NCT06009367

Brief Summary

The investigators conducted a prospective randomized controlled trial on the female and male handball players from the Izola Handball Club (Slovenia) who volunteered to participate in the study. Data were collected in the first part of the competition season 2022/2023. The participants were randomly divided into investigated and control groups so that each group had approximately the same number of participants regarding sex and age. The Fascial manipulation (FM) was performed in the investigated group, whereas, in the control group, the participants did not receive the FM. Demographics (sex, age, height, weight, throwing shoulder, playing position, years of playing) were collected. The study protocol complied with the Declaration of Helsinki and was approved by the National Medical Ethics Committee of the Republic of Slovenia (0120-78/2022/9). The aim of this research was to determine whether and how FM affects IR, HADD ROM and the strength of ER in handball players. The hypotheses include: (1) an increase in IR, HADD ROM, and strength of ER immediately after FM compared to the control group, (2) maintenance of increased ROM and ER strength one month after FM compared to baseline and the control group, (3) a decrease in the subjective feeling of tightness immediately and one month after and (4) the size of the FM effect increases with years of playing and vice versa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

1 month

First QC Date

August 9, 2023

Last Update Submit

August 22, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • The immediate effect of Fascial Manipulation (FM) on the shoulder joint internal rotation (IR) and horizontal adduction (HADD) range of motion (ROM)

    Investigated the difference in the shoulder joint internal rotation (IR) and shoulder joint horizontal adduction (HADD) ROM before and immediately after FM in both groups. A classic goniometer was used to record ROM measurements for IR and HADD in degrees (°).

    immediately after FM

  • The immediate effect of Fascial Manipulation (FM) on the shoulder joint external rotation (ER) strength

    Investigated the difference in the strength of ER before and immediately after FM in both groups. The Easy Force© digital dynamometer was used to determine the strength of the ER. Maximal isometric strength was measured in newtons per kilogram (N/kg).

    immediately after FM

Secondary Outcomes (2)

  • The effect of Fascial Manipulation (FM) on the shoulder joint internal rotation (IR) and horizontal adduction (HADD) range of motion (ROM) one month after FM

    27-34 days (one month)

  • The effect of Fascial Manipulation (FM) on the shoulder joint external rotation (ER) strength one month after FM

    27-34 days (one month)

Study Arms (2)

Investigated group with fascial manipulation

EXPERIMENTAL

Participants in this group received one treatment of fascial manipulation by Stecco method

Procedure: Fascial Manipulation by Stecco method

Control group with no intervention

NO INTERVENTION

Participants in this group received no treatment

Interventions

Fascial Manipulation (FM) is a method carefully developed by members of the Stecco family after many years of research. FM involves deep kneading of the muscle fascia at specific points called centers of coordination (CC) and centers of fusion (CF) along myofascial sequences, diagonals, and spirals. It has been proposed that the friction caused by manipulation creates localized heat and that, due to the thermosensitive characteristics of fascia, this heat facilitates the transition of hyaluronic acid within the extracellular matrix from a condensed state to a more fluid state, thus restoring the gliding properties of fascia.

Investigated group with fascial manipulation

Eligibility Criteria

Age15 Years - 33 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Asymptomatic and healthy handball players from Izola Handball Club (Slovenia)
  • Both male and female participants who volunteer for the study and belong to cadet, junior, and senior handball teams
  • All participants aged 18 years and older, provided informed consent to participate in the study, whereas participants under the age of 18 need their parents or guardians to sign the informed consent form on their behalf.

You may not qualify if:

  • A recent upper extremity injury or surgery that hinders the player's ability to participate in the game of handball for the past three months
  • Any history of previous shoulder surgery
  • The playing position of goalkeeper.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izola Handball Club

Izola, 6310, Slovenia

Location

Related Publications (1)

  • Baric A, Jesensek Papez B, Bastic M, Kelc R, Brumat P, Stecco A. The Impact of Fascial Manipulation(R) on Posterior Shoulder Tightness in Asymptomatic Handball Players: A Randomized Controlled Trial. Diagnostics (Basel). 2024 Sep 7;14(17):1982. doi: 10.3390/diagnostics14171982.

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: One investigated group with intervention and one control group without intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator, Physiotherapist, Master of Health Science

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 24, 2023

Study Start

September 1, 2022

Primary Completion

October 15, 2022

Study Completion

October 15, 2022

Last Updated

August 24, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations