30 subjects who will be told that positive message.
Subjects who will be told that "the applied plastering method significantly increases muscle strength" (positive message - placebo).
Eksperimentel: Negative message
Group B - 30 subjects who will be told negative message.
Subjects who will be told that "the applied plastering method has no effect on muscle strength" (negative message - nocebo).
Eksperimentel: Neutral message
Group C - 30 people who will be told neutral message.
Subjects who will be told that "the applied plastering method is currently under investigation and the investigators do not know its effects" (neutral message).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dynamometer tests
Tidsramme: Change in measured parameters 10 minutes after application of the plaster and delivery of the oral message relative to baseline measurement.
Assessment of wrist and finger flexor muscle strength. Patient in sitting position with the elbow joint on the examined side bent and the forearm resting on the table. The patient squeezes the dynamometer for a period of 3-5 seconds.
Change in measured parameters 10 minutes after application of the plaster and delivery of the oral message relative to baseline measurement.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Testing with Naroxon Ultimum EMG
Tidsramme: Change in measured parameters 10 minutes after application of the plaster and delivery of the oral message relative to baseline measurement.

Assessment of wrist and finger flexor muscle activity. Patient in sitting position with the elbow joint on the examined side bent and the forearm resting on the table. The subject's arm is adducted, the wrist joint in an intermediate position. The electrodes are glued in the belly area of the flexor muscles of the wrist and fingers - about 2 cm from the medial epicondyle of the humerus in a distal direction at a distance of 1 cm from each other.

The patient squeezes the dynamometer for a period of 3-5 seconds.

Change in measured parameters 10 minutes after application of the plaster and delivery of the oral message relative to baseline measurement.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studiestol: Kamil Zaworski, FIZJOPERFEKT Kamil Zaworski

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2021

Primær færdiggørelse (Faktiske)

30. april 2022

Studieafslutning (Faktiske)

8. august 2022

Datoer for studieregistrering

Først indsendt

28. december 2021

Først indsendt, der opfyldte QC-kriterier

11. januar 2022

Først opslået (Faktiske)

25. januar 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. august 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. august 2022

Sidst verificeret

1. august 2022

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • PopeJohnPaulIIStateSchHigherE3

Plan for individuelle deltagerdata (IPD)

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