MuscleNCT05206383
Influence of Oral Messages on the Activity of Wrist and Finger Flexor Muscles
A study testing Negative message - nocebo and Neutral message in people with Muscle and Communication, run by John Paul II University in Biała Podlaska at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 19 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle, Communication, Activity, Motor
- What is being tested?
- Negative message - nocebo and Neutral message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2021to 8 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Pope John Paul II State School Of Higher Education in Biała Podlaska
Biała Podlaska, 21-500
About this study
Official title: 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.
Read the 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:
- Does a positive message have an effect on increasing the activation and strength of the flexor muscles of the wrist joint and fingers?
- 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.
- Conditions
- Muscle, Communication, Activity, Motor
- Being tested
- Positive message - placebo, Negative message - nocebo, Neutral message
- Keywords
- muscle power, muscle activity, sham therapy, oral message
- Medical subject headings
- Communication, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive message - placeboBehavioural
Subjects who will be told that "the applied plastering method significantly increases muscle strength" (positive message - placebo).
Negative message - noceboBehavioural
Subjects who will be told that "the applied plastering method has no effect on muscle strength" (negative message - nocebo).
Neutral messageBehavioural
Subjects who will be told that "the applied plastering method is currently under investigation and the investigators do not know its effects" (neutral message).
| Study group | Role | What they receive |
|---|---|---|
| Positive message | Experimental | Group A - 30 subjects who will be told that positive message. Receives: Behavioral: Positive message - placebo |
| Negative message | Experimental | Group B - 30 subjects who will be told negative message. Receives: Behavioral: Negative message - nocebo |
| Neutral message | Experimental | Group C - 30 people who will be told neutral message. Receives: Behavioral: Neutral message |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Change in measured parameters 10 minutes after application of the plaster and delivery of the oral message relative to baseline measurement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start1 Dec 2021
- Primary completion30 Apr 2022
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MuscleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Paul II University in Biała Podlaska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamil Zaworski, John Paul II University in Biała Podlaska
- Investigators
- Kamil Zaworski, Study chair, FIZJOPERFEKT Kamil Zaworski
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206383
- Sponsor's protocol ID
- PopeJohnPaulIIStateSchHigherE3
- Status last verified
- Aug 2022
- First submitted
- 28 Dec 2021
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Oral Messages on the Activity of Wrist and Finger Flexor Muscles - in the Context of Application of Sham Therapy
- ClinicalTrials.gov ID
- NCT05206383
- Acronym / sponsor ID
- PopeJohnPaulIIStateSchHigherE3
- Conditions
- Muscle, Communication, Activity, Motor
- Keywords
- muscle power, muscle activity, sham therapy, oral message
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- John Paul II University in Biała PodlaskaUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does a positive message have an effect on increasing the activation and strength of the flexor muscles of the wrist joint and fingers?
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Positive message | Experimental | Behavioral: Positive message - placeboGroup A - 30 subjects who will be told that positive message. |
| Negative message | Experimental | Behavioral: Negative message - noceboGroup B - 30 subjects who will be told negative message. |
| Neutral message | Experimental | Behavioral: Neutral messageGroup C - 30 people who will be told neutral message. |
Who may qualify
- Ages
- 19 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive message - placeboSubjects who will be told that "the applied plastering method significantly increases muscle strength" (positive message - placebo). | Behavioural | Positive message |
| Negative message - noceboSubjects who will be told that "the applied plastering method has no effect on muscle strength" (negative message - nocebo). | Behavioural | Negative message |
| Neutral messageSubjects who will be told that "the applied plastering method is currently under investigation and the investigators do not know its effects" (neutral message). | Behavioural | Neutral message |
Primary outcome
Dynamometer tests
Time frame: 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.
1 secondary outcome
Testing with Naroxon Ultimum EMG
Time frame: Change in measured parameters 10 minutes after application of the plaster and delivery of the oral message relative to baseline measurement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamil Zaworski study chair
FIZJOPERFEKT Kamil Zaworski
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative message - nocebo and Neutral message in people with Muscle and Communication, run by John Paul II University in Biała Podlaska at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamometer tests (time frame: Change in measured parameters 10 minutes after application of the plaster and delivery of the oral message relative to baseline measurement.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.