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

Communication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05206383
• Other study ID #: PopeJohnPaulIIStateSchHigherE3
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: August 8, 2022

Study information

• Verified date: August 2022
• Source: John Paul II University of Applied Sciences in Biala Podlaska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 8, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Activity, Motor
• Communication
• Muscle

Intervention

Behavioral:
• Positive message - placebo
Subjects who will be told that "the applied plastering method significantly increases muscle strength" (positive message - placebo).
• Negative message - nocebo
Subjects who will be told that "the applied plastering method has no effect on muscle strength" (negative message - nocebo).
• 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).

Locations

Country	Name	City	State
Poland	Pope John Paul II State School Of Higher Education in Biala Podlaska	Biala Podlaska

Sponsors (1)

Lead Sponsor	Collaborator
John Paul II University of Applied Sciences in Biala Podlaska

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamometer tests	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.
Secondary	Testing with Naroxon Ultimum EMG	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.