Connective Tissue DefectNCT06009367
Fascial Manipulation Effect on Shoulder Range of Motion and Strength in Handball Players
A study testing Fascial Manipulation by Stecco method in people with Connective Tissue Defect and Fascia; Anomaly, run by Anja Baric at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 33 yearsHealthy volunteers can take part
- Conditions the study is for
- Connective Tissue Defect, Fascia; Anomaly
- What is being tested?
- Fascial Manipulation by Stecco method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Sep 2022to 15 Oct 2022
- 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 15 to 33 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Fascial Manipulation Technique by Stecco on the Shoulder Range of Motion and External Rotation Strength of Asymptomatic Handball Players
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.
Read the detailed description
All participants aged 18 or older signed informed consent to participate in the study. For participants under 18 years of age, informed consent was signed by their parents or legal guardians. Exclusion criteria were prior upper extremity injury or upper extremity surgery preventing the player from playing in the last three months, any previous shoulder surgery, and goalkeeper position. A cluster random sampling strategy was used. The participants were randomly divided into investigated and control groups so that each group had approximately the same number of units regarding sex and age. In the investigated group, the Fascial manipulation (FM) was performed, whereas, in the control group, the participants did not receive the FM.
One session of Fascial Manipulation® by Stecco was chosen as the therapeutic procedure. The principal investigator who performed the FM in the investigated group is a qualified therapist with extensive knowledge in manual therapy and a certificate in FM Levels I and II. Based on the collected information (a complete medical history, including the chronology of any traumatic events, fractures, significant musculoskeletal dysfunctions, scars and surgical procedures, specific range of motion, and palpation examinations) and according to the Stecco model for the interpretation of the dysfunction of the fascial system, the therapist selected an individual combination of condensed points of treatment (centers of coordination - CC and/or centers of fusion - CF). All CC and/or CF points that were treated in an individual subject were recorded.
All participants completed three test sessions (pre-test, immediate post-test, and one-month post-test). The immediate post-test measurements were recorded directly after the application of the FM in the investigated group and after a one-minute waiting period in the control group. Testing was repeated 27-34 days (one month) after FM was performed. All three measurements for both groups were performed in the same way. All the measurements were performed by the two independent examiners - experienced physical therapists, whereby FM was performed only by the principal investigator-experienced physical therapist who did not participate in the measurements. Before the measurements, participants completed a specific standard warm-up for their team consisting of gentle jogging, static and dynamic full-body stretching. The warm-up was not standardized for this study.
Range of motion (ROM) measurements for internal rotation (IR) and horizontal adduction (HADD) were recorded using a classic goniometer. For the HADD assessment, participants were positioned supine on a standard examination table with both shoulders aligned. The examiner stood on top of the table, facing the participant's head, and stabilized the lateral edge of the scapula. The participant's upper limb was positioned at 90 degrees of GH abduction with 90 degrees of elbow flexion. The examiner held the subject's arm distal to the elbow and passively moved it into HADD. At the first point of resistance, a second examiner used a digital inclinometer to record the amount of motion in degrees (°) by aligning it with the humerus.
Passive IR measurements were taken with the participant lying supine on an examination table, with the shoulder at 90 degrees of abduction in the frontal plane and the elbow at 90 degrees of flexion. The examiner applied a posterior stabilizing force to the acromial process of the scapula and internally rotated the upper limb until the first point of resistance. A second investigator then recorded the amount of movement in degrees by aligning the digital inclinometer with the axis of the forearm.
The Easy Force© digital dynamometer was used to determine the strength of the external rotation (ER). Maximal isometric strength was measured in Newtons per kilogram (N/kg). Subjects lay prone, with the shoulder abducted to 90° in the frontal plane and in neutral rotation. The first examiner placed the dynamometer strap around the wrist, 2cm proximal to the ulnar styloid process. The tape on the other side of the dynamometer was fixed in a stand next to the table, in extension with the wrist. The second examiner fixed the humerus on the distal side just above the elbow to limit the motion of the humerus. According to standardized testing instructions, the procedure was as follows: one familiarization trial, then three maximal isometric tests. Participants were asked to gradually build up their strength to maximal effort over a two-second period and finally to hold their maximal effort for three seconds. The best measurement from three trials, expressed in N/kg, was used for analysis.
One session of Fascial Manipulation® by Stecco was chosen as the therapeutic procedure for the investigated group. The principal investigator who performed the FM is a qualified therapist with extensive knowledge in manual therapy and holds certificates in FM Levels I and II. The therapist utilized the Stecco model to interpret the dysfunction of the fascial system based on comprehensive information collected, including the participant's complete medical history, traumatic events, fractures, musculoskeletal dysfunctions, scars, surgical procedures, specific range of motion, and palpation examinations. Using this information, the therapist selected an individualized combination of condensed treatment points, known as centers of coordination (CC) and/or centers of fusion (CF). All CC and/or CF points treated in each individual subject were recorded for documentation purposes.
- Conditions
- Connective Tissue Defect, Fascia; Anomaly
- Being tested
- Fascial Manipulation by Stecco method
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascial Manipulation by Stecco methodProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Investigated group with fascial manipulation | Experimental | Participants in this group received one treatment of fascial manipulation by Stecco method Receives: Procedure: Fascial Manipulation by Stecco method |
| Control group with no intervention | No intervention | Participants in this group received no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (°).
Measured: 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).
Measured: 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
Investigated the difference in values of internal rotation (IR) and horizontal adduction (HADD) range of motion (ROM) one month after FM in both groups. A classic goniometer was used to record ROM measurements for IR and HADD in degrees (°).
Measured: 27-34 days (one month)
The effect of Fascial Manipulation (FM) on the shoulder joint external rotation (ER) strength one month after FM
Investigated the difference in values of ER strength one month 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).
Measured: 27-34 days (one month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Sep 2022
- Primary completion15 Oct 2022
- Study completion15 Oct 2022
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 Connective Tissue DefectStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One investigated group with intervention and one control group without intervention
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anja Baric
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anja Baric, Anja Barič
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009367
- Sponsor's protocol ID
- FM2223
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39272766
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fascial Manipulation Technique by Stecco on the Shoulder Range of Motion and External Rotation Strength of Asymptomatic Handball Players
- ClinicalTrials.gov ID
- NCT06009367
- Acronym / sponsor ID
- FM2223
- Conditions
- Connective Tissue Defect, Fascia; Anomaly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Anja BaricUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 24 Aug 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 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.
Detailed description
All participants aged 18 or older signed informed consent to participate in the study. For participants under 18 years of age, informed consent was signed by their parents or legal guardians. Exclusion criteria were prior upper extremity injury or upper extremity surgery preventing the player from playing in the last three months, any previous shoulder surgery, and goalkeeper position. A cluster random sampling strategy was used. The participants were randomly divided into investigated and control groups so that each group had approximately the same number of units regarding sex and age. In the investigated group, the Fascial manipulation (FM) was performed, whereas, in the control group, the participants did not receive the FM.
One session of Fascial Manipulation® by Stecco was chosen as the therapeutic procedure. The principal investigator who performed the FM in the investigated group is a qualified therapist with extensive knowledge in manual therapy and a certificate in FM Levels I and II. Based on the collected information (a complete medical history, including the chronology of any traumatic events, fractures, significant musculoskeletal dysfunctions, scars and surgical procedures, specific range of motion, and palpation examinations) and according to the Stecco model for the interpretation of the dysfunction of the fascial system, the therapist selected an individual combination of condensed points of treatment (centers of coordination - CC and/or centers of fusion - CF). All CC and/or CF points that were treated in an individual subject were recorded.
All participants completed three test sessions (pre-test, immediate post-test, and one-month post-test). The immediate post-test measurements were recorded directly after the application of the FM in the investigated group and after a one-minute waiting period in the control group. Testing was repeated 27-34 days (one month) after FM was performed. All three measurements for both groups were performed in the same way. All the measurements were performed by the two independent examiners - experienced physical therapists, whereby FM was performed only by the principal investigator-experienced physical therapist who did not participate in the measurements. Before the measurements, participants completed a specific standard warm-up for their team consisting of gentle jogging, static and dynamic full-body stretching. The warm-up was not standardized for this study.
