Hamstring ContracturesNCT03637439
Neuromodulation in Patients With Hamstring Shortening
A study testing Ultrasound-guided Percutaneous Neuromodulation and Ultrasound-guided Percutaneous Needle in people with Hamstring Contractures, run by Jose Antonio Garcia Vidal at 1 site in Spain.
Trial summary
The flexibility of the hamstrings is a very important component both for general health and when exercising. The lack of hamstring flexibility has been related to the increase in the likelihood of suffering a large number of musculoskeletal pathologies, due to the possibility of causing important muscle imbalances… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hamstring Contractures
- What is being tested?
- Ultrasound-guided Percutaneous Neuromodulation and Ultrasound-guided Percutaneous Needle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 11 Jul 2018to 11 Aug 2018
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years
- to practice some sports activity 2 or more times a week
- get less than 70º in PKE (Passive Knee Extension) with hip 90º
Who cannot join
- any previous surgery or acute trauma in the back or lower extremity.
- pain at the time of performing the assessment tests
- belonephobia
- anticoagulant consumption
- pregnancy
- hemorrhagic disorders
- immunosuppression
- inability to understand or carry out evaluations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Ultrasound-guided Percutaneous Neuromodulation on Flexibility and Hamstring Force
The flexibility of the hamstrings is a very important component both for general health and when exercising. The lack of hamstring flexibility has been related to the increase in the likelihood of suffering a large number of musculoskeletal pathologies, due to the possibility of causing important muscle imbalances, which include lumbar spine pathologies, such as disc hernias or spondyloarthrosis. In addition, the decrease in the flexibility of the hamstring musculature is also related to the increased likelihood of suffering muscle strains, patellar tendon tendinopathies, femoropatellar syndrome and decreased lumbopelvic rhythm.
Clinically, an invasive technique has appeared, known as Ultrasound-guided Percutaneous Neuromodulation (PNM). This minimally invasive intervention consists in the application of a percutaneous electrical stimulation (PES) through an acupuncture needle-like electrode that is placed in close proximity to the nerve or motor point of the muscle with ultrasound guidance. At the clinical level, the PES is always used with the therapeutic aim of relieving chronic pain and neuropathic pain. Similarly, in sports, PES is used with the aim of improving muscular activity. Therefore, according to the characteristics and the therapeutic benefits of this technique, further research is needed to discover multiple clinical indications.
The aim of this study was to examine the effects on flexibility and strength of an ultrasound-guided percutaneous neuromodulation intervention in patients with shortening of the hamstring muscles.
- Conditions
- Hamstring Contractures
- Being tested
- Ultrasound-guided Percutaneous Neuromodulation, Ultrasound-guided Percutaneous Needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Percutaneous NeuromodulationOther
It's a new intervention of sport physiotherapy. It´s an invasive technique. It is necessary an ultrasound
Ultrasound-guided Percutaneous NeedleOther
Same protocol without electricity
| Study group | Role | What they receive |
|---|---|---|
| PNM group | Experimental | Subjects were treated only once. Specifically, this consisted in the application of a square wave biphasic electrical current, with 10 Hz frequency, a 250µs pulse width, and the maximal tolerable intensity to cause an exacerbated muscle contraction for a total of 1.5 mins, according to the protocol (Valera \& Minaya). The subjects were lying prone in decubitus. The middle part of the sciatic nerve was located using an ultrasound machine (cross section), then an acupuncture needle (0.30 mm x 40 mm) was inserted in a short axis approach, perpendicular to the surface of the skin, to the perineurium of the sciatic nerve. Receives: Other: Ultrasound-guided Percutaneous Neuromodulation |
| Control group | Sham comparator | The subjects were lying prone in decubitus. The same puncture protocol was performed on the sciatic nerve for 1.5 minutes, but without the application of electricity. Receives: Other: Ultrasound-guided Percutaneous Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Passive Knee Extension 90º [PKE 90º] [Hamstring Flexibility test] 5 minutes after intervention
Passive Knee Extension with hip 90º. The examiner will measure the popliteal angle (between the femur and the tibia) with a goniometer.
Measured: Baseline and 5 minutes after intervention
Secondary outcomes (2)
Change from Sit and Reach Flexibility Test [Hamstring Flexibility test] 5 minutes after intervention
The sit and reach test is a common measure of flexibility of the lower back and hamstring muscles. Using a standard sit and reach box, the participant sat on the floor with shoes on, and fully extended one leg so that the sole of the foot was flat against the end of the box. She then extended her arms forward, placing one hand on top of the other. With palms down, she reached forward sling hands along the measuring scale as far as possible without bending the knee of the extended leg.
Measured: Baseline and 5 minutes after intervention
Change from Stand and Reach Flexibility Test [Hamstring Flexibility test] 5 minutes after intervention
The volunteer standing with his knees extended tries to touch the ground with his extended hands. The examiner will measure with a ruler the distance in centimeters between the floor and the tips of fingers.
