AzTrials
AzTrials

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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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.

Caglar Soylu, PhD contact

+905078593595

caglar.soylu@sbu.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Caglar Soylu

    Ankara, Keçiören, 06010

    Recruiting

Other trials in Turkey (Türkiye)

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.

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 groups in NCT05702593
Study groupRoleWhat they receive
Surface EMG Data CollectionOtherFor 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 thresholdOtherThe 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)OtherA tape measure was used to determine the maximum active mouth opening (MMO).
Receives: Procedure: Static stretching; Procedure: Myofascial Release
Hamstring FlexibilityOtherThe 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 DistanceOtherTragus wall distance measurement was used to evaluate spinal mobility.
Receives: Procedure: Static stretching; Procedure: Myofascial Release
Static stretchingExperimentalThe participant was positioned supine for static stretching to be applied to the hamstring muscles
Receives: Procedure: Static stretching
Myofascial ReleaseExperimentalFor 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted27 Jan 2023
  2. Study start22 Jul 2022
  3. Primary completion22 Jan 2023
  4. Study completion20 Feb 2023 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in