Hamstring InjuryREFEMNCT06188897
Biomechanical Relationship Between Trunk Flexion and Mouth Opening: Pilot Study
A study testing Self-stretching of the masticatory musculature in people with Hamstring Injury and Temporomandibular Joint Disorders, run by University Rovira i Virgili at 1 site in Spain.
Trial summary
The aim of the present study is to analyze if there is a biomechanical relationship between trunk flexion and buccal opening and to observe if there is an improvement of trunk flexion by performing the "sit and reach" test when stretching the masticatory muscles. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Hamstring Injury, Temporomandibular Joint Disorders, Stretch
- What is being tested?
- Self-stretching of the masticatory musculature
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2023to 15 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 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between 18 and 26 years old (both included).
- Having signed the consent form.
- Being able to introduce three knuckles of the non-dominant hand between the incisors.
Who cannot join
- Having a musculoskeletal injury in the lower extremity and / or in the jaw.
- Being in the process of receiving physiotherapy treatment and / or having undergone any odontologic or maxillofacial surgery in the last month.
- Having suffered dislocations, painful clicks or being diagnosed with some type of temporomandibular joint (TMJ) dysfunction.
- Having hypermobility in the temporomandibular joint (TMJ) that is, the measurement of the buccal opening being greater than 60 mm.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the present study is to analyze if there is a biomechanical relationship between trunk flexion and buccal opening and to observe if there is an improvement of trunk flexion by performing the "sit and reach" test when stretching the masticatory muscles.
Read the detailed description
The study design is made up of a double-blind clinical trial with 60 participants randomly divided into two groups of 30 people each (Treatment group and Control group). Basal measurements of the mouth opening were taken with a vernier caliper and the trunk flexion measurements were taken by means of the "sit and reach" test. These measurements were carried out again after the intervention, which consisted of self-stretching of the masticatory muscles for the Treatment group and an occlusion of the mouth for the Control group. In the results there was an increase in the trunk flexion compared to the initial values in both groups (Treatment group 2.8 (1.51), Control group 1.97 (2.31) and this increase was greater in the Treatment group even though the difference with the Control group was not statistically significant. Therefore, the stretching of the masticatory muscles does not cause an immediate increase in the degree of trunk flexion measured by the "sit and reach" test. As a consequence, we cannot confirm the existence of a biomechanical relationship between trunk flexion and mouth opening.
- Conditions
- Hamstring Injury, Temporomandibular Joint Disorders, Stretch
- Being tested
- Self-stretching of the masticatory musculature, Control group intervention
- 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.
Self-stretching of the masticatory musculatureOther
If the subject belonged to the Treatment group, he was instructed to self-stretch the masticatory muscle.
This stretch consisted of introducing three knuckles of the non-dominant hand between the incisors for two minutes while sitting.
Control group interventionOther
The control group was asked to introduce only two knuckles in the oral cavity and perform a mandibular occlusion, an intervention that serves as a simulated stretch in said group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group did the intervention, which consisted of self-stretching of the masticatory muscles. This stretch consisted of introducing three knuckles of the non-dominant hand between the incisors for two minutes while sitting Receives: Other: Self-stretching of the masticatory musculature |
| Control group | Placebo comparator | The control group was asked to introduce only two knuckles in the oral cavity and perform a mandibular occlusion, an intervention that serves as a simulated stretch in said group. Receives: Other: Control group intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk flexion
Trunk flexion in cm, taken by using the "sit and reach" drawer (Eve-que). The measurements were made three consecutive times with an interval of five seconds between them. The result of the arithmetic average of the three measurements was the one that was accounted for in the study. For the measurement of trunk flexion, the subject was placed on the floor with his back against the wall and having the soles of both feet in contact with the drawer.
Measured: 1 year
Secondary outcomes (1)
Mandibular opening
Mandibular opening in mm., assessed using the vernier caliper (INCUTEX Germany GmbHl). The measurement was made three consecutive times with an interval of five seconds between them. The result of the arithmetic average of the three measurements was the one that was caliper (corresponding to 0 of the ruler) was placed at the upper end of the lower central incisors and measured to the edge of the corresponding central incisor.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Feb 2023
- Primary completion2 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hamstring InjuryStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Menés Fernández, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188897
- Sponsor's protocol ID
- 23/2016
- Acronym
- REFEM
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Espejo-Antunez L, Castro-Valenzuela E, Ribeiro F, Albornoz-Cabello M, Silva A, Rodriguez-Mansilla J. Immediate effects of hamstring stretching alone or combined with ischemic compression of the masseter muscle on hamstrings extensibility, active mouth opening and pain in athletes with temporomandibular dysfunction. J Bodyw Mov Ther. 2016 Jul;20(3):579-87. doi: 10.1016/j.jbmt.2015.12.012. Epub 2016 Jan 7.
PubMed 27634081Rodriguez-Blanco C, Cocera-Morata FM, Heredia-Rizo AM, Ricard F, Almazan-Campos G, Oliva-Pascual-Vaca A. Immediate Effects of Combining Local Techniques in the Craniomandibular Area and Hamstring Muscle Stretching in Subjects with Temporomandibular Disorders: A Randomized Controlled Study. J Altern Complement Med. 2015 Aug;21(8):451-9. doi: 10.1089/acm.2014.0332. Epub 2015 Jun 2.
PubMed 26218883
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Relationship Between Trunk Flexion and Mouth Opening: Pilot Study
- ClinicalTrials.gov ID
- NCT06188897
- Acronym / sponsor ID
- REFEM / 23/2016
- Conditions
- Hamstring Injury, Temporomandibular Joint Disorders, Stretch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 3 Jan 2024 (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 present study is to analyze if there is a biomechanical relationship between trunk flexion and buccal opening and to observe if there is an improvement of trunk flexion by performing the "sit and reach" test when stretching the masticatory muscles.
Detailed description
The study design is made up of a double-blind clinical trial with 60 participants randomly divided into two groups of 30 people each (Treatment group and Control group). Basal measurements of the mouth opening were taken with a vernier caliper and the trunk flexion measurements were taken by means of the "sit and reach" test. These measurements were carried out again after the intervention, which consisted of self-stretching of the masticatory muscles for the Treatment group and an occlusion of the mouth for the Control group. In the results there was an increase in the trunk flexion compared to the initial values in both groups (Treatment group 2.8 (1.51), Control group 1.97 (2.31) and this increase was greater in the Treatment group even though the difference with the Control group was not statistically significant. Therefore, the stretching of the masticatory muscles does not cause an immediate increase in the degree of trunk flexion measured by the "sit and reach" test. As a consequence, we cannot confirm the existence of a biomechanical relationship between trunk flexion and mouth opening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Self-stretching of the masticatory musculatureThe experimental group did the intervention, which consisted of self-stretching of the masticatory muscles. This stretch consisted of introducing three knuckles of the non-dominant hand between the incisors for two minutes while sitting |
| Control group | Placebo comparator | Other: Control group interventionThe control group was asked to introduce only two knuckles in the oral cavity and perform a mandibular occlusion, an intervention that serves as a simulated stretch in said group. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being between 18 and 26 years old (both included).
- Having signed the consent form.
- Being able to introduce three knuckles of the non-dominant hand between the incisors.
Key exclusion criteria (4 listed)
- Having a musculoskeletal injury in the lower extremity and / or in the jaw.
- Being in the process of receiving physiotherapy treatment and / or having undergone any odontologic or maxillofacial surgery in the last month.
- Having suffered dislocations, painful clicks or being diagnosed with some type of temporomandibular joint (TMJ) dysfunction.
- Having hypermobility in the temporomandibular joint (TMJ) that is, the measurement of the buccal opening being greater than 60 mm.
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-stretching of the masticatory musculatureIf the subject belonged to the Treatment group, he was instructed to self-stretch the masticatory muscle. This stretch consisted of introducing three knuckles of the non-dominant hand between the incisors for two minutes while sitting. | Other | Experimental group |
| Control group interventionThe control group was asked to introduce only two knuckles in the oral cavity and perform a mandibular occlusion, an intervention that serves as a simulated stretch in said group. | Other | Control group |
Primary outcome
Trunk flexion
Time frame: 1 year
Trunk flexion in cm, taken by using the "sit and reach" drawer (Eve-que). The measurements were made three consecutive times with an interval of five seconds between them. The result of the arithmetic average of the three measurements was the one that was accounted for in the study. For the measurement of trunk flexion, the subject was placed on the floor with his back against the wall and having the soles of both feet in contact with the drawer.
1 secondary outcome
Mandibular opening
Time frame: 1 year
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 3 Jan 2024.
- Background: PubMed 27634081Espejo-Antunez L, Castro-Valenzuela E, Ribeiro F, Albornoz-Cabello M, Silva A, Rodriguez-Mansilla J. Immediate effects of hamstring stretching alone or combined with ischemic compression of the masseter muscle on hamstrings extensibility, active mouth opening and pain in athletes with temporomandibular dysfunction. J Bodyw Mov Ther. 2016 Jul;20(3):579-87. doi: 10.1016/j.jbmt.2015.12.012. Epub 2016 Jan 7.
- Background: PubMed 26218883Rodriguez-Blanco C, Cocera-Morata FM, Heredia-Rizo AM, Ricard F, Almazan-Campos G, Oliva-Pascual-Vaca A. Immediate Effects of Combining Local Techniques in the Craniomandibular Area and Hamstring Muscle Stretching in Subjects with Temporomandibular Disorders: A Randomized Controlled Study. J Altern Complement Med. 2015 Aug;21(8):451-9. doi: 10.1089/acm.2014.0332. Epub 2015 Jun 2.
- Individual participant dataSharing planned: No
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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.
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 Self-stretching of the masticatory musculature in people with Hamstring Injury and Temporomandibular Joint Disorders, run by University Rovira i Virgili 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 3 inclusion and 4 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 3 Jan 2024. 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. Some participants in this study may receive a placebo. 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?
Trunk flexion (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06188897, which also lists 2 linked publications.
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 3 Jan 2024.