Range of motion (ROM) measurements for internal rotation (IR) and horizontal adduction (HADD) were recorded using a classic goniometer. For the HADD assessment, participants were positioned supine on a standard examination table with both shoulders aligned. The examiner stood on top of the table, facing the participant's head, and stabilized the lateral edge of the scapula. The participant's upper limb was positioned at 90 degrees of GH abduction with 90 degrees of elbow flexion. The examiner held the subject's arm distal to the elbow and passively moved it into HADD. At the first point of resistance, a second examiner used a digital inclinometer to record the amount of motion in degrees (°) by aligning it with the humerus.
Passive IR measurements were taken with the participant lying supine on an examination table, with the shoulder at 90 degrees of abduction in the frontal plane and the elbow at 90 degrees of flexion. The examiner applied a posterior stabilizing force to the acromial process of the scapula and internally rotated the upper limb until the first point of resistance. A second investigator then recorded the amount of movement in degrees by aligning the digital inclinometer with the axis of the forearm.
The Easy Force© digital dynamometer was used to determine the strength of the external rotation (ER). Maximal isometric strength was measured in Newtons per kilogram (N/kg). Subjects lay prone, with the shoulder abducted to 90° in the frontal plane and in neutral rotation. The first examiner placed the dynamometer strap around the wrist, 2cm proximal to the ulnar styloid process. The tape on the other side of the dynamometer was fixed in a stand next to the table, in extension with the wrist. The second examiner fixed the humerus on the distal side just above the elbow to limit the motion of the humerus. According to standardized testing instructions, the procedure was as follows: one familiarization trial, then three maximal isometric tests. Participants were asked to gradually build up their strength to maximal effort over a two-second period and finally to hold their maximal effort for three seconds. The best measurement from three trials, expressed in N/kg, was used for analysis.
One session of Fascial Manipulation® by Stecco was chosen as the therapeutic procedure for the investigated group. The principal investigator who performed the FM is a qualified therapist with extensive knowledge in manual therapy and holds certificates in FM Levels I and II. The therapist utilized the Stecco model to interpret the dysfunction of the fascial system based on comprehensive information collected, including the participant's complete medical history, traumatic events, fractures, musculoskeletal dysfunctions, scars, surgical procedures, specific range of motion, and palpation examinations. Using this information, the therapist selected an individualized combination of condensed treatment points, known as centers of coordination (CC) and/or centers of fusion (CF). All CC and/or CF points treated in each individual subject were recorded for documentation purposes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- One investigated group with intervention and one control group without intervention
| Arm | Type | Receives |
|---|---|---|
| Investigated group with fascial manipulation | Experimental | Procedure: Fascial Manipulation by Stecco methodParticipants in this group received one treatment of fascial manipulation by Stecco method |
| Control group with no intervention | No intervention | –Participants in this group received no treatment |
Who may qualify
- Ages
- 15 to 33 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Fascial Manipulation by Stecco methodFascial 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. | Procedure or surgery | Investigated group with fascial manipulation |
Primary outcome
The immediate effect of Fascial Manipulation (FM) on the shoulder joint internal rotation (IR) and horizontal adduction (HADD) range of motion (ROM)
Time frame: immediately after FM
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 (°).
The immediate effect of Fascial Manipulation (FM) on the shoulder joint external rotation (ER) strength
Time frame: immediately after FM
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).
2 secondary outcomes
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
Time frame: 27-34 days (one month)
The effect of Fascial Manipulation (FM) on the shoulder joint external rotation (ER) strength one month after FM
Time frame: 27-34 days (one month)
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 24 Aug 2023.
- Derived from this study: PubMed 39272766Baric 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascial Manipulation by Stecco method in people with Connective Tissue Defect and Fascia; Anomaly, run by Anja Baric at 1 site in Slovenia.
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 3 inclusion and 3 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 24 Aug 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 Slovenia. 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?
The immediate effect of Fascial Manipulation (FM) on the shoulder joint internal rotation (IR) and horizontal adduction (HADD) range of motion (ROM) (time frame: immediately after FM). The study lists 2 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 NCT06009367, 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 24 Aug 2023.