Clinical trial NCT05206383: Influence of Oral Messages on the Activity of Wrist and Finger Flexor Muscles
Official title: Influence of Oral Messages on the Activity of Wrist and Finger Flexor Muscles - in the Context of Application of Sham Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle
Communication
Activity, Motor
Keywords: muscle power
muscle activity
sham therapy
oral message
Lead sponsor: John Paul II University in Biała Podlaska
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study participants will be randomly qualified (allocated via a computer program) to the tree groups: A - positive message - placebo, B - negative message - nocebo, C - neutral message
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dynamometer tests
timeFrame: Change in measured parameters 10 minutes after application of the plaster and delivery of the oral message relative to baseline measurement.
Secondary outcomes:
measure: Testing with Naroxon Ultimum EMG
timeFrame: Change in measured parameters 10 minutes after application of the plaster and delivery of the oral message relative to baseline measurement.
Other outcomes:
Locations:
city: Biała Podlaska
country: Poland
facility: Pope John Paul II State School Of Higher Education in Biała Podlaska
Study officials:
affiliation: FIZJOPERFEKT Kamil Zaworski
name: Kamil Zaworski
role: STUDY_CHAIR
References: