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The Analysis of the Impact of 5-minute Massage Session on the Muscle Stiffness and Tone

Primary Purpose

Musculoskeletal Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Massage session
Sponsored by
Wroclaw University of Health and Sport Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Musculoskeletal Disorder focused on measuring Massage therapy, Muscle tone, Muscle stiffness

Eligibility Criteria

19 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Wroclaw University of Health and Sport Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Massage group

Non-massage group

Arm Description

In the intervention group measures will be taken twice: before and after the 5-minute massage session.

In the control group measures will be taken twice: at the beginning of the meeting and again after 5 minutes.

Outcomes

Primary Outcome Measures

Changes in maximal displacement of the medial and lateral gastrocnemius muscle
The maximal radial displacement is produced in the muscle belly after the electrical stimulation. Measuring device: TMG S2
Changes in delay time of the medial and lateral gastrocnemius muscle
Delay time is the time in which the muscle displacement increases to 10% after the electrical stimulation. Measuring device: TMG S2
Changes in contraction time of the medial and lateral gastrocnemius muscle
Contraction time is the time between 10% and 90% of the muscle displacement after the electrical stimulation. Measuring device: TMG S2
Changes in sustain time of the medial and lateral gastrocnemius muscle
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
Changes in relaxation time of the medial and lateral gastrocnemius muscle
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
Changes in oscillation frequency of the medial and lateral gastrocnemius muscle
The oscillation frequency characterizes the tension of muscle tissue. Measuring device: MyotonPRO
Changes in dynamic stiffness of the medial and lateral gastrocnemius muscle
The dynamic stiffness corresponds to the soft tissues' capacity to resist external forces. Measuring device: MyotonPRO
Changes in logarithmic decrement of the medial and lateral gastrocnemius muscle
Logarithmic decrement is the dissipation of the tissue oscillation. Measuring device: MyotonPRO
Changes in mechanical stress relaxation time of the medial and lateral gastrocnemius muscle
Mechanical stress relaxation time is the time needed for the muscle to recover to its initial shape. Measuring device: MyotonPRO
Changes in creep of the medial and lateral gastrocnemius muscle
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

Secondary Outcome Measures

Full Information

First Posted
October 7, 2023
Last Updated
October 22, 2023
Sponsor
Wroclaw University of Health and Sport Sciences
Collaborators
University School of Physical Education, Krakow, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT06082752
Brief Title
The Analysis of the Impact of 5-minute Massage Session on the Muscle Stiffness and Tone
Official Title
The Analysis of the Impact of 5-minute Massage Session on the Muscle Stiffness and Tone: a Randomised Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 20, 2023 (Anticipated)
Primary Completion Date
November 5, 2023 (Anticipated)
Study Completion Date
November 7, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wroclaw University of Health and Sport Sciences
Collaborators
University School of Physical Education, Krakow, Poland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Disorder
Keywords
Massage therapy, Muscle tone, Muscle stiffness

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Massage group
Arm Type
Experimental
Arm Description
In the intervention group measures will be taken twice: before and after the 5-minute massage session.
Arm Title
Non-massage group
Arm Type
No Intervention
Arm Description
In the control group measures will be taken twice: at the beginning of the meeting and again after 5 minutes.
Intervention Type
Procedure
Intervention Name(s)
Massage session
Intervention Description
Participants in the intervention group are provided with the 5-minute massage session in the medial and lateral gastrocnemius muscle (dominant leg).
Primary Outcome Measure Information:
Title
Changes in maximal displacement of the medial and lateral gastrocnemius muscle
Description
The maximal radial displacement is produced in the muscle belly after the electrical stimulation. Measuring device: TMG S2
Time Frame
1) baseline, 2) immediately after the massage session
Title
Changes in delay time of the medial and lateral gastrocnemius muscle
Description
Delay time is the time in which the muscle displacement increases to 10% after the electrical stimulation. Measuring device: TMG S2
Time Frame
1) baseline, 2) immediately after the massage session
Title
Changes in contraction time of the medial and lateral gastrocnemius muscle
Description
Contraction time is the time between 10% and 90% of the muscle displacement after the electrical stimulation. Measuring device: TMG S2
Time Frame
1) baseline, 2) immediately after the massage session
Title
Changes in sustain time of the medial and lateral gastrocnemius muscle
Description
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
Time Frame
1) baseline, 2) immediately after the massage session
Title
Changes in relaxation time of the medial and lateral gastrocnemius muscle
Description
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
Time Frame
1) baseline, 2) immediately after the massage session
Title
Changes in oscillation frequency of the medial and lateral gastrocnemius muscle
Description
The oscillation frequency characterizes the tension of muscle tissue. Measuring device: MyotonPRO
Time Frame
1) baseline, 2) immediately after the massage session
Title
Changes in dynamic stiffness of the medial and lateral gastrocnemius muscle
Description
The dynamic stiffness corresponds to the soft tissues' capacity to resist external forces. Measuring device: MyotonPRO
Time Frame
1) baseline, 2) immediately after the massage session
Title
Changes in logarithmic decrement of the medial and lateral gastrocnemius muscle
Description
Logarithmic decrement is the dissipation of the tissue oscillation. Measuring device: MyotonPRO
Time Frame
1) baseline, 2) immediately after the massage session
Title
Changes in mechanical stress relaxation time of the medial and lateral gastrocnemius muscle
Description
Mechanical stress relaxation time is the time needed for the muscle to recover to its initial shape. Measuring device: MyotonPRO
Time Frame
1) baseline, 2) immediately after the massage session
Title
Changes in creep of the medial and lateral gastrocnemius muscle
Description
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
Time Frame
1) baseline, 2) immediately after the massage session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Krzysztof Kassolik, Phd
Phone
+48 504 549 427
Email
p665569523@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marcin Piwecki
Phone
+48 665 569 523
Email
p665569523@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krzysztof Kassolik
Organizational Affiliation
Wroclaw University of Health and Sport Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Wroclaw University of Health and Sport Sciences
City
Wrocław
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Analysis of the Impact of 5-minute Massage Session on the Muscle Stiffness and Tone

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