Muscle Tone AbnormalitiesNCT03084341
Effectiveness of Two Stretching Techniques on Healthy Volunteers With Shortened Hamstrings
A study testing Neuromuscular Electrical Elongation and Proprioceptive Neuromuscular Facilitation in people with Muscle Tone Abnormalities, run by Universidad San Jorge at 1 site in Spain.
Trial summary
The main objective of this study is to compare the effect and the duration of the Neuromuscular Electrical Elongation (NMEE ) technique versus the PNF technique and versus a control group, on the extensibility of the hamstrings muscles. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Tone Abnormalities
- What is being tested?
- Neuromuscular Electrical Elongation and Proprioceptive Neuromuscular Facilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- 13 Mar 2017to 30 Jun 2017
- 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 Volunteers
- Older than 18 years
- Bilateral shortened hamstrings muscles with a knee extension under 60º (TEAR, Neto et al., 2015) and a ROM under 80º in the hip (straight leg raise test angle, Espejo-Antúnez et al., 2015)
Who cannot join
- Participation in a muscular stretching program during the study
- Previous history of surgical intervention in the hip, tight or knee
- Muscle-skeletal pain or injury in the low back or inferior limbs
- Abdominal o spine surgery within three month before the study beginning.
- Exit Criteria:
- Patient´s petition
- Change in the regular physical activity level during the study period
- Appearance of an injury that would contraindicate the use of stretching techniques
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study is to compare the effect and the duration of the Neuromuscular Electrical Elongation (NMEE ) technique versus the PNF technique and versus a control group, on the extensibility of the hamstrings muscles.
Hypothesis:
NMEE of shortened hamstrings muscles in healthy subjects, compared with PNF and control group produces a significant increase in hamstrings extensibility.
Read the detailed description
It is a double-blinded randomized clinical trial where subjects are healthy volunteers from the city of Zaragoza older than 18 years. All subjects will be injury free at the time of the study and must not have a history of knee or hip surgery. They must be physically active, but without engaging in competition-level sports, and must have flexibility deficits, as measured in the AKE test position and SLK test position (<60º AKE; < 80º SLK).
There will be an NMEE Group (Neuromuscular Electrical Elongation), an PNF Group (Proprioceptive Neuromuscular Facilitation) and a Control Group (No Invervention).
Intervention:
NMEE technique will be performed by stretching the muscle till resistance and applying a bipolar interferential current to produce an involuntary contraction of the muscle which will be maintained 3 seconds. After that, the subject will contract the antagonist muscle (quadriceps) actively until he feels resistance again . Then, intensity of the electrical current is increased again. This cycle will be repeated 4 times.
PNF technique will be performed by stretching the muscle till resistance is felt. Then the patient will have to make an isometric contraction of the muscle (against resistance) during 3 seconds. After that, the subject will contract the antagonist muscle (quadriceps) actively until he feels resistance again. This contract-stretch cycle will be repeated 4 times.
Control group: This group will not receive a training program.
In case of shortening, the assigned intervention will be performed until the values considered normal with a maximum of 8 stretching sessions (2 per week). Otherwise, if there is no shortening, the intervention will end at that moment.
Assessment:
To assess the effectiveness of these techniques several tests will be performed on the subjects.
For hamstrings extensibility:
- Active-Knee-Extension Test (AKE) results will bring information of the knee extension range of motion.
- Straight-Leg-Raise Test (SLR) results will bring information of the hip flexion range of motion.
For quadriceps extensibility:
- Goniometric measure of knee flexion.
- Distance from heel to gluteus using a tape measure.
Viscoelasticity properties of hamstrings and quadriceps muscles:
- Myotonometric measurement using a myotonometer to obtain frequency, decrement (elasticity) and stiffness.
For neural assessment:
- The Slump Test is a neural tension test used to detect altered neurodynamics or neural tissue sensitivity.
- Conditions
- Muscle Tone Abnormalities
- Being tested
- Neuromuscular Electrical Elongation, Proprioceptive Neuromuscular Facilitation
- Keywords
- Elasticity, Electric Stimulation, Muscle Stretching Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical ElongationProcedure or surgery
Electrotherapy equipment will be used, choosing an interferential current through bipolar application,with a frequency of 4 kHz and a frequency modulation amplitude of 100 Hz.
Proprioceptive Neuromuscular FacilitationProcedure or surgery
Hold-relax technique that involves lengthening the muscle to the point of limitation, at which point the individual performs an isometric contraction for up to 10 s, followed by a passive movement of the limb into the new end-range.
| Study group | Role | What they receive |
|---|---|---|
| NMEE Group | Active comparator | Neuromuscular Electrical Elongation Receives: Procedure: Neuromuscular Electrical Elongation |
| PNF Group | Active comparator | Proprioceptive Neuromuscular Facilitation stretching Receives: Procedure: Proprioceptive Neuromuscular Facilitation |
| Control Group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Active-knee-extension test (AKE)
The AKE is performed using an experimental apparatus designed specifically for this investigation. It consists of a rectangular wooden frame that is attached to an examination table. The tested limb is flexed until the thigh touched the wooden frame, being at 90° with the table. The contralateral limb is fully extended and stabilized in neutral rotation by a second examiner. With the foot in neutral position and the knee flexed at 90°, a standard universal goniometer is placed over the lateral femoral condyle, with 1 arm aligned along the thigh in direction to the greater trochanter and the other arm aligned over the leg in the direction of the lateral malleolus.
