NCT06493149

Brief Summary

The study design is a randomised, controlled, parallel, two-arm trial. The subjects are randomly assigned to one of the study groups: the intervention group or the control group. The study will analyze the applicability of the tensegrity principle in the massage therapy. The main aim of this study is to examine if the tensegrity principle can be used in massage therapy to increase the effectiveness of the intervention. Contractile and passive mechanical properties are assessed before and after the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jul 2024

Typical duration for not_applicable healthy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

19 days

First QC Date

June 26, 2024

Last Update Submit

April 27, 2026

Conditions

Keywords

Massage therapy, tensegrity

Outcome Measures

Primary Outcomes (30)

  • Change in maximal displacement of the deltoid muscle after therapy compared to baseline

    The maximal radial displacement is produced in the muscle belly after the electrical stimulation. Measuring device: TMG S2, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in maximal displacement of the latissimus dorsi muscle after therapy compared to baseline

    The maximal radial displacement is produced in the muscle belly after the electrical stimulation. Measuring device: TMG S2, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in maximal displacement of the and peroneus longus muscle after therapy compared to baseline

    The maximal radial displacement is produced in the muscle belly after the electrical stimulation. Measuring device: TMG S2, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in delay time of the deltoid muscle after therapy compared to baseline.

    Delay time is the time in which the muscle displacement increases to 10% after the electrical stimulation. Measuring device: TMG S2, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in delay time of the latissimus dorsi muscle after therapy compared to baseline.

    Delay time is the time in which the muscle displacement increases to 10% after the electrical stimulation. Measuring device: TMG S2, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in delay time of the peroneus longus muscle after therapy compared to baseline.

    Delay time is the time in which the muscle displacement increases to 10% after the electrical stimulation. Measuring device: TMG S2, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in contraction time of the deltoid muscle after therapy compared to baseline.

    Contraction time is the time between 10% and 90% of the muscle displacement after the electrical stimulation. Measuring device: TMG S2, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in contraction time of the latissimus dorsi muscle after therapy compared to baseline.

    Contraction time is the time between 10% and 90% of the muscle displacement after the electrical stimulation. Measuring device: TMG S2, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in contraction time of the peroneus longus muscle after therapy compared to baseline.

    Contraction time is the time between 10% and 90% of the muscle displacement after the electrical stimulation. Measuring device: TMG S2, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in sustain time of the deltoid muscle after therapy compared to baseline.

    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, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in sustain time of the latissimus dorsi muscle after therapy compared to baseline.

    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, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in sustain time of the peroneus longus muscle after therapy compared to baseline.

    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, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in relaxation time of the peroneus longus muscle after therapy compared to baseline.

    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, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in relaxation time of the deltoid muscle after therapy compared to baseline.

    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, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in relaxation time of the latissimus dorsi muscle after therapy compared to baseline.

    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, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in oscillation frequency of the deltoid muscle after therapy compared to baseline.

    The oscillation frequency characterizes the tension of muscle tissue. Measuring device: MyotonPRO, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in oscillation frequency of the latissimus dorsi muscle after therapy compared to baseline.

    The oscillation frequency characterizes the tension of muscle tissue. Measuring device: MyotonPRO, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in oscillation frequency of the peroneus longus muscle after therapy compared to baseline.

    The oscillation frequency characterizes the tension of muscle tissue. Measuring device: MyotonPRO, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in dynamic stiffness of the deltoid muscle muscle after therapy compared to baseline.

    The dynamic stiffness corresponds to the soft tissues' capacity to resist external forces. Measuring device: MyotonPRO, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in dynamic stiffness of the latissimus dorsi muscle after therapy compared to baseline.

    The dynamic stiffness corresponds to the soft tissues' capacity to resist external forces. Measuring device: MyotonPRO, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in dynamic stiffness of the peroneus longus muscle after therapy compared to baseline.

    The dynamic stiffness corresponds to the soft tissues' capacity to resist external forces. Measuring device: MyotonPRO, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in logarithmic decrement of the deltoid muscle after therapy compared to baseline.

    Logarithmic decrement is the dissipation of the tissue oscillation. Measuring device: MyotonPRO, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in logarithmic decrement of the latissimus dorsi muscle after therapy compared to baseline.

    Logarithmic decrement is the dissipation of the tissue oscillation. Measuring device: MyotonPRO, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in logarithmic decrement of the peroneus longus muscle after therapy compared to baseline.

    Logarithmic decrement is the dissipation of the tissue oscillation. Measuring device: MyotonPRO, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in mechanical stress relaxation time of the deltoid muscle after therapy compared to baseline.

    Mechanical stress relaxation time is the time needed for the muscle to recover to its initial shape. Measuring device: MyotonPRO, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in mechanical stress relaxation time of the latissimus dorsi muscle after therapy compared to baseline.

    Mechanical stress relaxation time is the time needed for the muscle to recover to its initial shape. Measuring device: MyotonPRO, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in mechanical stress relaxation time of the peroneus longus muscle after therapy compared to baseline.

    Mechanical stress relaxation time is the time needed for the muscle to recover to its initial shape. Measuring device: MyotonPRO, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in creep of the deltoid muscle after therapy compared to baseline.

    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, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in creep of the latissimus dorsi muscle after therapy compared to baseline.

    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, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

  • Change in creep of the peroneus longus muscle after therapy compared to baseline.

    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, Change = (Value after therapy - baseline)

    1) baseline, 2) immediately after the massage session

Study Arms (3)

Tensegrity massage group

EXPERIMENTAL

Participants in the tensegrity massage group are provided with the 5-minute massage session in the anterior compartment muscles of the forearm, tensor fasciae latae muscle, brachioradialis muscle, deltoid muscle, latissimus dorsi muscle and peroneus longus muscle.

Other: Massage therapy

Massage group

ACTIVE COMPARATOR

Participants in the massage group are provided with the 5-minute massage session in the anterior compartment muscles of the forearm, tensor fasciae latae muscle and brachioradialis muscle

Other: Massage therapy

Control group

NO INTERVENTION

Interventions

Participants receive a Swedish massage based on the tensegrity principle.

Massage groupTensegrity massage group

Eligibility Criteria

Age18 Years - 24 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18 and 24 years;
  • healthy individuals, with no lower and upper extremities 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.

You may not qualify if:

  • individuals suffering from neurologic or orthopaedic problems;
  • lower ot upper extremities surgical interventions;
  • cancers;
  • musculoskeletal disorders
  • body mass index 18,5 \> BMI ≥ 25kg/m2
  • the lack of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wroclaw University of Health and Sport Sciences

Wroclaw, Poland

Location

Related Publications (2)

  • Bordoni B, Myers T. A Review of the Theoretical Fascial Models: Biotensegrity, Fascintegrity, and Myofascial Chains. Cureus. 2020 Feb 24;12(2):e7092. doi: 10.7759/cureus.7092.

    PMID: 32226693BACKGROUND
  • Swanson RL 2nd. Biotensegrity: a unifying theory of biological architecture with applications to osteopathic practice, education, and research--a review and analysis. J Am Osteopath Assoc. 2013 Jan;113(1):34-52. doi: 10.7556/jaoa.2013.113.1.34.

    PMID: 23329804BACKGROUND

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Marcin Piwecki, MSc

    Doctoral School of Physical Culture Science, University of Physical Education in Kraków, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: a randomised, controlled, parallel, two-arm trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 9, 2024

Study Start

July 1, 2024

Primary Completion

July 20, 2024

Study Completion

October 31, 2025

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations