Muscle StretchingNCT04763798
Efficacy of Hamstring Stretching According to the Neural or Muscle Tissue Involvement
A study testing Straight-leg-raise (SLR), Passive Knee extension test (PKE) and Maximum hip flexion (MHF) in people with Muscle Stretching, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
Background: Muscle stretching is a technique widely used in the clinical practice of physiotherapy and in the field of sports. In the bibliography we find a multitude of stretches and procedures described, some of them being similar to neurodynamic tests, which could direct their effect to a neural and not a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Stretching
- What is being tested?
- Straight-leg-raise (SLR), Passive Knee extension test (PKE) and Maximum hip flexion (MHF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 11 Dec 2020to 20 Feb 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects over 18 years old who signed the informed consent.
Who cannot join
- The exclusion criteria were as follows: 1) injury in the thigh 6 months previously, 2) diagnosis of any orthopaedic problem or surgery in the lower limbs, 3) back pain or previous surgery in the spine or 4) systemic or neurological disorders.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
About this study
Background: Muscle stretching is a technique widely used in the clinical practice of physiotherapy and in the field of sports. In the bibliography we find a multitude of stretches and procedures described, some of them being similar to neurodynamic tests, which could direct their effect to a neural and not a musculoskeletal structure. The structural differentiation manoeuvre has been shown to be able to discriminate the increase in tension on the nerve.
Objective: To evaluate the short-term efficacy on ischiosural muscle elongation of three modalities of ischiosural stretching according to neural or muscular involvement, in subjects without previous pathology.
Design: Cross sectional study. Methods: A randomised, blinded, assessor-blinded clinical trial was performed. According to the sample size calculation, a total of 35 subjects will be recruited from the International University of Catalonia. Each subject will undergo three hamstring stretching techniques on their dominant leg, Straight-leg-raise (SLR), Passive knee extension (PKE) and Maximun hip flexion (MHF) with an interval of one week on the dominant leg. Muscle elongation in each stretching modality will be assessed with the modified black saver sit and reach test and whether the technique generates a neural or musculoskeletal response when performing the structural differentiation manoeuvre.
Read the detailed description
Background: Muscle stretching is a technique widely used in the clinical practice of physiotherapy and in the field of sports. In the bibliography we find a multitude of stretches and procedures described, some of them being similar to neurodynamic tests, which could direct their effect to a neural and not a musculoskeletal structure. The structural differentiation manoeuvre has been shown to be able to discriminate the increase in tension on the nerve.
Objective: To evaluate the short-term efficacy on ischiosural muscle elongation of three modalities of ischiosural stretching according to neural or muscular involvement, in subjects without previous pathology.
Design: Cross sectional study.
- Conditions
- Muscle Stretching
- Being tested
- Straight-leg-raise (SLR), Passive Knee extension test (PKE), Maximum hip flexion (MHF)
- Keywords
- Hamstring, Passive Knee extension test, Straight-leg-raise, maximun hip flexion, musculoskeletal response, nerve response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Straight-leg-raise (SLR)Other
The stretched lower limb was on a mobile support and the contralateral limb was stabilized with a belt on the bench. For the SLR, the knee was kept in full extension and then, hip flexion was performed until a marked resistance. All stretching modalities were applied until a marked resistance was felt by the physical therapist (end-feel) or until the point of maximal tolerance referred by subjects.The stretch lasted 30 seconds followed by 15 seconds rest period and the procedure was repeated 5 times. Each stretching was applied for 5 minutes
Passive Knee extension test (PKE)Other
The stretched lower limb was on a mobile support and the contralateral limb was stabilized with a belt on the bench. For the PKE, the hip was kept in 90º flexion and then, knee extension was performed. All stretching modalities were applied until a marked resistance was felt by the physical therapist (end-feel) or until the point of maximal tolerance referred by subjects.
The stretches lasted 30 seconds followed by 15 seconds rest period and the procedure was repeated 5 times. Each stretching was applied for 5 minutes
Maximum hip flexion (MHF)Other
The stretched lower limb was on a mobile support and the contralateral limb was stabilized with a belt on the bench. For MHF, a maximal hip flexion was performed and then, knee extension was applied. All stretching modalities were applied until a marked resistance was felt by the physical therapist (end-feel) or until the point of maximal tolerance referred by subjects.
The stretches lasted 30 seconds followed by 15 seconds rest period and the procedure was repeated 5 times. Each stretching was applied for 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| Dominant | Experimental | All subjects will receive the three stretching techniques on dominant leg. Interventions will be performed in three different days and only one of the three stretching exercises will be performed in each session. The rest period between sessions will be one week. Stretching exercises will be perform in a random order. A random-number generator will be used for randomization Receives: Other: Straight-leg-raise (SLR); Other: Passive Knee extension test (PKE); Other: Maximum hip flexion (MHF) |
| Non dominant | Active comparator | All subjects will receive the three stretching techniques on non dominant leg. Interventions will be performed in three different days and only one of the three stretching exercises will be performed in each session. The rest period between sessions will bé one week. Stretching exercises will be perform in a random order. A random-number generator will bé used for randomization Receives: Other: Straight-leg-raise (SLR); Other: Passive Knee extension test (PKE); Other: Maximum hip flexion (MHF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified back-saver sit-and-reach test
subjects will perform a single-leg sit-and-reach on a bench. The untested leg will be placed on the floor with knee at approximately 90º. A measuring tape will be placed on the bench. Subjects aligned the sole of the foot of the tested leg with the 50-cm mark on the measuring tape. Thereafter, subjects will be asked to reach forward as far as possible while maintaining the knees, arms, and fingers fully extended, and keep in the two hands on tip of each other and palms down
Measured: Through study completion, an average of 3 weeks.
Distal sensation
Passive ankle dorsiflexion was performed as distal sensation manoeuvre at the final position of all stretching modalities. Subjects were asked to indicate if the sensation during the stretching was modified during the ankle dorsiflexion (neural response) or was the same (musculoskeletal response)
Measured: Through study completion, an average of 3 weeks.
Force intensity applyed
The intensity of the force applied during each stretching modality was measured by a manual dynamometer (MicroFET2, Hoggan Scientific, Salt Lake City, Utah). The dynamometer was applied on the distal leg, proximal to the ankle joint. The physiotherapist performed the stretching until a marked resistance was felt and then, the force was registered.
Measured: Through study completion, an average of 3 weeks.
Secondary outcomes (1)
Perceived sensation
After the stretching application, all subjects were asked about their perceived sensation. They were asked about the intensity of the tension sensation during the technique. A numeric scale, ranging from 0 ("no tension") to 10 ("worst tension imaginable") was used to indicate the intensity of tension sensation during the stretching technique.
Measured: Through study completion, an average of 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start11 Dec 2020
- Primary completion11 Jan 2021
- Study completion20 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle StretchingStudies 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
- Model description
- Cross sectional study. Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos López de Celis, Universitat Internacional de Catalunya
- Investigators
- Carlos L López de Celis, Dr, Principal investigator, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763798
- Sponsor's protocol ID
- CBAS-2019-12
- Status last verified
- Feb 2021
- First submitted
- 12 Feb 2021
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hamstring Stretching According to the Neural or Muscle Tissue Involvement
- ClinicalTrials.gov ID
- NCT04763798
- Acronym / sponsor ID
- CBAS-2019-12
- Conditions
- Muscle Stretching
- Keywords
- Hamstring, Passive Knee extension test, Straight-leg-raise, maximun hip flexion, musculoskeletal response, nerve response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 20 Feb 2021 (actual)
- First posted
- 21 Feb 2021 (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.
Background: Muscle stretching is a technique widely used in the clinical practice of physiotherapy and in the field of sports. In the bibliography we find a multitude of stretches and procedures described, some of them being similar to neurodynamic tests, which could direct their effect to a neural and not a musculoskeletal structure. The structural differentiation manoeuvre has been shown to be able to discriminate the increase in tension on the nerve.
Objective: To evaluate the short-term efficacy on ischiosural muscle elongation of three modalities of ischiosural stretching according to neural or muscular involvement, in subjects without previous pathology.
Design: Cross sectional study. Methods: A randomised, blinded, assessor-blinded clinical trial was performed. According to the sample size calculation, a total of 35 subjects will be recruited from the International University of Catalonia. Each subject will undergo three hamstring stretching techniques on their dominant leg, Straight-leg-raise (SLR), Passive knee extension (PKE) and Maximun hip flexion (MHF) with an interval of one week on the dominant leg. Muscle elongation in each stretching modality will be assessed with the modified black saver sit and reach test and whether the technique generates a neural or musculoskeletal response when performing the structural differentiation manoeuvre.
Detailed description
Background: Muscle stretching is a technique widely used in the clinical practice of physiotherapy and in the field of sports. In the bibliography we find a multitude of stretches and procedures described, some of them being similar to neurodynamic tests, which could direct their effect to a neural and not a musculoskeletal structure. The structural differentiation manoeuvre has been shown to be able to discriminate the increase in tension on the nerve.
