Hamstring FlexibilityNCT05466513
Facial Tactile Stimulation and Hamstring Flexibility
A study testing Facial tactile stimulation in people with Hamstring Flexibility, run by King Saud University.
Trial summary
Inhibition of the sub-occipital muscle group is shown to increase the elasticity of Hamstring muscles. Reversely, stretching of the hamstring muscles is shown to change the pressure pain thresholds over the masseter and upper trapezius muscles. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hamstring Flexibility
- What is being tested?
- Facial tactile stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2013to 13 Mar 2014
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- young healthy adults
Who cannot join
- Musculoskeletal disease that can affect the testing.
About this study
Official title: Effect of Tactile Stimulation of Facial Skin on Hamstring Flexibility in Healthy Young Males
Inhibition of the sub-occipital muscle group is shown to increase the elasticity of Hamstring muscles. Reversely, stretching of the hamstring muscles is shown to change the pressure pain thresholds over the masseter and upper trapezius muscles. There appears to be a functional link between the neuromuscular system of the head and neck and lower extremities. The present study aimed to investigate the effect of tactile stimulation of facial skin on hamstring length in healthy young males. A total of sixty-six participants participated in the study. Hamstring length was measured by the 'Sit and reach' test in long sitting and 'Toe touch' test in standing position before and after two minutes of facial tactile stimulation in the experimental group and rest in the control group.
Read the detailed description
Sixty-six young healthy males in the age range 20-30 years participated in the study. They were free of any musculoskeletal conditions that would affect their performance during the test procedures. Subjects were randomly divided into two groups, the experimental group (EG) and control CG) groups. After each subject was briefed about the objectives and procedure of the experiment, written informed consent was obtained. The study fully complied with the ethical standards for human research of our university review board.
The 'Sit and Reach' (SR) test in long sitting and the 'Toe touch' (TT) test in standing were performed according to previously described protocols. Before the start of each testing session of flexibility tests (SR and TT), subjects were asked to perform about 3-5 minutes of warm-up and standardized static stretching exercises focused on the lower back and hamstring muscles.
For the SR test, a strong cubic wooden box of 35 cm was placed against the wall and each subject sat on the floor mat in a long sitting position. The knees were in full extension and the soles of the shoeless feet in neutral ankle position were placed against the box. Subjects were asked to slowly reach forward towards the toes as far as possible while keeping elbows and fingers fully extended, with palms facing down. The subjects had to maintain this position for about five seconds. The distance (in centimeters) between the tips of the middle finger and a reference point on the wooden box was noted.
For the TT test, subjects had to stand upright on the wooden box with feet at hip-width apart and were instructed to bend slowly to reach towards the toes as far as possible while keeping the knees, elbows, and fingers fully extended, with palms facing backward. The subjects had to maintain this position for about five seconds. Again, the distance (in centimeters) between the tips of the middle finger and a reference point on the floor was noted.
For both the SR and the TT tests, the calculated mean recorded distance between the tips of the middle fingers and the reference point during three trials with two-minute rest intervals in-between was used as a reference value for each subject for subsequent analyzes. These mean values were termed Pretest-SR and Pretest TT, respectively. Following the baseline assessment value of the SR and TT tests, each subject of CG or EG underwent three additional trials for each test, with a two-minute interval in between the trials. SR and TT tests were performed randomly without any specific order for both groups of subjects at the same time of day and room temperature. During the two-minute interval, the CG subjects spent their time resting in the supine position with closed eyes, while the EG subjects received tactile stimulation on the facial skin in the supine position with closed eyes. The tactile stimulation to the facial skin of the EG subjects was given by one of the authors and consisted of random strokes similar to a paintbrush around the face with soft tissue paper for two minutes.
For each subject of the CG and EG, the mean distance values between the tips of the middle fingers and the reference point during three trials during the SR and TT tests were calculated, respectively. These mean values were termed Post-test-SR and Post-test-TT, respectively. For all subjects of both the CG and EG, the difference between the Post-test-SR and Pre-test-SR; and Pre-test-TT and Pre-test-TT mean values were calculated. A greater difference between the Post-test-SR and Pre-test-SR; and the Post-test-TT and Pre-test-TT mean values were considered as increased flexibility of the hamstring muscles.
- Conditions
- Hamstring Flexibility
- Being tested
- Facial tactile stimulation
- Keywords
- Facial skin, hamstring muscle flexibility, tactile Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial tactile stimulationOther
Tactile stimulation was given around the face with soft tissue paper for two minutes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Facial tactile stimulation was applied for 2 minutes. Receives: Other: Facial tactile stimulation |
| Control Group | No intervention | No intervention was applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamstring flexibility
Hamstring muscle length was measured by Sit and reach test and Toe-touch test.
Measured: 2 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start10 Oct 2013
- Primary completion21 Jan 2014
- Study completion13 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hamstring FlexibilityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms parallel (Experimental and control group) design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masood Khan, King Saud University
- Investigators
- Masood Khan, M.P.Th, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466513
- Sponsor's protocol ID
- RRC-2013-013
- Status last verified
- Jul 2022
- First submitted
- 17 Jul 2022
- Last updated
- 22 Jul 2022
- 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 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tactile Stimulation of Facial Skin on Hamstring Flexibility in Healthy Young Males
- ClinicalTrials.gov ID
- NCT05466513
- Acronym / sponsor ID
- RRC-2013-013
- Conditions
- Hamstring Flexibility
- Keywords
- Facial skin, hamstring muscle flexibility, tactile Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 10 Oct 2013 (actual)
- Primary completion
- 21 Jan 2014 (actual)
- Study completion
- 13 Mar 2014 (actual)
- First posted
- 20 Jul 2022 (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.
Inhibition of the sub-occipital muscle group is shown to increase the elasticity of Hamstring muscles. Reversely, stretching of the hamstring muscles is shown to change the pressure pain thresholds over the masseter and upper trapezius muscles. There appears to be a functional link between the neuromuscular system of the head and neck and lower extremities. The present study aimed to investigate the effect of tactile stimulation of facial skin on hamstring length in healthy young males. A total of sixty-six participants participated in the study. Hamstring length was measured by the 'Sit and reach' test in long sitting and 'Toe touch' test in standing position before and after two minutes of facial tactile stimulation in the experimental group and rest in the control group.
Detailed description
Sixty-six young healthy males in the age range 20-30 years participated in the study. They were free of any musculoskeletal conditions that would affect their performance during the test procedures. Subjects were randomly divided into two groups, the experimental group (EG) and control CG) groups. After each subject was briefed about the objectives and procedure of the experiment, written informed consent was obtained. The study fully complied with the ethical standards for human research of our university review board.
The 'Sit and Reach' (SR) test in long sitting and the 'Toe touch' (TT) test in standing were performed according to previously described protocols. Before the start of each testing session of flexibility tests (SR and TT), subjects were asked to perform about 3-5 minutes of warm-up and standardized static stretching exercises focused on the lower back and hamstring muscles.
For the SR test, a strong cubic wooden box of 35 cm was placed against the wall and each subject sat on the floor mat in a long sitting position. The knees were in full extension and the soles of the shoeless feet in neutral ankle position were placed against the box. Subjects were asked to slowly reach forward towards the toes as far as possible while keeping elbows and fingers fully extended, with palms facing down. The subjects had to maintain this position for about five seconds. The distance (in centimeters) between the tips of the middle finger and a reference point on the wooden box was noted.
For the TT test, subjects had to stand upright on the wooden box with feet at hip-width apart and were instructed to bend slowly to reach towards the toes as far as possible while keeping the knees, elbows, and fingers fully extended, with palms facing backward. The subjects had to maintain this position for about five seconds. Again, the distance (in centimeters) between the tips of the middle finger and a reference point on the floor was noted.
For both the SR and the TT tests, the calculated mean recorded distance between the tips of the middle fingers and the reference point during three trials with two-minute rest intervals in-between was used as a reference value for each subject for subsequent analyzes. These mean values were termed Pretest-SR and Pretest TT, respectively. Following the baseline assessment value of the SR and TT tests, each subject of CG or EG underwent three additional trials for each test, with a two-minute interval in between the trials. SR and TT tests were performed randomly without any specific order for both groups of subjects at the same time of day and room temperature. During the two-minute interval, the CG subjects spent their time resting in the supine position with closed eyes, while the EG subjects received tactile stimulation on the facial skin in the supine position with closed eyes. The tactile stimulation to the facial skin of the EG subjects was given by one of the authors and consisted of random strokes similar to a paintbrush around the face with soft tissue paper for two minutes.
For each subject of the CG and EG, the mean distance values between the tips of the middle fingers and the reference point during three trials during the SR and TT tests were calculated, respectively. These mean values were termed Post-test-SR and Post-test-TT, respectively. For all subjects of both the CG and EG, the difference between the Post-test-SR and Pre-test-SR; and Pre-test-TT and Pre-test-TT mean values were calculated. A greater difference between the Post-test-SR and Pre-test-SR; and the Post-test-TT and Pre-test-TT mean values were considered as increased flexibility of the hamstring muscles.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two arms parallel (Experimental and control group) design.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Facial tactile stimulationFacial tactile stimulation was applied for 2 minutes. |
| Control Group | No intervention | –No intervention was applied. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- young healthy adults
Key exclusion criteria (1 listed)
- Musculoskeletal disease that can affect the testing.
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 |
|---|---|---|
| Facial tactile stimulationTactile stimulation was given around the face with soft tissue paper for two minutes. | Other | Experimental Group |
Primary outcome
Hamstring flexibility
Time frame: 2 minutes.
Hamstring muscle length was measured by Sit and reach test and Toe-touch test.
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 22 Jul 2022.
- 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.
Masood Khan, M.P.Th principal investigator
King Saud University
Questions about this trial
What is this clinical trial studying?
A study testing Facial tactile stimulation in people with Hamstring Flexibility, run by King Saud University.
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 1 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 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Hamstring flexibility (time frame: 2 minutes.). 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 22 Jul 2022.