Measured: Baseline and 5 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start11 Jul 2018
- Primary completion11 Aug 2018
- Study completion11 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hamstring ContracturesStudies 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, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jose Antonio Garcia Vidal
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Murcia
- Responsible party
- Sponsor-investigator, Jose Antonio Garcia Vidal, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637439
- Sponsor's protocol ID
- 1858/2018
- Status last verified
- Aug 2018
- First submitted
- 11 Aug 2018
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ultrasound-guided Percutaneous Neuromodulation on Flexibility and Hamstring Force
- ClinicalTrials.gov ID
- NCT03637439
- Acronym / sponsor ID
- 1858/2018
- Conditions
- Hamstring Contractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jose Antonio Garcia VidalUniversity, hospital or other
- Collaborators
- Universidad de Murcia
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 11 Aug 2018 (actual)
- Study completion
- 11 Aug 2018 (actual)
- First posted
- 20 Aug 2018 (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 flexibility of the hamstrings is a very important component both for general health and when exercising. The lack of hamstring flexibility has been related to the increase in the likelihood of suffering a large number of musculoskeletal pathologies, due to the possibility of causing important muscle imbalances, which include lumbar spine pathologies, such as disc hernias or spondyloarthrosis. In addition, the decrease in the flexibility of the hamstring musculature is also related to the increased likelihood of suffering muscle strains, patellar tendon tendinopathies, femoropatellar syndrome and decreased lumbopelvic rhythm.
Clinically, an invasive technique has appeared, known as Ultrasound-guided Percutaneous Neuromodulation (PNM). This minimally invasive intervention consists in the application of a percutaneous electrical stimulation (PES) through an acupuncture needle-like electrode that is placed in close proximity to the nerve or motor point of the muscle with ultrasound guidance. At the clinical level, the PES is always used with the therapeutic aim of relieving chronic pain and neuropathic pain. Similarly, in sports, PES is used with the aim of improving muscular activity. Therefore, according to the characteristics and the therapeutic benefits of this technique, further research is needed to discover multiple clinical indications.
The aim of this study was to examine the effects on flexibility and strength of an ultrasound-guided percutaneous neuromodulation intervention in patients with shortening of the hamstring muscles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNM group | Experimental | Other: Ultrasound-guided Percutaneous NeuromodulationSubjects were treated only once. Specifically, this consisted in the application of a square wave biphasic electrical current, with 10 Hz frequency, a 250µs pulse width, and the maximal tolerable intensity to cause an exacerbated muscle contraction for a total of 1.5 mins, according to the protocol (Valera \& Minaya). The subjects were lying prone in decubitus. The middle part of the sciatic nerve was located using an ultrasound machine (cross section), then an acupuncture needle (0.30 mm x 40 mm) was inserted in a short axis approach, perpendicular to the surface of the skin, to the perineurium of the sciatic nerve. |
| Control group | Sham comparator | Other: Ultrasound-guided Percutaneous NeedleThe subjects were lying prone in decubitus. The same puncture protocol was performed on the sciatic nerve for 1.5 minutes, but without the application of electricity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- over 18 years
- to practice some sports activity 2 or more times a week
- get less than 70º in PKE (Passive Knee Extension) with hip 90º
Key exclusion criteria (8 listed)
- any previous surgery or acute trauma in the back or lower extremity.
- pain at the time of performing the assessment tests
- belonephobia
- anticoagulant consumption
- pregnancy
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 |
|---|---|---|
| Ultrasound-guided Percutaneous NeuromodulationIt's a new intervention of sport physiotherapy. It´s an invasive technique. It is necessary an ultrasound | Other | PNM group |
| Ultrasound-guided Percutaneous NeedleSame protocol without electricity | Other | Control group |
Primary outcome
Change from Passive Knee Extension 90º [PKE 90º] [Hamstring Flexibility test] 5 minutes after intervention
Time frame: Baseline and 5 minutes after intervention
Passive Knee Extension with hip 90º. The examiner will measure the popliteal angle (between the femur and the tibia) with a goniometer.
2 secondary outcomes
Change from Sit and Reach Flexibility Test [Hamstring Flexibility test] 5 minutes after intervention
Time frame: Baseline and 5 minutes after intervention
Change from Stand and Reach Flexibility Test [Hamstring Flexibility test] 5 minutes after intervention
Time frame: Baseline and 5 minutes after 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 20 Aug 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided Percutaneous Neuromodulation and Ultrasound-guided Percutaneous Needle in people with Hamstring Contractures, run by Jose Antonio Garcia Vidal 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 20 Aug 2018. 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 Passive Knee Extension 90º [PKE 90º] [Hamstring Flexibility test] 5 minutes after intervention (time frame: Baseline and 5 minutes after intervention). 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 20 Aug 2018.