HealthyNCT03958084
Effect of Therapeutic Techniques on Leg Stretching in Healthy Subjects
A study testing Straight Leg Raise in people with Healthy and Adult, run by Alessandro Haupenthal at 1 site in Brazil.
Trial summary
There are physiotherapy techniques, known as lumbar mobilization, proprioceptive neuromuscular facilitation, massage therapy, windsheets and foam roller that present good results in stretching the legs. This study aims to evaluate which of these techniques has a better result in leg stretching. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- What is being tested?
- Straight Leg Raise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jul 2020to 30 Mar 2021
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 35 years of age.
- No pain in the posterior thigh.
Who cannot join
- Volunteers who present deep venous thrombosis.
- Cutaneous allergy.
- Cutaneous lesion.
- Posterior thigh edema.
- Lower limb prosthesis.
- Shoulder or wrist injuries.
Show all 15Show fewer
- Phobia of the techniques.
- Scarring in the posterior region of the thigh
- Have performed myofacial release or stretches during the days of intervention.
- Pilates and yoga practitioners
- No attend every day intervention.
- Injury of hamstrings in the last year.
- Previous injuries to the spine or lower limbs in the last 6 months.
- Symptoms of low back pain or hip joint.
- Diabetes mellitus, since people with diabetes have limited responses in the elevated leg elevation test.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Santa Catarina Federal University
Araranguá, Santa Catarina, 88.906-072
Alessandro Haupenthal, Doctorate, 55 48 999028190, dedsnet@yahoo.com.br
Cassia Rodrigues Schuster, Student, 55 48 996390975, cassiarschuster@hotmail.com
About this study
Official title: Effect of Different Therapeutic Techniques on the Flexibility of ischiotíbial in Healthy Individuals
There are physiotherapy techniques, known as lumbar mobilization, proprioceptive neuromuscular facilitation, massage therapy, windsheets and foam roller that present good results in stretching the legs. This study aims to evaluate which of these techniques has a better result in leg stretching. It is believed that massage therapy and lumbar mobilization will provide better results.
Read the detailed description
A randomized clinical trial blind crossover. The aim of this study is comparing the immediate effect of five interventions on the flexibility of hamstrings in healthy individuals. Participants will be assessed pre and post intervention through the extended leg elevation test and photogrammetry. The techniques of unilateral lumbar mobilization, proprioceptive neuromuscular facilitation, massage, ventosa therapy and foam roller will be applied on different days with a 48-hour interval between interventions. The techniques will be compared using the repeated measures ANOVA after verification of normality by the Shapiro-Wilk test, adopting the significance level of 5% and 95% confidence interval.
- Being tested
- Straight Leg Raise
- Keywords
- Lower Extremity, Musculoskeletal Manipulations, Range of motion, Hamstring Muscles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Straight Leg RaiseDiagnostic test
The assessment of the flexibility of the hamstring will be realized through the test of straight leg raise (SLR). The SLR is a passive test performed unilaterally.
| Study group | Role | What they receive |
|---|---|---|
| Massage group | Experimental | The deep massage will be applied for three minutes in the ischiotíbial muscles, only in the left limb, towards the muscular fibers. The volunteers will be placed in a ventral decubitus position on the stretcher. Receives: Diagnostic Test: Straight Leg Raise |
| Ventosa therapy group | Experimental | The negative pressure ventosa therapy slide winds will be applied for three minutes in the oval direction in the posterior region of the thigh to contemplate the full extent of the ischiotíbial muscles, only in the left limb. The volunteers will be placed in a ventral decubitus position on the stretcher. Receives: Diagnostic Test: Straight Leg Raise |
| Foam roller group | Experimental | The foam roller is a self-applied intervention for three minutes where the volunteers will be positioned on bench press on the floor of the room, with the left thigh posteriorly on the foam roller and the leg extended, the right lower limb will be in flexion of hip and knee, only the right foot and the right and left hands will touch the ground. Volunteers will be instructed to move so that they move forward and backward, causing the roller to travel the full length of the hamstring muscles. Receives: Diagnostic Test: Straight Leg Raise |
| Lumbar mobilization group | Experimental | Unilateral lumbar mobilization of grade III at the frequency of 2Hz at the joint L4 / L5 of the ipsilateral side of the limb tested. The frequency was guaranteed by a metronome set at 120 beats per minute. Three sets of 1 minute of mobilization were performed with a 30 second interval, totaling a time of 4 minutes and 30 seconds of intervention. The technique was performed with the patient in the ventral decubitus position. Receives: Diagnostic Test: Straight Leg Raise |
| Proprioceptive neuromuscular facilitation group | Experimental | Patient in dorsal decubitus, the examiner lifted the participant's leg up to the referred maximum amplitude. He then asked the patient for an isometric contraction of the hamstring muscles against the researcher's resistance for 10 seconds. After contraction, the researcher asked the patient to relax for 10 seconds. Then the member is repositioned passively by the researcher until the new amplitude limit reached. The technique was performed in 2 sets of 4 repetitions with an interval of 1 minute, totaling in an approximate time of 4 minutes of intervention. Receives: Diagnostic Test: Straight Leg Raise |
| Control group | No intervention | The patient remained lying down in the ventral position for 4 minutes. the patient remained lying down in the ventral position for 4 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
The study has as main variable the range of motion of the hamstrings measured in degrees, through the test of the Elevation of the Extended Leg. The amplitude reached in the pre- and post-test was recorded by means of a photogrammetry and analyzed by a free postural evaluation program that provides the researcher with calculating linear and angular measurements through spatially defined anatomical points.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start20 Jul 2020 (estimated)
- Primary completion15 Dec 2020 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alessandro Haupenthal
- Sponsor type
- University, hospital or other
- Collaborators
- Santa Catarina Federal University
- Responsible party
- Sponsor-investigator, Alessandro Haupenthal, Universidade Federal de Santa Catarina
- Investigators
- Alessandro Haupenthal, Teacher, Principal investigator, Santa Catarina Federal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958084
- Sponsor's protocol ID
- 1;771;454
- Status last verified
- Apr 2020
- First submitted
- 17 May 2019
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
AGOSTINHO, A. et al. Vacuoterapia: influência no aumento da flexibilidade muscular dos isquiotíbiais. Saúde & Tecnologia .16, p.38-43, 2016.
CASSAR, Paul Mario. Manual de massagem terapêutica : um guia completo de massoterapia para o estudante e para o terapeuta. São Paulo: Manole, 1ª ed, p.231, 2001.
Mohr AR, Long BC, Goad CL. Effect of foam rolling and static stretching on passive hip-flexion range of motion. J Sport Rehabil. 2014 Nov;23(4):296-9. doi: 10.1123/jsr.2013-0025. Epub 2014 Jan 21.
PubMed 24458506CHESTERTON et al. The Effect of Mobilising the Lumbar 4/5 Zygapophyseal Joint on Hamstring Extensibility in Elite Soccer Players. International Journal of Physiotherapy and Rehabilitation, 2016;
Puentedura EJ, Huijbregts PA, Celeste S, Edwards D, In A, Landers MR, Fernandez-de-Las-Penas C. Immediate effects of quantified hamstring stretching: hold-relax proprioceptive neuromuscular facilitation versus static stretching. Phys Ther Sport. 2011 Aug;12(3):122-6. doi: 10.1016/j.ptsp.2011.02.006. Epub 2011 Apr 15.
PubMed 21802038Shankar Ganesh G, Mohanty P, Smita Pattnaik S. The immediate and 24-hour follow-up effect of unilateral lumbar Z-joint mobilisation on posterior chain neurodynamics. J Bodyw Mov Ther. 2015 Apr;19(2):226-31. doi: 10.1016/j.jbmt.2014.04.009. Epub 2014 Apr 18.
PubMed 25892376Boyd BS, Wanek L, Gray AT, Topp KS. Mechanosensitivity of the lower extremity nervous system during straight-leg raise neurodynamic testing in healthy individuals. J Orthop Sports Phys Ther. 2009 Nov;39(11):780-90. doi: 10.2519/jospt.2009.3002.
PubMed 19881004
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Therapeutic Techniques on the Flexibility of ischiotíbial in Healthy Individuals
- ClinicalTrials.gov ID
- NCT03958084
- Acronym / sponsor ID
- 1;771;454
- Keywords
- Lower Extremity, Musculoskeletal Manipulations, Range of motion, Hamstring Muscles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alessandro HaupenthalUniversity, hospital or other
- Collaborators
- Santa Catarina Federal University
- Study start
- 20 Jul 2020 (estimated)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 21 May 2019 (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.
There are physiotherapy techniques, known as lumbar mobilization, proprioceptive neuromuscular facilitation, massage therapy, windsheets and foam roller that present good results in stretching the legs. This study aims to evaluate which of these techniques has a better result in leg stretching. It is believed that massage therapy and lumbar mobilization will provide better results.