From this position, and without any prior warm-up subjects will be instructed to extend the knee until they felt a strong resistance, holding this final position for 2 to 3 seconds to allow the goniometric reading.
Measured: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last intervention)
Change in Straight-leg-raise test (SLR)
For the SLR test, a normal examination table is used. Participants lay supine and must be relaxed throughout the test. The tested limb is flexed by the examiner, with the knee fully extended and the foot in a relaxed position. The contralateral limb is secured by a second examiner, fully extended and in neutral rotation.
The movement stops when the tester feels a strong resistance or when pelvic rotation is observed. The goniometer is placed over the greater trochanter, with 1 arm aligned with the lateral femoral condyle and the other aligned parallel to the table, in the direction of the midaxillary line.
Measured: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last intervention)
Secondary outcomes (5)
Change in Quadriceps Muscle Extensibility
The assessor slowly bends the subject's knee so that the heel approximated the buttock. Attention is paid ensuring that there is no lumbar spine or pelvic movement or cramping of the hamstrings and that the thighs remained parallel. The subject is asked to report as soon as a first sensation of stretch is experienced in the quadriceps muscle. The closest distance from the relaxed buttock to the heel with the ankle passively plantar flexed, is measured with a goniometer. By holding the ankle and the weight of the lower leg, the assessor ensures that the quadriceps is itself not stretched in any way during this procedure as this could be interpreted as a treatment, rather than assessment.
Measured: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last intervention)
Change in Frequency
Frequency of muscle oscillations (Hz) is an indicator of the tone.This outcome measure is obtained by a device named MyotonPro. It is a non-invasive commercial device made to calculate myotonometrics properties of the muscle.
Measured: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last intervention)
Change in Stiffness
The muscle stiffness reflects muscle resistance to the force that changes its shape (Nm). This outcome measure is obtained by a device named MyotonPro. It is a non-invasive commercial device made to calculate myotonometrics properties of the muscle.
Measured: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last intervention)
Change in Decrement (elasticity)
Logarithmic decrement of the dampening of muscle oscillations is an indicator of the elasticity. This outcome measure is obtained by a device named MyotonPro. It is a non-invasive commercial device made to calculate myotonometrics properties of the muscle.
Measured: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last intervention)
Change in Neural Measures
To begin the test, patient must be seated with hands behind back to achieve a neutral spine. The first step is to have the patient slump forward at the thoracic and lumbar spine. If this position does not cause pain, patient must flex the neck by placing the chin on the chest and then extending one knee as much as possible.
If extending the knee causes pain, patient must extend the neck into neutral. If the patient is still unable to extend the knee due to pain, the test is considered positive.
If extending the knee does not cause pain, patient must do actively dorsiflexion of the ankle. If dorsiflexion causes pain, have the patient slightly flex the knee while still dorsiflexing. If the pain is reproduced, the test is considered positive.
Measured: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start13 Mar 2017
- Primary completion1 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Tone AbnormalitiesStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Ortiz-Lucas, Principal investigator, Universidad San Jorge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084341
- Sponsor's protocol ID
- 04/2016
- Status last verified
- Jan 2021
- First submitted
- 7 Nov 2016
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two Stretching Techniques on Healthy Volunteers With Shortened Hamstrings
- ClinicalTrials.gov ID
- NCT03084341
- Acronym / sponsor ID
- 04/2016
- Conditions
- Muscle Tone Abnormalities
- Keywords
- Elasticity, Electric Stimulation, Muscle Stretching Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 20 Mar 2017 (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 main objective of this study is to compare the effect and the duration of the Neuromuscular Electrical Elongation (NMEE ) technique versus the PNF technique and versus a control group, on the extensibility of the hamstrings muscles.
Hypothesis:
NMEE of shortened hamstrings muscles in healthy subjects, compared with PNF and control group produces a significant increase in hamstrings extensibility.
Detailed description
It is a double-blinded randomized clinical trial where subjects are healthy volunteers from the city of Zaragoza older than 18 years. All subjects will be injury free at the time of the study and must not have a history of knee or hip surgery. They must be physically active, but without engaging in competition-level sports, and must have flexibility deficits, as measured in the AKE test position and SLK test position (<60º AKE; < 80º SLK).
There will be an NMEE Group (Neuromuscular Electrical Elongation), an PNF Group (Proprioceptive Neuromuscular Facilitation) and a Control Group (No Invervention).
