Rugby PlayerNCT04286061
Instrument-assisted Soft Tissue Mobilization to Improve Mobility and Hip Strength in Semi-professional Rugby Players
A study testing Assisted soft tissue mobilization in people with Rugby Player, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Instrument-assisted soft tissue mobilization is a method that uses different devices to approach the myofascial system in variables such as joint mobility and muscle strength. The objective of the study is to assess the effectiveness of the technique of soft tissue mobilization assisted by instruments in increasing… Read more about this study
- Who is it for?
- Ages 18 to 32 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Rugby Player
- What is being tested?
- Assisted soft tissue mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 2 Mar 2020to 10 Jun 2020
- 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 18 to 32 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male rugby players
- With an age range of 18 to 32 years
- Semi-professionals federated in Spain (category Division of Honor B, group C)
- Who have not had previous injuries to the lower limb in the last 2 months.
Who cannot join
- Subjects who: present any type of sensory alteration in the skin
- Are taking muscle relaxants
- Have skin infections
- Are allergic to the material of the intervention or evaluation tool
- Have not signed the informed consent document.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Physiotherapy Intervention Through the Mobilization of Soft Tissues Assisted by Instruments in the Improvement of Mobility and Hip Strength in Semi-professional Rugby Players. A Randomized Clinical Study
Instrument-assisted soft tissue mobilization is a method that uses different devices to approach the myofascial system in variables such as joint mobility and muscle strength.
The objective of the study is to assess the effectiveness of the technique of soft tissue mobilization assisted by instruments in increasing the mobility of hip abduction and strength of the hip adductor musculature, in semi-professional rugby players federated in Spain of 18 at 32 years old Randomized, simple blind clinical study. 29 rugby players will be randomized to the two study groups: experimental (assisted soft tissue mobilization in the adductor leg muscles) and control (without intervention). The intervention will last 4 weeks, with 1 session per week, approximately 1 or 2 minutes each. The study variables will be hip abduction mobility (goniometry) and the strength of the hip adductor musculature (sphygmomanometry). A descriptive statistical analysis will be carried out calculating the main statistical characteristics. The distribution of normality will be calculated through an analysis of Saphiro Wilk. With the t-student test of repeated measures the differences will be calculated after the evaluations, and through an ANOVA of repeated measures the intra and intersubject effect will be calculated. The effect size will be calculated using the Cohen mean difference formula It is expected to observe an increase in hip abduction, as well as an increase in the strength of the adductor musculature of the hip.
- Conditions
- Rugby Player
- Being tested
- Assisted soft tissue mobilization
- Keywords
- Rugby, Pubalgia, Strength, Range of motion, Instrument-assisted soft tissue mobilization.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assisted soft tissue mobilizationOther
Also called Experimental group
It will be done for 60 seconds, making a total of 30 strokes with the tool in the longitudinal direction to the muscle fibers. The physiotherapist will previously apply some massage cream to the area to be treated (adductor musculature) so that the tool slides at a 45º angle. Landslides will be made from the femoral condyle to the groin, and vice versa, exerting a pressure with the instrument of 3 over 10 on the analog visual scale that the subject feels
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Each session will last 1 or 2 minutes, with one intervention being carried out a week, over a period of 4 weeks. Prior to the start of training, the instrument-assisted soft tissue mobilization technique will be performed Receives: Other: Assisted soft tissue mobilization |
| Control group | No intervention | Players included in the control group will follow their usual training routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline range of motion of hip abduction after treatment and at month
A long arm goniometer will be used, following the protocol described by Nussbaumer et al. . Before collecting the data, participants will perform a 5-minute warm-up on an exercise bike. The athlete will be placed supine, attached to the stretcher with a pelvic girth, with the contralateral leg hanging by the edge of the stretcher. The fixed arm of the goniometer will be placed on the transverse line formed by the superior antero iliac spines and the mobile arm on the longitudinal axis of the thigh, matching the goniometer fulcrum with the superior anterior iliac iliac spine of the lower limb to be evaluated. With the help of another physiotherapist, a passive and complete hip abduction will be performed, and the evaluator, in charge of the goniometer, will take the measurement resulting from the test.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes (1)
Change from baseline strength of the hip adductor muscle after treatment and at month
It will be assessed with a sphygmomanometer. The unit of measure will be millimeters of mercury (mmHg). The athlete will be placed in lateral recumbency with the leg to be evaluated extended and in contact with the stretcher and the contralateral leg at 90º of hip and knee flexion. The athlete will grab with his upper hand to the side of the stretcher and on his lower arm will support his head. The evaluator will place the pressure cuff (folded in thirds and preinflated to 10 mmHg) 5 cm proximally over the medial malleolus and secure it with a cinch that surrounds the stretcher. The athlete will exert a maximum isometric force against the pressure cuff and the webbing for 5 seconds. The test will be repeated 4 times, with a 30 second rest period between repetitions. The highest value of the 4 measurements will be chosen. A higher sphygmomanometer score will indicate greater strength of the hip adductor musculature (25,27).
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start2 Mar 2020
- Primary completion20 May 2020
- Study completion10 Jun 2020
Why it stopped: COVID-19 Lockdown
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rugby PlayerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286061
- Sponsor's protocol ID
- IASTM
- Status last verified
- Sep 2021
- First submitted
- 25 Feb 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Physiotherapy Intervention Through the Mobilization of Soft Tissues Assisted by Instruments in the Improvement of Mobility and Hip Strength in Semi-professional Rugby Players. A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT04286061
- Acronym / sponsor ID
- IASTM
- Conditions
- Rugby Player
- Keywords
- Rugby, Pubalgia, Strength, Range of motion, Instrument-assisted soft tissue mobilization.
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 Lockdown
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 26 Feb 2020 (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.
Instrument-assisted soft tissue mobilization is a method that uses different devices to approach the myofascial system in variables such as joint mobility and muscle strength.
The objective of the study is to assess the effectiveness of the technique of soft tissue mobilization assisted by instruments in increasing the mobility of hip abduction and strength of the hip adductor musculature, in semi-professional rugby players federated in Spain of 18 at 32 years old Randomized, simple blind clinical study. 29 rugby players will be randomized to the two study groups: experimental (assisted soft tissue mobilization in the adductor leg muscles) and control (without intervention). The intervention will last 4 weeks, with 1 session per week, approximately 1 or 2 minutes each. The study variables will be hip abduction mobility (goniometry) and the strength of the hip adductor musculature (sphygmomanometry). A descriptive statistical analysis will be carried out calculating the main statistical characteristics. The distribution of normality will be calculated through an analysis of Saphiro Wilk. With the t-student test of repeated measures the differences will be calculated after the evaluations, and through an ANOVA of repeated measures the intra and intersubject effect will be calculated. The effect size will be calculated using the Cohen mean difference formula It is expected to observe an increase in hip abduction, as well as an increase in the strength of the adductor musculature of the hip.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Assisted soft tissue mobilizationEach session will last 1 or 2 minutes, with one intervention being carried out a week, over a period of 4 weeks. Prior to the start of training, the instrument-assisted soft tissue mobilization technique will be performed |
| Control group | No intervention | –Players included in the control group will follow their usual training routine. |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male rugby players
- With an age range of 18 to 32 years
- Semi-professionals federated in Spain (category Division of Honor B, group C)
- Who have not had previous injuries to the lower limb in the last 2 months.
Key exclusion criteria (5 listed)
- Subjects who: present any type of sensory alteration in the skin
- Are taking muscle relaxants
- Have skin infections
- Are allergic to the material of the intervention or evaluation tool
- Have not signed the informed consent document.
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 |
|---|---|---|
| Assisted soft tissue mobilizationAlso: Experimental groupIt will be done for 60 seconds, making a total of 30 strokes with the tool in the longitudinal direction to the muscle fibers. The physiotherapist will previously apply some massage cream to the area to be treated (adductor musculature) so that the tool slides at a 45º angle. Landslides will be made from the femoral condyle to the groin, and vice versa, exerting a pressure with the instrument of 3 over 10 on the analog visual scale that the subject feels | Other | Experimental group |
Primary outcome
Change from baseline range of motion of hip abduction after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
A long arm goniometer will be used, following the protocol described by Nussbaumer et al. . Before collecting the data, participants will perform a 5-minute warm-up on an exercise bike. The athlete will be placed supine, attached to the stretcher with a pelvic girth, with the contralateral leg hanging by the edge of the stretcher. The fixed arm of the goniometer will be placed on the transverse line formed by the superior antero iliac spines and the mobile arm on the longitudinal axis of the thigh, matching the goniometer fulcrum with the superior anterior iliac iliac spine of the lower limb to be evaluated. With the help of another physiotherapist, a passive and complete hip abduction will be performed, and the evaluator, in charge of the goniometer, will take the measurement resulting from the test.
1 secondary outcome
Change from baseline strength of the hip adductor muscle after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: Undecided
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 Assisted soft tissue mobilization in people with Rugby Player, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 2 Sep 2021. 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 Spain. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change from baseline range of motion of hip abduction after treatment and at month (time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2021.