Fascia LataNCT04695561
Effects of Different Myofascial Release Techniques on Iliotibial Band Tightness
A study testing Self Myofascial Relaxation and Instrument Assisted Soft Tissue Mobilization in people with Fascia Lata, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate the effects of foam roller and instrument assisted soft tissue mobilization on pain, functionality and performance in athletes with iliotibial band tightness Read more about this study
- Who is it for?
- Ages 18 to 30 years, men only
- Conditions the study is for
- Fascia Lata
- What is being tested?
- Self Myofascial Relaxation and Instrument Assisted Soft Tissue Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Nov 2020to 15 Mar 2021
- 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 30 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- The leg inclinations of the athletes evaluated with the Ober test will be measured with an inclinometer and the athletes below 25 degrees will be included in the study.
- Age between 18 and 30 years
- Agree to participate in the study,
Who cannot join
- Not having surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Different Myofascial Release Techniques on Pain, Functionality and Performance in Athletes With Iliotibial Band Tightness
The aim of the study is to investigate the effects of foam roller and instrument assisted soft tissue mobilization on pain, functionality and performance in athletes with iliotibial band tightness
Read the detailed description
Subject In this study, the effects of foam roller myofascial massage and instrument assisted soft tissue mobilization (IASTM) (massage performed by applying light pressure to the skin with a tool) on pain, functionality and performance will be investigated in athletes with iliotibial band tightness. There are studies on both IASTM and Foam Roller Massage in the literature and they are popular applications recently. However, within our knowledge, when we look at the Turkish and English literature, no study has been found that compares these two therapeutic massages in terms of pain, functionality and performance.
Purpose Poor posture, facial traumas and stiffness cause tension in the fascia of that region and result in pain. This disrupts the complementary mechanism of the fascia, causing the structures attached to the fascia to be out of the normal sequence. Facial problems have an important place in athletes. Facial problems cause pain in the athlete, reducing the athlete's sportive performance and negatively affecting their functionality. In order to prevent these limitations and accelerate the recovery, the rehabilitation process is started after the surgery. Various exercises and myofascial massages are routinely applied to problems seen in athletes. Myofascial massage techniques can be used in athletes' problems for many positive reasons such as effective in a short time, rapid results, high success rate, risk-free and painless if experts do. Thanks to the findings to be obtained from our study, it is aimed to contribute to the literature with objective, evidence-based results in this field.
- Conditions
- Fascia Lata
- Being tested
- Self Myofascial Relaxation, Instrument Assisted Soft Tissue Mobilization, Only Exercise (Control)
- Keywords
- Fascia Lata, Fascia, Massage, Musculoskeletal Manipulations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Myofascial RelaxationOther
Total of 12 times for 6 weeks
Instrument Assisted Soft Tissue MobilizationOther
Total of 12 times for 6 weeks
Only Exercise (Control)Other
Every day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Self Myofascial Relaxation | Experimental | In addition to the exercises applied to the participants in the control group, the participants in this group used Foam Roller, which was performed with the principle of painless movement 2 times a week for a total of 12 times a week for 6 weeks. Receives: Other: Self Myofascial Relaxation |
| Instrument Assisted Soft Tissue Mobilization | Experimental | In addition to the exercises applied to the participants in the control group, the participants in this group used Instrument Assisted Soft Tissue Mobilization, which was performed with the principle of painless movement 2 times a week for a total of 12 times a week for 6 weeks. Receives: Other: Instrument Assisted Soft Tissue Mobilization |
| Only Exercise (Control) | Active comparator | Stretching and strengthening exercises for the hip flexors, hip extensors and iliotibial band were shown to the participants in the control group for 6 weeks every day of the week. Receives: Other: Only Exercise (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Isokinetic Strength at 6 weeks
It is a very effective force work since the muscles are dynamically loaded at their maximum capacity at all points of the angle of motion during isokinetic contraction. In our study, hip flexor-extensor, hip abductor-adductor, knee flexor-extensor muscle strength will be evaluated with the humac norm 2004 cybex isokinetic device.
Measured: [Baseline and 6 weeks]
Change from baseline in Pain Threshold Score at 6 weeks
Pressure pain threshold is expressed as the lowest pressure giving pain or discomfort. "J Tech Commander Algometer" will be used to evaluate the pain threshold in our study. The device is a digital pain threshold measuring device and 1 cm. It consists of a sensor connected to a diameter hard tip. Pain in individuals with iliotibial band tension is 3 cm above the femur lateral condyle. The participant will be asked to stop the measurement by warning the therapist as soon as the pressure turns into a painful feeling. the minimum values mean worse outcome the maximum values mean better outcome
Measured: [Baseline and 6 weeks]
Change from baseline in Vertical Jump Distance at 6 weeks
Vertical jump test will be used to measure the lower extremity explosive power of the subjects. A digital Jump Meter will be used to measure the vertical jump distance of the subjects. Before the test, the subjects will be allowed enough trials to reach the maximal height. For the test, subjects will be asked to stand on the Jump Meter's mat. Subjects will be instructed to jump to the greatest possible distance with both feet, allowing their arms and feet to swing. After the splash, they should land on the mat as a double foot. The test will be repeated 3 times, a 1-minute rest interval will be given between tests and the best grade will be recorded in cm
Measured: [Baseline and 6 weeks]
Change from baseline in Pro-Agility Test at 6 weeks
The test called pro-agility will be used. At the starting point, the athlete will spread his legs, turn with the command to start and run fast to the right, touching the line 5 yards (4.6m) away with his right hand. The athlete will then turn left, quickly running to the ground 10 yards (9.1 m) away and touching the far line with his left hand. The athlete will turn back from the right and quickly run 5 yards between the start and the finish line, and the test will be completed.
Measured: [Baseline and 6 weeks]
Change from baseline in Postural Control at 6 weeks
Postural control performances of the athletes will be determined by the Balance Error Scoring System. The original name of the test is Balance Error Scoring System (BESS) and it has been translated into Turkish as Balance Error Scoring System. Test, subjects 20 sec. They are required to maintain their test positions under 6 different conditions, eyes closed and without any support: flat and foam surface and 3 separate stance positions (double leg, single leg and tandem). A gym floor will be used for the flat surface. For the foam surface, a medium density foam block of 50x41x6 cm will be used (Airex Balance Pad, Alcan Airex AG, CH-5643 Sins / Switzerland)
Measured: [Baseline and 6 weeks]
Change from baseline in Modified Star Balance Test at 6 weeks
Modified Star Balance Test is a method adapted from the Star Excursion Balance Test, which originally evaluated reaching in eight different directions, and is used in balance assessment. Extension directions were reduced to three as anterior, posteromedial and postero-lateral. The inter-rater and intra-rater reliability of Modified Star Balance Test was found to be quite high (95% CI: 0.88-0.99 p <0.01)
Measured: [Baseline and 6 weeks]
Change from baseline in Range of Motion (ROM) Assessment at 6 weeks
ROM of the lower extremities will be evaluated with a goniometer.
Measured: [Baseline and 6 weeks]
Change from baseline in Lower extremity functional scale (LEFS) at 6 weeks
It is a patient-reported questionnaire that evaluates the functional status of patients with musculoskeletal dysfunction affecting their lower extremities. The questionnaire consists of 20 items; each item has five numerical response categories (0-4). The total score ranges from 0 to 80, and higher scores are considered to be better functional status. It has been shown to have a sensitive scale to detect changes in functional levels immediately after surgery.
Measured: [Baseline and 6 weeks]
Change from baseline in OBER Test at 6 weeks
The iliotibial tract consists of the fascia lata and the iliotibial band. The iliotibial band is formed by the thickening of the fascia lata lateral to the thigh. The Ober test is used to evaluate Tensor Fascia Lata and iliotibial band tightness. The patient lies in the supine position with the hips and knees extended. The untested leg is brought to abduction, the other leg is moved next to the leg in abduction (hyperadduction). If the Tensor Fascia Lata is short, the leg tested does not go into hyperadduction. In the study conducted by Ferber et al. (2010) regarding the Ober test and iliotibial band flexibility measurements, 300 participants were evaluated with the inclinometer and the average was found to be 24.59 degrees
Measured: [Baseline and 6 weeks]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start23 Nov 2020
- Primary completion14 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fascia LataStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ertuğrul Demirdel, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695561
- Sponsor's protocol ID
- KaratayUSonmezTez
- Status last verified
- Nov 2020
- First submitted
- 19 Nov 2020
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Different Myofascial Release Techniques on Pain, Functionality and Performance in Athletes With Iliotibial Band Tightness
- ClinicalTrials.gov ID
- NCT04695561
- Acronym / sponsor ID
- KaratayUSonmezTez
- Conditions
- Fascia Lata
- Keywords
- Fascia Lata, Fascia, Massage, Musculoskeletal Manipulations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 14 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 5 Jan 2021 (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 aim of the study is to investigate the effects of foam roller and instrument assisted soft tissue mobilization on pain, functionality and performance in athletes with iliotibial band tightness
Detailed description
Subject In this study, the effects of foam roller myofascial massage and instrument assisted soft tissue mobilization (IASTM) (massage performed by applying light pressure to the skin with a tool) on pain, functionality and performance will be investigated in athletes with iliotibial band tightness. There are studies on both IASTM and Foam Roller Massage in the literature and they are popular applications recently. However, within our knowledge, when we look at the Turkish and English literature, no study has been found that compares these two therapeutic massages in terms of pain, functionality and performance.
Purpose Poor posture, facial traumas and stiffness cause tension in the fascia of that region and result in pain. This disrupts the complementary mechanism of the fascia, causing the structures attached to the fascia to be out of the normal sequence. Facial problems have an important place in athletes. Facial problems cause pain in the athlete, reducing the athlete's sportive performance and negatively affecting their functionality. In order to prevent these limitations and accelerate the recovery, the rehabilitation process is started after the surgery. Various exercises and myofascial massages are routinely applied to problems seen in athletes. Myofascial massage techniques can be used in athletes' problems for many positive reasons such as effective in a short time, rapid results, high success rate, risk-free and painless if experts do. Thanks to the findings to be obtained from our study, it is aimed to contribute to the literature with objective, evidence-based results in this field.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self Myofascial Relaxation | Experimental | Other: Self Myofascial RelaxationIn addition to the exercises applied to the participants in the control group, the participants in this group used Foam Roller, which was performed with the principle of painless movement 2 times a week for a total of 12 times a week for 6 weeks. |
| Instrument Assisted Soft Tissue Mobilization | Experimental | Other: Instrument Assisted Soft Tissue MobilizationIn addition to the exercises applied to the participants in the control group, the participants in this group used Instrument Assisted Soft Tissue Mobilization, which was performed with the principle of painless movement 2 times a week for a total of 12 times a week for 6 weeks. |
| Only Exercise (Control) | Active comparator | Other: Only Exercise (Control)Stretching and strengthening exercises for the hip flexors, hip extensors and iliotibial band were shown to the participants in the control group for 6 weeks every day of the week. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The leg inclinations of the athletes evaluated with the Ober test will be measured with an inclinometer and the athletes below 25 degrees will be included in the study.
- Age between 18 and 30 years
- Agree to participate in the study,
Key exclusion criteria (1 listed)
- Not having surgery
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 |
|---|---|---|
| Self Myofascial RelaxationTotal of 12 times for 6 weeks | Other | Self Myofascial Relaxation |
| Instrument Assisted Soft Tissue MobilizationTotal of 12 times for 6 weeks | Other | Instrument Assisted Soft Tissue Mobilization |
| Only Exercise (Control)Every day for 6 weeks | Other | Only Exercise (Control) |
Primary outcome
Change from baseline in Isokinetic Strength at 6 weeks
Time frame: [Baseline and 6 weeks]
It is a very effective force work since the muscles are dynamically loaded at their maximum capacity at all points of the angle of motion during isokinetic contraction. In our study, hip flexor-extensor, hip abductor-adductor, knee flexor-extensor muscle strength will be evaluated with the humac norm 2004 cybex isokinetic device.
Change from baseline in Pain Threshold Score at 6 weeks
Time frame: [Baseline and 6 weeks]
Pressure pain threshold is expressed as the lowest pressure giving pain or discomfort. "J Tech Commander Algometer" will be used to evaluate the pain threshold in our study. The device is a digital pain threshold measuring device and 1 cm. It consists of a sensor connected to a diameter hard tip. Pain in individuals with iliotibial band tension is 3 cm above the femur lateral condyle. The participant will be asked to stop the measurement by warning the therapist as soon as the pressure turns into a painful feeling. the minimum values mean worse outcome the maximum values mean better outcome
Change from baseline in Vertical Jump Distance at 6 weeks
Time frame: [Baseline and 6 weeks]
Vertical jump test will be used to measure the lower extremity explosive power of the subjects. A digital Jump Meter will be used to measure the vertical jump distance of the subjects. Before the test, the subjects will be allowed enough trials to reach the maximal height. For the test, subjects will be asked to stand on the Jump Meter's mat. Subjects will be instructed to jump to the greatest possible distance with both feet, allowing their arms and feet to swing. After the splash, they should land on the mat as a double foot. The test will be repeated 3 times, a 1-minute rest interval will be given between tests and the best grade will be recorded in cm
Change from baseline in Pro-Agility Test at 6 weeks
Time frame: [Baseline and 6 weeks]
The test called pro-agility will be used. At the starting point, the athlete will spread his legs, turn with the command to start and run fast to the right, touching the line 5 yards (4.6m) away with his right hand. The athlete will then turn left, quickly running to the ground 10 yards (9.1 m) away and touching the far line with his left hand. The athlete will turn back from the right and quickly run 5 yards between the start and the finish line, and the test will be completed.
Change from baseline in Postural Control at 6 weeks
Time frame: [Baseline and 6 weeks]
Postural control performances of the athletes will be determined by the Balance Error Scoring System. The original name of the test is Balance Error Scoring System (BESS) and it has been translated into Turkish as Balance Error Scoring System. Test, subjects 20 sec. They are required to maintain their test positions under 6 different conditions, eyes closed and without any support: flat and foam surface and 3 separate stance positions (double leg, single leg and tandem). A gym floor will be used for the flat surface. For the foam surface, a medium density foam block of 50x41x6 cm will be used (Airex Balance Pad, Alcan Airex AG, CH-5643 Sins / Switzerland)
Change from baseline in Modified Star Balance Test at 6 weeks
Time frame: [Baseline and 6 weeks]
Modified Star Balance Test is a method adapted from the Star Excursion Balance Test, which originally evaluated reaching in eight different directions, and is used in balance assessment. Extension directions were reduced to three as anterior, posteromedial and postero-lateral. The inter-rater and intra-rater reliability of Modified Star Balance Test was found to be quite high (95% CI: 0.88-0.99 p <0.01)
Change from baseline in Range of Motion (ROM) Assessment at 6 weeks
Time frame: [Baseline and 6 weeks]
ROM of the lower extremities will be evaluated with a goniometer.
Change from baseline in Lower extremity functional scale (LEFS) at 6 weeks
Time frame: [Baseline and 6 weeks]
It is a patient-reported questionnaire that evaluates the functional status of patients with musculoskeletal dysfunction affecting their lower extremities. The questionnaire consists of 20 items; each item has five numerical response categories (0-4). The total score ranges from 0 to 80, and higher scores are considered to be better functional status. It has been shown to have a sensitive scale to detect changes in functional levels immediately after surgery.
Change from baseline in OBER Test at 6 weeks
Time frame: [Baseline and 6 weeks]
The iliotibial tract consists of the fascia lata and the iliotibial band. The iliotibial band is formed by the thickening of the fascia lata lateral to the thigh. The Ober test is used to evaluate Tensor Fascia Lata and iliotibial band tightness. The patient lies in the supine position with the hips and knees extended. The untested leg is brought to abduction, the other leg is moved next to the leg in abduction (hyperadduction). If the Tensor Fascia Lata is short, the leg tested does not go into hyperadduction. In the study conducted by Ferber et al. (2010) regarding the Ober test and iliotibial band flexibility measurements, 300 participants were evaluated with the inclinometer and the average was found to be 24.59 degrees
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 18 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Fascia Lata
Not yet recruiting
Muscle Damage of the TFL (Tensor Fascia Latae) During Total Hip Arthroplasty (THA) Through Direct Anterior Approach (DAA)
Hip Joint, Surgery
RecruitingObservational study
Impact of Tensor Fascia Lata Stretch on Vastus Medialis Obliqus Activity
Patellofemoral Pain Syndrome
Recruiting
Comparison of Clinical Value in the Use of the Fascia Lata and Temporal Muscle Fascia in the Reconstruction of the Dura in the Sellar Region
Skull Defect, Transplant Complication
Recruiting
MPFLR With Fascia Lata Allograft, Based on Isometry Assessment + Elmslie-Trillat TTO
Lateral Patellofemoral Dislocation Closed Traumatic, Lateral Patellar Luxation
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.
Ertuğrul Demirdel principal investigator
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Myofascial Relaxation and Instrument Assisted Soft Tissue Mobilization in people with Fascia Lata, run by KTO Karatay University at 1 site in Turkey (Türkiye).
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 1 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 18 Mar 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 Turkey (Türkiye). 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?
Change from baseline in Isokinetic Strength at 6 weeks (time frame: [Baseline and 6 weeks]). The study lists 9 primary outcomes in all. 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 18 Mar 2021.