Intervention:
NMEE technique will be performed by stretching the muscle till resistance and applying a bipolar interferential current to produce an involuntary contraction of the muscle which will be maintained 3 seconds. After that, the subject will contract the antagonist muscle (quadriceps) actively until he feels resistance again . Then, intensity of the electrical current is increased again. This cycle will be repeated 4 times.
PNF technique will be performed by stretching the muscle till resistance is felt. Then the patient will have to make an isometric contraction of the muscle (against resistance) during 3 seconds. After that, the subject will contract the antagonist muscle (quadriceps) actively until he feels resistance again. This contract-stretch cycle will be repeated 4 times.
Control group: This group will not receive a training program.
In case of shortening, the assigned intervention will be performed until the values considered normal with a maximum of 8 stretching sessions (2 per week). Otherwise, if there is no shortening, the intervention will end at that moment.
Assessment:
To assess the effectiveness of these techniques several tests will be performed on the subjects.
For hamstrings extensibility:
- Active-Knee-Extension Test (AKE) results will bring information of the knee extension range of motion.
- Straight-Leg-Raise Test (SLR) results will bring information of the hip flexion range of motion.
For quadriceps extensibility:
- Goniometric measure of knee flexion.
- Distance from heel to gluteus using a tape measure.
Viscoelasticity properties of hamstrings and quadriceps muscles:
- Myotonometric measurement using a myotonometer to obtain frequency, decrement (elasticity) and stiffness.
For neural assessment:
- The Slump Test is a neural tension test used to detect altered neurodynamics or neural tissue sensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NMEE Group | Active comparator | Procedure: Neuromuscular Electrical ElongationNeuromuscular Electrical Elongation |
| PNF Group | Active comparator | Procedure: Proprioceptive Neuromuscular FacilitationProprioceptive Neuromuscular Facilitation stretching |
| Control Group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy Volunteers
- Older than 18 years
- Bilateral shortened hamstrings muscles with a knee extension under 60º (TEAR, Neto et al., 2015) and a ROM under 80º in the hip (straight leg raise test angle, Espejo-Antúnez et al., 2015)
Key exclusion criteria (8 listed)
- Participation in a muscular stretching program during the study
- Previous history of surgical intervention in the hip, tight or knee
- Muscle-skeletal pain or injury in the low back or inferior limbs
- Abdominal o spine surgery within three month before the study beginning.
- Patient´s petition
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 |
|---|---|---|
| Neuromuscular Electrical ElongationElectrotherapy equipment will be used, choosing an interferential current through bipolar application,with a frequency of 4 kHz and a frequency modulation amplitude of 100 Hz. | Procedure or surgery | NMEE Group |
| Proprioceptive Neuromuscular FacilitationHold-relax technique that involves lengthening the muscle to the point of limitation, at which point the individual performs an isometric contraction for up to 10 s, followed by a passive movement of the limb into the new end-range. | Procedure or surgery | PNF Group |
Primary outcome
Change in Active-knee-extension test (AKE)
Time frame: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last intervention)
The AKE is performed using an experimental apparatus designed specifically for this investigation. It consists of a rectangular wooden frame that is attached to an examination table. The tested limb is flexed until the thigh touched the wooden frame, being at 90° with the table. The contralateral limb is fully extended and stabilized in neutral rotation by a second examiner. With the foot in neutral position and the knee flexed at 90°, a standard universal goniometer is placed over the lateral femoral condyle, with 1 arm aligned along the thigh in direction to the greater trochanter and the other arm aligned over the leg in the direction of the lateral malleolus. From this position, and without any prior warm-up subjects will be instructed to extend the knee until they felt a strong resistance, holding this final position for 2 to 3 seconds to allow the goniometric reading.
Change in Straight-leg-raise test (SLR)
Time frame: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last intervention)
For the SLR test, a normal examination table is used. Participants lay supine and must be relaxed throughout the test. The tested limb is flexed by the examiner, with the knee fully extended and the foot in a relaxed position. The contralateral limb is secured by a second examiner, fully extended and in neutral rotation. The movement stops when the tester feels a strong resistance or when pelvic rotation is observed. The goniometer is placed over the greater trochanter, with 1 arm aligned with the lateral femoral condyle and the other aligned parallel to the table, in the direction of the midaxillary line.
5 secondary outcomes
Change in Quadriceps Muscle Extensibility
Time frame: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last intervention)
Change in Frequency
Time frame: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last intervention)
Change in Stiffness
Time frame: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last intervention)
Change in Decrement (elasticity)
Time frame: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last intervention)
Change in Neural Measures
Time frame: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last 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 12 Jan 2021.
- 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.
Maria Ortiz-Lucas principal investigator
Universidad San Jorge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Elongation and Proprioceptive Neuromuscular Facilitation in people with Muscle Tone Abnormalities, run by Universidad San Jorge 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 8 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 12 Jan 2021. 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?
Change in Active-knee-extension test (AKE) (time frame: Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last 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 12 Jan 2021.