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

Sponsor
John Paul II University of Applied Sciences in Biala Podlaska (Other)
Overall Status
Completed
CT.gov ID
NCT05206383
Collaborator
(none)
90
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3
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Positive message - placebo
  • Behavioral: Negative message - nocebo
  • Behavioral: Neutral message
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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 messageThe 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
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Influence of Oral Messages on the Activity of Wrist and Finger Flexor Muscles - in the Context of Application of Sham Therapy
Actual Study Start Date :
Dec 1, 2021
Actual Primary Completion Date :
Apr 30, 2022
Actual Study Completion Date :
Aug 8, 2022

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Dynamometer tests [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 Outcome Measures

  1. Testing with Naroxon Ultimum EMG [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 24 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pope John Paul II State School Of Higher Education in Biała Podlaska Biała Podlaska Poland 21-500

Sponsors and Collaborators

  • John Paul II University of Applied Sciences in Biala Podlaska

Investigators

  • Study Chair: Kamil Zaworski, FIZJOPERFEKT Kamil Zaworski

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kamil Zaworski, Director, John Paul II University of Applied Sciences in Biala Podlaska
ClinicalTrials.gov Identifier:
NCT05206383
Other Study ID Numbers:
  • PopeJohnPaulIIStateSchHigherE3
First Posted:
Jan 25, 2022
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kamil Zaworski, Director, John Paul II University of Applied Sciences in Biala Podlaska

Study Results

No Results Posted as of Aug 10, 2022