- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06082752
The Analysis of the Impact of 5-minute Massage Session on the Muscle Stiffness and Tone
November 6, 2023 updated by: Krzysztof Kassolik, Phd, Wroclaw University of Health and Sport Sciences
The Analysis of the Impact of 5-minute Massage Session on the Muscle Stiffness and Tone: a Randomised Control Trial
The study design was a randomised, controlled, parallel, two-arm trial.
The subjects were randomly assigned to one of the study groups: the intervention group or the control group.
The passive mechanical properties, i.e. the stiffness and tone of the medial and lateral gastrocnemius muscle (dominant leg) were assessed.
Measures were taken twice: in the intervention group before and after the 5-minute massage session, and in the control group at the beginning of the meeting and again after 5 minutes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study was to determine whether a 5-minute massage, applied to healthy individuals, may change the passive mechanical muscle properties, which supposedly may prevent MSDs.
The study is carried out on the medial and lateral gastrocnemius muscles because of their accessibility and crucial role in locomotion.
MyotonPRO and TMG S2 devices were used to assess the stiffness and radial muscle displacement of the gastrocnemius muscle respectively.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Krzysztof Kassolik, PhD
- Phone Number: +48 504 549 427
- Email: p665569523@gmail.com
Study Contact Backup
- Name: Marcin Piwecki
- Phone Number: +48 665 569 523
- Email: p665569523@gmail.com
Study Locations
-
-
-
Wrocław, Poland
- Wroclaw University of Health and Sport Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- age between 19 and 24 years;
- healthy individuals, with no lower limb pathology;
- PA≥600 MET-min/week assessed by IPAQ questionnaire;
- no medical contraindication of massage therapy;
- body mass index 18,5 < BMI ≤ 25kg/m2
- signing the informed consent.
Exclusion Criteria:
- pregnant women;
- individuals suffering from neurologic or orthopaedic problems;
- lower limb surgical interventions;
- cancers;
- musculoskeletal disorders
- body mass index 18,5 > BMI ≥ 25kg/m2
- the lack of informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Massage group
In the intervention group measures will be taken twice: before and after the 5-minute massage session.
|
Participants in the intervention group are provided with the 5-minute massage session in the medial and lateral gastrocnemius muscle (dominant leg).
|
No Intervention: Non-massage group
In the control group measures will be taken twice: at the beginning of the meeting and again after 5 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in maximal displacement of the medial and lateral gastrocnemius muscle
Time Frame: 1) baseline, 2) immediately after the massage session
|
The maximal radial displacement is produced in the muscle belly after the electrical stimulation.
Measuring device: TMG S2
|
1) baseline, 2) immediately after the massage session
|
Changes in delay time of the medial and lateral gastrocnemius muscle
Time Frame: 1) baseline, 2) immediately after the massage session
|
Delay time is the time in which the muscle displacement increases to 10% after the electrical stimulation.
Measuring device: TMG S2
|
1) baseline, 2) immediately after the massage session
|
Changes in contraction time of the medial and lateral gastrocnemius muscle
Time Frame: 1) baseline, 2) immediately after the massage session
|
Contraction time is the time between 10% and 90% of the muscle displacement after the electrical stimulation.
Measuring device: TMG S2
|
1) baseline, 2) immediately after the massage session
|
Changes in sustain time of the medial and lateral gastrocnemius muscle
Time Frame: 1) baseline, 2) immediately after the massage session
|
Sustain time is the time between 50% of maximum contraction to 50% of maximum relaxation of a muscle after the electrical stimulation.
Measuring device: TMG S2
|
1) baseline, 2) immediately after the massage session
|
Changes in relaxation time of the medial and lateral gastrocnemius muscle
Time Frame: 1) baseline, 2) immediately after the massage session
|
Relaxation time is the time between 90% of maximum contraction and 50% of maximum relaxation of a muscle after the electrical stimulation.
Measuring device: TMG S2
|
1) baseline, 2) immediately after the massage session
|
Changes in oscillation frequency of the medial and lateral gastrocnemius muscle
Time Frame: 1) baseline, 2) immediately after the massage session
|
The oscillation frequency characterizes the tension of muscle tissue.
Measuring device: MyotonPRO
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1) baseline, 2) immediately after the massage session
|
Changes in dynamic stiffness of the medial and lateral gastrocnemius muscle
Time Frame: 1) baseline, 2) immediately after the massage session
|
The dynamic stiffness corresponds to the soft tissues' capacity to resist external forces.
Measuring device: MyotonPRO
|
1) baseline, 2) immediately after the massage session
|
Changes in logarithmic decrement of the medial and lateral gastrocnemius muscle
Time Frame: 1) baseline, 2) immediately after the massage session
|
Logarithmic decrement is the dissipation of the tissue oscillation.
Measuring device: MyotonPRO
|
1) baseline, 2) immediately after the massage session
|
Changes in mechanical stress relaxation time of the medial and lateral gastrocnemius muscle
Time Frame: 1) baseline, 2) immediately after the massage session
|
Mechanical stress relaxation time is the time needed for the muscle to recover to its initial shape.
Measuring device: MyotonPRO
|
1) baseline, 2) immediately after the massage session
|
Changes in creep of the medial and lateral gastrocnemius muscle
Time Frame: 1) baseline, 2) immediately after the massage session
|
Creep is the ratio of relaxation (R) and time between the beginning of the mechanical impulse and the time point of maximal displacement Measuring device: MyotonPRO
|
1) baseline, 2) immediately after the massage session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Krzysztof Kassolik, Wroclaw University of Health and Sport Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2023
Primary Completion (Actual)
November 5, 2023
Study Completion (Actual)
November 6, 2023
Study Registration Dates
First Submitted
October 7, 2023
First Submitted That Met QC Criteria
October 7, 2023
First Posted (Actual)
October 13, 2023
Study Record Updates
Last Update Posted (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 6, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WroclawUHSS
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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