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

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.

Study Overview

• Status: Completed
• Conditions: Communication; Activity, Motor; Muscle
• Intervention / Treatment: Behavioral: Positive message - placebo; Behavioral: Negative message - nocebo; Behavioral: Neutral message

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 24 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positive message; Group A - 30 subjects who will be told that positive message.	Behavioral: Positive message - placebo; Subjects who will be told that "the applied plastering method significantly increases muscle strength" (positive message - placebo).
Experimental: Negative message; Group B - 30 subjects who will be told negative message.	Behavioral: Negative message - nocebo; Subjects who will be told that "the applied plastering method has no effect on muscle strength" (negative message - nocebo).
Experimental: Neutral message; Group C - 30 people who will be told neutral message.	Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: John Paul II University of Applied Sciences in Biala Podlaska
• Investigators: Study Chair: Kamil Zaworski, FIZJOPERFEKT Kamil Zaworski

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): August 8, 2022

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: muscle activity; muscle power; sham therapy; oral message
• Other Study ID Numbers: PopeJohnPaulIIStateSchHigherE3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No