Objective: To evaluate the short-term efficacy on ischiosural muscle elongation of three modalities of ischiosural stretching according to neural or muscular involvement, in subjects without previous pathology.
Design: Cross sectional study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cross sectional study. Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Dominant | Experimental | Other: Straight-leg-raise (SLR), Other: Passive Knee extension test (PKE), Other: Maximum hip flexion (MHF)All subjects will receive the three stretching techniques on dominant leg. Interventions will be performed in three different days and only one of the three stretching exercises will be performed in each session. The rest period between sessions will be one week. Stretching exercises will be perform in a random order. A random-number generator will be used for randomization |
| Non dominant | Active comparator | Other: Straight-leg-raise (SLR), Other: Passive Knee extension test (PKE), Other: Maximum hip flexion (MHF)All subjects will receive the three stretching techniques on non dominant leg. Interventions will be performed in three different days and only one of the three stretching exercises will be performed in each session. The rest period between sessions will bé one week. Stretching exercises will be perform in a random order. A random-number generator will bé used for randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects over 18 years old who signed the informed consent.
Key exclusion criteria (1 listed)
- The exclusion criteria were as follows: 1) injury in the thigh 6 months previously, 2) diagnosis of any orthopaedic problem or surgery in the lower limbs, 3) back pain or previous surgery in the spine or 4) systemic or neurological disorders.
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-raise (SLR)The stretched lower limb was on a mobile support and the contralateral limb was stabilized with a belt on the bench. For the SLR, the knee was kept in full extension and then, hip flexion was performed until a marked resistance. All stretching modalities were applied until a marked resistance was felt by the physical therapist (end-feel) or until the point of maximal tolerance referred by subjects.The stretch lasted 30 seconds followed by 15 seconds rest period and the procedure was repeated 5 times. Each stretching was applied for 5 minutes | Other | Dominant, Non dominant |
| Passive Knee extension test (PKE)The stretched lower limb was on a mobile support and the contralateral limb was stabilized with a belt on the bench. For the PKE, the hip was kept in 90º flexion and then, knee extension was performed. All stretching modalities were applied until a marked resistance was felt by the physical therapist (end-feel) or until the point of maximal tolerance referred by subjects. The stretches lasted 30 seconds followed by 15 seconds rest period and the procedure was repeated 5 times. Each stretching was applied for 5 minutes | Other | Dominant, Non dominant |
| Maximum hip flexion (MHF)The stretched lower limb was on a mobile support and the contralateral limb was stabilized with a belt on the bench. For MHF, a maximal hip flexion was performed and then, knee extension was applied. All stretching modalities were applied until a marked resistance was felt by the physical therapist (end-feel) or until the point of maximal tolerance referred by subjects. The stretches lasted 30 seconds followed by 15 seconds rest period and the procedure was repeated 5 times. Each stretching was applied for 5 minutes | Other | Dominant, Non dominant |
Primary outcome
Modified back-saver sit-and-reach test
Time frame: Through study completion, an average of 3 weeks.
subjects will perform a single-leg sit-and-reach on a bench. The untested leg will be placed on the floor with knee at approximately 90º. A measuring tape will be placed on the bench. Subjects aligned the sole of the foot of the tested leg with the 50-cm mark on the measuring tape. Thereafter, subjects will be asked to reach forward as far as possible while maintaining the knees, arms, and fingers fully extended, and keep in the two hands on tip of each other and palms down
Distal sensation
Time frame: Through study completion, an average of 3 weeks.
Passive ankle dorsiflexion was performed as distal sensation manoeuvre at the final position of all stretching modalities. Subjects were asked to indicate if the sensation during the stretching was modified during the ankle dorsiflexion (neural response) or was the same (musculoskeletal response)
Force intensity applyed
Time frame: Through study completion, an average of 3 weeks.
The intensity of the force applied during each stretching modality was measured by a manual dynamometer (MicroFET2, Hoggan Scientific, Salt Lake City, Utah). The dynamometer was applied on the distal leg, proximal to the ankle joint. The physiotherapist performed the stretching until a marked resistance was felt and then, the force was registered.
1 secondary outcome
Perceived sensation
Time frame: Through study completion, an average of 3 weeks.
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 6 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
Carlos L López de Celis, Dr principal investigator
Universitat Internacional de Catalunya
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 (SLR), Passive Knee extension test (PKE) and Maximum hip flexion (MHF) in people with Muscle Stretching, run by Universitat Internacional de Catalunya 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 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 6 Sep 2022. 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. 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?
Modified back-saver sit-and-reach test (time frame: Through study completion, an average of 3 weeks.). The study lists 3 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 6 Sep 2022.