Hamstring InjuryNCT04345055
Immediate Impact of Lumbar Fascia Stretching on Hamstring Flexibility
A study testing Treatment of the lumbar fasciae in people with Hamstring Injury, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Introduction: the hamstring muscles has a great tendency to decrease its extensibility, originating a pathology with a own clinical entity, the Short Hamstring Syndrome (SHS), in addition to other problems on adjacent structures. All this present a great socioeconomic impact in the investigator's society. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hamstring Injury
- What is being tested?
- Treatment of the lumbar fasciae
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2019to 30 Apr 2019
- 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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female between 18 and 39 years old.
- Signed informed consent
Who cannot join
- Any alteration that prevents the normal communication between the patient and the therapist at the time of the study.
- Have an injury in the hamstring muscles.
- Have a chronic or acute lumbar pain in the moment of the realization.
- Neurological or orthopedic desease.
- Any important estructural alteration in the lower members that may be likely to alter the results under study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Impact of Lumbar Fascia Stretching on Hamstring Flexibility: a Randomized Clinical Trial
Introduction: the hamstring muscles has a great tendency to decrease its extensibility, originating a pathology with a own clinical entity, the Short Hamstring Syndrome (SHS), in addition to other problems on adjacent structures. All this present a great socioeconomic impact in the investigator's society. Various techniques have been demostrated to prduce an increase in flexibility, among which are the fascial techniques.
Objective: to evaluate the immediate efficacy of the treatment of the lumbar fascia in the flexibility of the hamstring musculature.
Methods: 41 women between 18 and 39 years old, in two groups. The experimental group received a technique of fascial stretching in the lumbar area while the control group participated in an off magnetotherapy machine. The hamstring flexibility in both lower limbs was measured by the Straight Leg Raising Test (SLR) and the Passive Popliteal Angle Test (PKE).
Read the detailed description
The hamstring muscles has a great tendency to decrease its extensibility, originating a pathology with a own clinical entity, the Short Hamstring Syndrome (SHS), in addition to other problems on adjacent structures. This study aims to help improve treatment for the problem mentioned before, which can be included within a therapeutic framework to combat SHS. In recent years, investigations have been carried out that include different techniques for stretching the hamstring muscles, as well as the treatment of other structures belonging to the posterior superficial chain. Within this last section, myofascial stretching techniques have been shown to be effective both in the short and medium term. Different techniques for stretching the hamstring muscles have been carried out with the aim of increasing the flexibility of the lower back in general.
he objective is to evaluate the immediate efficacy of the treatment of the lumbar fascia in the flexibility of the hamstring musculature.
The participants are 41 women between 18 and 39 years old, in two groups. The experimental group received a technique of fascial stretching in the lumbar area while the control group participated in an off magnetotherapy machine. The hamstring flexibility in both lower limbs was measured by the Straight Leg Raising Test (SLR) and the Passive Popliteal Angle Test (PKE).
- Conditions
- Hamstring Injury
- Being tested
- Treatment of the lumbar fasciae, Placebo intervention
- Keywords
- hamstring muscles, lumbar fascia, flexibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of the lumbar fasciaeOther
Treat the lumbar facial with a manual technique
Placebo interventionOther
Introduce in a machine off
| Study group | Role | What they receive |
|---|---|---|
| Fascial treatment | Experimental | Treatment the lumbar fasciae Receives: Other: Treatment of the lumbar fasciae |
| Placebo group | Placebo comparator | Introduce in a machine off Receives: Other: Placebo intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Straight Leg Raising Test (SLR)
Test
Measured: Pre-intervention and immediately after the intervention
Change from Passive Popliteal Angle Test (PKE)
Test
Measured: Pre-intervention and immediately after the intervention
Secondary outcomes (1)
IPAQ
Cuestionnary
Measured: Pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 Mar 2019
- Primary completion1 Mar 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Perez Cruzado, Universidad Católica San Antonio de Murcia
- Investigators
- Juan Javier Bru Ruiz, Principal investigator, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345055
- Sponsor's protocol ID
- CONSORT
- Status last verified
- Apr 2020
- First submitted
- 6 Apr 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Impact of Lumbar Fascia Stretching on Hamstring Flexibility: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04345055
- Acronym / sponsor ID
- CONSORT
- Conditions
- Hamstring Injury
- Keywords
- hamstring muscles, lumbar fascia, flexibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 14 Apr 2020 (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.
Introduction: the hamstring muscles has a great tendency to decrease its extensibility, originating a pathology with a own clinical entity, the Short Hamstring Syndrome (SHS), in addition to other problems on adjacent structures. All this present a great socioeconomic impact in the investigator's society. Various techniques have been demostrated to prduce an increase in flexibility, among which are the fascial techniques.
Objective: to evaluate the immediate efficacy of the treatment of the lumbar fascia in the flexibility of the hamstring musculature.
Methods: 41 women between 18 and 39 years old, in two groups. The experimental group received a technique of fascial stretching in the lumbar area while the control group participated in an off magnetotherapy machine. The hamstring flexibility in both lower limbs was measured by the Straight Leg Raising Test (SLR) and the Passive Popliteal Angle Test (PKE).
Detailed description
The hamstring muscles has a great tendency to decrease its extensibility, originating a pathology with a own clinical entity, the Short Hamstring Syndrome (SHS), in addition to other problems on adjacent structures. This study aims to help improve treatment for the problem mentioned before, which can be included within a therapeutic framework to combat SHS. In recent years, investigations have been carried out that include different techniques for stretching the hamstring muscles, as well as the treatment of other structures belonging to the posterior superficial chain. Within this last section, myofascial stretching techniques have been shown to be effective both in the short and medium term. Different techniques for stretching the hamstring muscles have been carried out with the aim of increasing the flexibility of the lower back in general.
he objective is to evaluate the immediate efficacy of the treatment of the lumbar fascia in the flexibility of the hamstring musculature.
The participants are 41 women between 18 and 39 years old, in two groups. The experimental group received a technique of fascial stretching in the lumbar area while the control group participated in an off magnetotherapy machine. The hamstring flexibility in both lower limbs was measured by the Straight Leg Raising Test (SLR) and the Passive Popliteal Angle Test (PKE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascial treatment | Experimental | Other: Treatment of the lumbar fasciaeTreatment the lumbar fasciae |
| Placebo group | Placebo comparator | Other: Placebo interventionIntroduce in a machine off |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female between 18 and 39 years old.
- Signed informed consent
Key exclusion criteria (5 listed)
- Any alteration that prevents the normal communication between the patient and the therapist at the time of the study.
- Have an injury in the hamstring muscles.
- Have a chronic or acute lumbar pain in the moment of the realization.
- Neurological or orthopedic desease.
- Any important estructural alteration in the lower members that may be likely to alter the results under study.
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 |
|---|---|---|
| Treatment of the lumbar fasciaeTreat the lumbar facial with a manual technique | Other | Fascial treatment |
| Placebo interventionIntroduce in a machine off | Other | Placebo group |
Primary outcome
Change from Straight Leg Raising Test (SLR)
Time frame: Pre-intervention and immediately after the intervention
Test
Change from Passive Popliteal Angle Test (PKE)
Time frame: Pre-intervention and immediately after the intervention
Test
1 secondary outcome
IPAQ
Time frame: Pre-intervention
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 14 Apr 2020.
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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.
Juan Javier Bru Ruiz principal investigator
Universidad Católica San Antonio de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment of the lumbar fasciae in people with Hamstring Injury, run by Universidad Católica San Antonio de Murcia 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 2 inclusion and 5 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 14 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 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?
Change from Straight Leg Raising Test (SLR) (time frame: Pre-intervention and immediately after the intervention). The study lists 2 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 14 Apr 2020.