NCT05702593|UnknownDMC

Immediate Effects of Hamstring Stretching Alone or Combined With Myofascial Release

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

Ankara Yildirim Beyazıt University ClinicalTrials.gov

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1 other identifier

36442

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJan 2023

StartedJul 2022

CompletionFeb 2023

Brief 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. 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

7 months study duration

Study Start

First participant enrolled

July 22, 2022

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2023

Completed

5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2023

Completed

5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed

24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed

Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

January 17, 2023

Last Update Submit

February 8, 2023

Conditions

Hamstring Injury Masseter Myofascial Release Stretching Surface EMG Temporomandibular Joint Disorders

Outcome Measures

Primary Outcomes (5)

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.
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.
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.
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.
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
4 weeks

Study Arms (7)

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 \[Tosato, SENIAM\].