Neuromodulation in Patients With Hamstring Shortening

NCT ID: NCT03637439

Last Updated: 2018-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-11

Study Completion Date

2018-08-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hamstring Contractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PNM group

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.

Group Type EXPERIMENTAL

Ultrasound-guided Percutaneous Neuromodulation

Intervention Type OTHER

It's a new intervention of sport physiotherapy. It´s an invasive technique. It is necessary an ultrasound

Control group

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.

Group Type SHAM_COMPARATOR

Ultrasound-guided Percutaneous Needle

Intervention Type OTHER

Same protocol without electricity

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasound-guided Percutaneous Neuromodulation

It's a new intervention of sport physiotherapy. It´s an invasive technique. It is necessary an ultrasound

Intervention Type OTHER

Ultrasound-guided Percutaneous Needle

Same protocol without electricity

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad de Murcia

OTHER

Sponsor Role collaborator

Jose Antonio Garcia Vidal

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jose Antonio Garcia Vidal

Physiotherapist, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Physical Therapy Department. University of Murcia

Murcia, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1858/2018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.