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Completed

NCT Number: NCT05206383

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

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.

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Key information

Age range

19 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pope John Paul II State School Of Higher Education in Biała Podlaska

Biała Podlaska, 21-500, Poland

About this study

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:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Positive message - placebo

Behavioral

Subjects who will be told that "the applied plastering method significantly increases muscle strength" (positive message - placebo).

Negative message - nocebo

Behavioral

Subjects who will be told that "the applied plastering method has no effect on muscle strength" (negative message - nocebo).

Neutral message

Behavioral

Subjects who will be told that "the applied plastering method is currently under investigation and the investigators do not know its effects" (neutral message).

Primary outcomes

  1. Dynamometer tests

    Time frame: 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.

Secondary outcomes

  1. Testing with Naroxon Ultimum EMG

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

John Paul II University in Biała Podlaska

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 25, 2022
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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