NCT05206383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2022

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

December 28, 2021

Last Update Submit

August 8, 2022

Conditions

Keywords

muscle powermuscle activitysham therapyoral message

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (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.

Study Arms (3)

Positive message

EXPERIMENTAL

Group A - 30 subjects who will be told that positive message.

Behavioral: Positive message - placebo

Negative message

EXPERIMENTAL

Group B - 30 subjects who will be told negative message.

Behavioral: Negative message - nocebo

Neutral message

EXPERIMENTAL

Group C - 30 people who will be told neutral message.

Behavioral: Neutral message

Interventions

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

Positive message

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

Negative message
Neutral messageBEHAVIORAL

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

Neutral message

Eligibility Criteria

Age19 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Biała Podlaska, 21-500, Poland

Location

MeSH Terms

Conditions

CommunicationMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Kamil Zaworski

    FIZJOPERFEKT Kamil Zaworski

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double (Participant, Outcomes Assessor)
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 28, 2021

First Posted

January 25, 2022

Study Start

December 1, 2021

Primary Completion

April 30, 2022

Study Completion

August 8, 2022

Last Updated

August 10, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations