Hamstring InjuryNCT05702593
Immediate Effects of Hamstring Stretching Alone or Combined With Myofascial Release
A study testing Static stretching and Myofascial Release in people with Hamstring Injury and Masseter, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
To assess the immediate effects of hamstring stretching alone or combined with myofascial release of the hamstring muscle on masseter muscle activity, pressure pain threshold, active mouth opening, hamstring flexibility, and forward head flexed posture in recreationally active participants. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Hamstring Injury, Masseter, Myofascial Release
- What is being tested?
- Static stretching and Myofascial Release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jul 2022to 20 Feb 2023
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals who had no previous hamstring injury
- Individuals had a Straight Leg Raise test <80°
- Individuals had a pressure-pain threshold difference between two symmetrical points not exceeding 2 kg/cm2
- Individuals who had no previous hamstring injury had no deviation during mouth opening and closing
Who cannot join
- acute low back pain or musculoskeletal pain in the lower extremities
- recent spinal surgery
- previous whiplash injury
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Caglar Soylu
Ankara, Keçiören, 06010
About this study
Official title: The Immediate Effects of Hamstring Stretching Alone or Combined With Myofascial Release of the Hamstring Muscle on Masseter Muscle Activity, Pressure Pain Threshold, Active Mouth Opening, Hamstring Flexibility, and Forward Head Flexed Posture in Recreationally Active Participants: A Randomized, Double-Blind, Controlled Trial Study
To assess the immediate effects of hamstring stretching alone or combined with myofascial release of the hamstring muscle on masseter muscle activity, pressure pain threshold, active mouth opening, hamstring flexibility, and forward head flexed posture in recreationally active participants. The young, healthy, recreationally active adults aged 18-25 years were included in the study. The participants were randomly separated into two groups of equal number. Static stretching alone was applied to one group and this was combined with myofascial release techniques (SSMR) for the other group. Masseter muscle activity was assessed using a NORAXON® surface electromyography device. Both pre-and post-intervention, mechanical pressure algometer was used to measure the pressure pain threshold, hamstring flexibility was evaluated using the maximum hip flexion and active knee extension test, the maximum mouth opening (MMO) was measured with the millimetric ruler, and forward flexed posture was evaluated using the tragus to wall distance test.
- Conditions
- Hamstring Injury, Masseter, Myofascial Release, Stretching, Surface EMG, Temporomandibular Joint Disorders
- Being tested
- Static stretching, Myofascial Release
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static stretchingProcedure or surgery
The participant was positioned supine for static stretching to be applied to the hamstring muscles. The physiotherapist flexed the participant's hip to the point where resistance to the movement was first observed, with the knee extended.At this point, after waiting for 40 seconds, it was returned to the previous position. This application was made on both sides [Bretischwerdt]. The technique was repeated three times, with a 15-second rest interval between each repetition.
Myofascial ReleaseProcedure or surgery
For hamstring muscles, the participants were asked to assume a long sitting position on a firm, flat surface with their arms behind their backs and their body weight on their palms. A foam roller was placed under the hamstring muscles and slowly moved the tuberositas ischii popliteus back and forth with pressure for 4 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Surface EMG Data Collection | Other | For each subject, EMG activity was recorded from the left and right superficial masseter muscles using a multichannel EMG device.The EMG recordings were obtained with three repetitions during mandibular rest, and maximal voluntary isometric contractions (MVIC) in intercuspation (isometry) pre and post-treatment. The EMG data were recorded for 5 seconds, and three trials with 30 seconds of rest between contractions were performed [Tosato, SENIAM]. Receives: Procedure: Static stretching; Procedure: Myofascial Release |
| Pressure pain threshold | Other | The pressure pain threshold was measured using a mechanical pressure algometer (model Baseline® Dolorimeters - Fabrication Enterprises Inc) with a contact head of 1 cm2 area. Receives: Procedure: Static stretching; Procedure: Myofascial Release |
| Maximum Active Mouth Opening (MMO) | Other | A tape measure was used to determine the maximum active mouth opening (MMO). Receives: Procedure: Static stretching; Procedure: Myofascial Release |
| Hamstring Flexibility | Other | The Maximal Hip Flexion Active Knee Extension (MHFAKE) Test, which is an adapted active knee extension test, was performed to evaluate the hamstring flexibility of the participant. Receives: Procedure: Static stretching; Procedure: Myofascial Release |
| Tragus Wall Distance | Other | Tragus wall distance measurement was used to evaluate spinal mobility. Receives: Procedure: Static stretching; Procedure: Myofascial Release |
| Static stretching | Experimental | The participant was positioned supine for static stretching to be applied to the hamstring muscles Receives: Procedure: Static stretching |
| Myofascial Release | Experimental | For hamstring muscles, the participants were asked to assume a long sitting position on a firm, flat surface with their arms behind their backs and their body weight on their palms. Receives: Procedure: Myofascial Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
superficial masseter muscles EMG activity
For each subject, EMG activity was recorded from the left and right superficial masseter muscles using a multichannel EMG device.
Measured: 4 weeks
Pressure pain threshold
The pressure pain threshold was measured using a mechanical pressure algometer (model Baseline® Dolorimeters - Fabrication Enterprises Inc) with a contact head of 1 cm2 area.The participant was positioned lying supine while the pressure pain threshold of the masseter muscle's central trigger point was assessed on both sides. Pressure was applied perpendicular to the masseter, gradually and continuously at a rate of about 1 kg/cm/s. The participants were requested to let the examiner know as soon as pain started to be felt. With a 2-min rest period between each experiment, three pressure pain threshold measures were taken. The average value of the three trials was calculated and used in the analysis.
Measured: 4 weeks
Maximum Active Mouth Opening
A tape measure was used to determine the maximum active mouth opening (MMO). The participants were measured while laying flat on their back with the head resting on a table, the cervical spine in a neutral position, the knees slightly bent, and the upper limbs lying parallel to the torso. The subjects were instructed to open the mouth as wide as possible without inflicting discomfort. The distance between the upper and lower central incisors was measured and recorded in millimetres. For the primary analysis, the mean value of three trials was calculated.
Measured: 4 weeks
Hamstring Flexibility
The Maximal Hip Flexion Active Knee Extension (MHFAKE) Test, which is an adapted active knee extension test, was performed to evaluate the hamstring flexibility of the participant. The subject was instructed to keep the hip in maximal flexion by clutching the thigh to the chest, with the hands holding the opposite elbows, and then to actively extend the knee until reaching the point of maximal tolerable stretch of the hamstring muscle or the point where pain was reported. The contralateral leg was fixed by the clinician. The angle of inclination of the mid-shin was measured at the endpoint of maximal stretch with the handheld inclinometer.
Measured: 4 weeks
Tragus Wall Distance
Tragus wall distance measurement was used to evaluate spinal mobility. The participants were instructed to stand with their feet shoulder-width apart, and heels, hips, and shoulders against the wall. Then, before each measurement, the participants were asked to "stand with good posture, look straight ahead, and hold this position until the measurement is taken". The participants were then told to take a self-selected position for the head and neck that reflected their perception of "good posture". The distance between the tragus and the wall was measured and the participant was repositioned away from the wall before each measurement
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start22 Jul 2022
- Primary completion22 Jan 2023
- Study completion20 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hamstring InjuryStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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
- Model description
- This study was designed as a randomized, double-blind, controlled trial. The participants were randomly (randomisation was performed using the website www.randomiser.org ) allocated to one of two groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, caglar soylu, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702593
- Sponsor's protocol ID
- 36442
- Status last verified
- Feb 2023
- First submitted
- 17 Jan 2023
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effects of Hamstring Stretching Alone or Combined With Myofascial Release of the Hamstring Muscle on Masseter Muscle Activity, Pressure Pain Threshold, Active Mouth Opening, Hamstring Flexibility, and Forward Head Flexed Posture in Recreationally Active Participants: A Randomized, Double-Blind, Controlled Trial Study
- ClinicalTrials.gov ID
- NCT05702593
- Acronym / sponsor ID
- 36442
- Conditions
- Hamstring Injury, Masseter, Myofascial Release, Stretching, Surface EMG, Temporomandibular Joint Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 22 Jan 2023 (actual)
- Study completion
- 20 Feb 2023 (estimated)
- First posted
- 27 Jan 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.
To assess the immediate effects of hamstring stretching alone or combined with myofascial release of the hamstring muscle on masseter muscle activity, pressure pain threshold, active mouth opening, hamstring flexibility, and forward head flexed posture in recreationally active participants. The young, healthy, recreationally active adults aged 18-25 years were included in the study. The participants were randomly separated into two groups of equal number. Static stretching alone was applied to one group and this was combined with myofascial release techniques (SSMR) for the other group. Masseter muscle activity was assessed using a NORAXON® surface electromyography device. Both pre-and post-intervention, mechanical pressure algometer was used to measure the pressure pain threshold, hamstring flexibility was evaluated using the maximum hip flexion and active knee extension test, the maximum mouth opening (MMO) was measured with the millimetric ruler, and forward flexed posture was evaluated using the tragus to wall distance test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- This study was designed as a randomized, double-blind, controlled trial. The participants were randomly (randomisation was performed using the website www.randomiser.org ) allocated to one of two groups
| Arm | Type | Receives |
|---|---|---|
| Surface EMG Data Collection | Other | Procedure: Static stretching, Procedure: Myofascial ReleaseFor each subject, EMG activity was recorded from the left and right superficial masseter muscles using a multichannel EMG device.The EMG recordings were obtained with three repetitions during mandibular rest, and maximal voluntary isometric contractions (MVIC) in intercuspation (isometry) pre and post-treatment. The EMG data were recorded for 5 seconds, and three trials with 30 seconds of rest between contractions were performed [Tosato, SENIAM]. |
| Pressure pain threshold | Other | Procedure: Static stretching, Procedure: Myofascial ReleaseThe pressure pain threshold was measured using a mechanical pressure algometer (model Baseline® Dolorimeters - Fabrication Enterprises Inc) with a contact head of 1 cm2 area. |
| Maximum Active Mouth Opening (MMO) | Other | Procedure: Static stretching, Procedure: Myofascial ReleaseA tape measure was used to determine the maximum active mouth opening (MMO). |
| Hamstring Flexibility | Other | Procedure: Static stretching, Procedure: Myofascial ReleaseThe Maximal Hip Flexion Active Knee Extension (MHFAKE) Test, which is an adapted active knee extension test, was performed to evaluate the hamstring flexibility of the participant. |
| Tragus Wall Distance | Other | Procedure: Static stretching, Procedure: Myofascial ReleaseTragus wall distance measurement was used to evaluate spinal mobility. |
| Static stretching | Experimental | Procedure: Static stretchingThe participant was positioned supine for static stretching to be applied to the hamstring muscles |
| Myofascial Release | Experimental | Procedure: Myofascial ReleaseFor hamstring muscles, the participants were asked to assume a long sitting position on a firm, flat surface with their arms behind their backs and their body weight on their palms. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Individuals who had no previous hamstring injury
- Individuals had a Straight Leg Raise test <80°
- Individuals had a pressure-pain threshold difference between two symmetrical points not exceeding 2 kg/cm2
- Individuals who had no previous hamstring injury had no deviation during mouth opening and closing
Key exclusion criteria (3 listed)
- acute low back pain or musculoskeletal pain in the lower extremities
- recent spinal surgery
- previous whiplash injury
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 |
|---|---|---|
| Static stretchingThe participant was positioned supine for static stretching to be applied to the hamstring muscles. The physiotherapist flexed the participant's hip to the point where resistance to the movement was first observed, with the knee extended.At this point, after waiting for 40 seconds, it was returned to the previous position. This application was made on both sides [Bretischwerdt]. The technique was repeated three times, with a 15-second rest interval between each repetition. | Procedure or surgery | Hamstring Flexibility, Maximum Active Mouth Opening (MMO), Pressure pain threshold, Static stretching, Surface EMG Data Collection, Tragus Wall Distance |
| Myofascial ReleaseFor hamstring muscles, the participants were asked to assume a long sitting position on a firm, flat surface with their arms behind their backs and their body weight on their palms. A foam roller was placed under the hamstring muscles and slowly moved the tuberositas ischii popliteus back and forth with pressure for 4 minutes. | Procedure or surgery | Hamstring Flexibility, Maximum Active Mouth Opening (MMO), Myofascial Release, Pressure pain threshold, Surface EMG Data Collection, Tragus Wall Distance |
Primary outcome
superficial masseter muscles EMG activity
Time frame: 4 weeks
For each subject, EMG activity was recorded from the left and right superficial masseter muscles using a multichannel EMG device.
Pressure pain threshold
Time frame: 4 weeks
The pressure pain threshold was measured using a mechanical pressure algometer (model Baseline® Dolorimeters - Fabrication Enterprises Inc) with a contact head of 1 cm2 area.The participant was positioned lying supine while the pressure pain threshold of the masseter muscle's central trigger point was assessed on both sides. Pressure was applied perpendicular to the masseter, gradually and continuously at a rate of about 1 kg/cm/s. The participants were requested to let the examiner know as soon as pain started to be felt. With a 2-min rest period between each experiment, three pressure pain threshold measures were taken. The average value of the three trials was calculated and used in the analysis.
Maximum Active Mouth Opening
Time frame: 4 weeks
A tape measure was used to determine the maximum active mouth opening (MMO). The participants were measured while laying flat on their back with the head resting on a table, the cervical spine in a neutral position, the knees slightly bent, and the upper limbs lying parallel to the torso. The subjects were instructed to open the mouth as wide as possible without inflicting discomfort. The distance between the upper and lower central incisors was measured and recorded in millimetres. For the primary analysis, the mean value of three trials was calculated.
Hamstring Flexibility
Time frame: 4 weeks
The Maximal Hip Flexion Active Knee Extension (MHFAKE) Test, which is an adapted active knee extension test, was performed to evaluate the hamstring flexibility of the participant. The subject was instructed to keep the hip in maximal flexion by clutching the thigh to the chest, with the hands holding the opposite elbows, and then to actively extend the knee until reaching the point of maximal tolerable stretch of the hamstring muscle or the point where pain was reported. The contralateral leg was fixed by the clinician. The angle of inclination of the mid-shin was measured at the endpoint of maximal stretch with the handheld inclinometer.
Tragus Wall Distance
Time frame: 4 weeks
Tragus wall distance measurement was used to evaluate spinal mobility. The participants were instructed to stand with their feet shoulder-width apart, and heels, hips, and shoulders against the wall. Then, before each measurement, the participants were asked to "stand with good posture, look straight ahead, and hold this position until the measurement is taken". The participants were then told to take a self-selected position for the head and neck that reflected their perception of "good posture". The distance between the tragus and the wall was measured and the participant was repositioned away from the wall before each measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static stretching and Myofascial Release in people with Hamstring Injury and Masseter, run by Ankara Yildirim Beyazıt 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 4 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: status not confirmed, as of the sponsor's last update on 9 Feb 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caglar Soylu, PhD (+905078593595, caglar.soylu@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
superficial masseter muscles EMG activity (time frame: 4 weeks). The study lists 5 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 9 Feb 2023.