Detailed description
A randomized clinical trial blind crossover. The aim of this study is comparing the immediate effect of five interventions on the flexibility of hamstrings in healthy individuals. Participants will be assessed pre and post intervention through the extended leg elevation test and photogrammetry. The techniques of unilateral lumbar mobilization, proprioceptive neuromuscular facilitation, massage, ventosa therapy and foam roller will be applied on different days with a 48-hour interval between interventions. The techniques will be compared using the repeated measures ANOVA after verification of normality by the Shapiro-Wilk test, adopting the significance level of 5% and 95% confidence interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Massage group | Experimental | Diagnostic Test: Straight Leg RaiseThe deep massage will be applied for three minutes in the ischiotíbial muscles, only in the left limb, towards the muscular fibers. The volunteers will be placed in a ventral decubitus position on the stretcher. |
| Ventosa therapy group | Experimental | Diagnostic Test: Straight Leg RaiseThe negative pressure ventosa therapy slide winds will be applied for three minutes in the oval direction in the posterior region of the thigh to contemplate the full extent of the ischiotíbial muscles, only in the left limb. The volunteers will be placed in a ventral decubitus position on the stretcher. |
| Foam roller group | Experimental | Diagnostic Test: Straight Leg RaiseThe foam roller is a self-applied intervention for three minutes where the volunteers will be positioned on bench press on the floor of the room, with the left thigh posteriorly on the foam roller and the leg extended, the right lower limb will be in flexion of hip and knee, only the right foot and the right and left hands will touch the ground. Volunteers will be instructed to move so that they move forward and backward, causing the roller to travel the full length of the hamstring muscles. |
| Lumbar mobilization group | Experimental | Diagnostic Test: Straight Leg RaiseUnilateral lumbar mobilization of grade III at the frequency of 2Hz at the joint L4 / L5 of the ipsilateral side of the limb tested. The frequency was guaranteed by a metronome set at 120 beats per minute. Three sets of 1 minute of mobilization were performed with a 30 second interval, totaling a time of 4 minutes and 30 seconds of intervention. The technique was performed with the patient in the ventral decubitus position. |
| Proprioceptive neuromuscular facilitation group | Experimental | Diagnostic Test: Straight Leg RaisePatient in dorsal decubitus, the examiner lifted the participant's leg up to the referred maximum amplitude. He then asked the patient for an isometric contraction of the hamstring muscles against the researcher's resistance for 10 seconds. After contraction, the researcher asked the patient to relax for 10 seconds. Then the member is repositioned passively by the researcher until the new amplitude limit reached. The technique was performed in 2 sets of 4 repetitions with an interval of 1 minute, totaling in an approximate time of 4 minutes of intervention. |
| Control group | No intervention | –The patient remained lying down in the ventral position for 4 minutes. the patient remained lying down in the ventral position for 4 minutes. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 to 35 years of age.
- No pain in the posterior thigh.
Key exclusion criteria (15 listed)
- Volunteers who present deep venous thrombosis.
- Cutaneous allergy.
- Cutaneous lesion.
- Posterior thigh edema.
- Lower limb prosthesis.
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 |
|---|---|---|
| Straight Leg RaiseThe assessment of the flexibility of the hamstring will be realized through the test of straight leg raise (SLR). The SLR is a passive test performed unilaterally. | Diagnostic test | Foam roller group, Lumbar mobilization group, Massage group, Proprioceptive neuromuscular facilitation group, Ventosa therapy group |
Primary outcome
Range of motion
Time frame: 10 minutes
The study has as main variable the range of motion of the hamstrings measured in degrees, through the test of the Elevation of the Extended Leg. The amplitude reached in the pre- and post-test was recorded by means of a photogrammetry and analyzed by a free postural evaluation program that provides the researcher with calculating linear and angular measurements through spatially defined anatomical points.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- BackgroundAGOSTINHO, A. et al. Vacuoterapia: influência no aumento da flexibilidade muscular dos isquiotíbiais. Saúde & Tecnologia .16, p.38-43, 2016.
- BackgroundCASSAR, Paul Mario. Manual de massagem terapêutica : um guia completo de massoterapia para o estudante e para o terapeuta. São Paulo: Manole, 1ª ed, p.231, 2001.
- Background: PubMed 24458506Mohr AR, Long BC, Goad CL. Effect of foam rolling and static stretching on passive hip-flexion range of motion. J Sport Rehabil. 2014 Nov;23(4):296-9. doi: 10.1123/jsr.2013-0025. Epub 2014 Jan 21.
- BackgroundCHESTERTON et al. The Effect of Mobilising the Lumbar 4/5 Zygapophyseal Joint on Hamstring Extensibility in Elite Soccer Players. International Journal of Physiotherapy and Rehabilitation, 2016;
- Background: PubMed 21802038Puentedura EJ, Huijbregts PA, Celeste S, Edwards D, In A, Landers MR, Fernandez-de-Las-Penas C. Immediate effects of quantified hamstring stretching: hold-relax proprioceptive neuromuscular facilitation versus static stretching. Phys Ther Sport. 2011 Aug;12(3):122-6. doi: 10.1016/j.ptsp.2011.02.006. Epub 2011 Apr 15.
- Background: PubMed 25892376Shankar Ganesh G, Mohanty P, Smita Pattnaik S. The immediate and 24-hour follow-up effect of unilateral lumbar Z-joint mobilisation on posterior chain neurodynamics. J Bodyw Mov Ther. 2015 Apr;19(2):226-31. doi: 10.1016/j.jbmt.2014.04.009. Epub 2014 Apr 18.
- Background: PubMed 19881004Boyd BS, Wanek L, Gray AT, Topp KS. Mechanosensitivity of the lower extremity nervous system during straight-leg raise neurodynamic testing in healthy individuals. J Orthop Sports Phys Ther. 2009 Nov;39(11):780-90. doi: 10.2519/jospt.2009.3002.
- 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.
Alessandro Haupenthal, Teacher principal investigator
Santa Catarina Federal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Straight Leg Raise in people with Healthy and Adult, run by Alessandro Haupenthal at 1 site in Brazil.
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 2 inclusion and 15 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 24 Apr 2020. 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 Brazil. 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 Alessandro Haupenthal, Teacher (55(48)99028190, alessandro.haupenthal@ufsc.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (time frame: 10 minutes). 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 NCT03958084, which also lists 7 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 24 Apr 2020.