Musculoskeletal DisorderNCT06082752
The Analysis of the Impact of 5-minute Massage Session on the Muscle Stiffness and Tone
A study testing Massage session in people with Musculoskeletal Disorder, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Disorder
- What is being tested?
- Massage session
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 20 Oct 2023to 6 Nov 2023
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Musculoskeletal Disorder
- Being tested
- Massage session
- Keywords
- Massage therapy, Muscle tone, Muscle stiffness
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage sessionProcedure or surgery
Participants in the intervention group are provided with the 5-minute massage session in the medial and lateral gastrocnemius muscle (dominant leg).
| Study group | Role | What they receive |
|---|---|---|
| Massage group | Experimental | In the intervention group measures will be taken twice: before and after the 5-minute massage session. Receives: Procedure: Massage session |
| Non-massage group | No intervention | In the control group measures will be taken twice: at the beginning of the meeting and again after 5 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1) baseline, 2) immediately after the massage session
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
Measured: 1) baseline, 2) immediately after the massage session
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
Measured: 1) baseline, 2) immediately after the massage session
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
Measured: 1) baseline, 2) immediately after the massage session
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
Measured: 1) baseline, 2) immediately after the massage session
Changes in oscillation frequency of the medial and lateral gastrocnemius muscle
The oscillation frequency characterizes the tension of muscle tissue. Measuring device: MyotonPRO
Measured: 1) baseline, 2) immediately after the massage session
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
Measured: 1) baseline, 2) immediately after the massage session
Changes in logarithmic decrement of the medial and lateral gastrocnemius muscle
Logarithmic decrement is the dissipation of the tissue oscillation. Measuring device: MyotonPRO
Measured: 1) baseline, 2) immediately after the massage session
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
Measured: 1) baseline, 2) immediately after the massage session
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
Measured: 1) baseline, 2) immediately after the massage session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start20 Oct 2023
- Primary completion5 Nov 2023
- Study completion6 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DisorderStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University School of Physical Education, Krakow, Poland
- Responsible party
- Principal investigator, Krzysztof Kassolik, Phd, Wroclaw University of Health and Sport Sciences
- Investigators
- Krzysztof Kassolik, Study chair, Wroclaw University of Health and Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082752
- Sponsor's protocol ID
- WroclawUHSS
- Status last verified
- Nov 2023
- First submitted
- 7 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piwecki M, Wilk I, Kassolik K. Impact of a 5-min massage session on the gastrocnemius contractile and passive mechanical properties in young adults - A randomized controlled trial. J Bodyw Mov Ther. 2024 Oct;40:899-906. doi: 10.1016/j.jbmt.2024.06.010. Epub 2024 Jun 25.
PubMed 39593693
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analysis of the Impact of 5-minute Massage Session on the Muscle Stiffness and Tone: a Randomised Control Trial
- ClinicalTrials.gov ID
- NCT06082752
- Acronym / sponsor ID
- WroclawUHSS
- Conditions
- Musculoskeletal Disorder
- Keywords
- Massage therapy, Muscle tone, Muscle stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Collaborators
- University School of Physical Education, Krakow, Poland
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 5 Nov 2023 (actual)
- Study completion
- 6 Nov 2023 (actual)
- First posted
- 13 Oct 2023 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage group | Experimental | Procedure: Massage sessionIn the intervention group measures will be taken twice: before and after the 5-minute massage session. |
| Non-massage group | No intervention | –In the control group measures will be taken twice: at the beginning of the meeting and again after 5 minutes. |
Who may qualify
- Ages
- 19 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- pregnant women;
- individuals suffering from neurologic or orthopaedic problems;
- lower limb surgical interventions;
- cancers;
- musculoskeletal disorders
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 |
|---|---|---|
| Massage sessionParticipants in the intervention group are provided with the 5-minute massage session in the medial and lateral gastrocnemius muscle (dominant leg). | Procedure or surgery | Massage group |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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 7 Nov 2023.
- Derived from this study: PubMed 39593693Piwecki M, Wilk I, Kassolik K. Impact of a 5-min massage session on the gastrocnemius contractile and passive mechanical properties in young adults - A randomized controlled trial. J Bodyw Mov Ther. 2024 Oct;40:899-906. doi: 10.1016/j.jbmt.2024.06.010. Epub 2024 Jun 25.
- 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.
Krzysztof Kassolik study chair
Wroclaw University of Health and Sport Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage session in people with Musculoskeletal Disorder, run by Wroclaw University of Health and Sport Sciences 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 6 inclusion and 7 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 7 Nov 2023. 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?
Changes in maximal displacement of the medial and lateral gastrocnemius muscle (time frame: 1) baseline, 2) immediately after the massage session). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06082752, which also lists 1 linked publication.
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 7 Nov 2023.