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Neuromodulation in Patients With Hamstring Shortening

Primary Purpose

Hamstring Contractures

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ultrasound-guided Percutaneous Neuromodulation
Ultrasound-guided Percutaneous Needle
Sponsored by
Jose Antonio Garcia Vidal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hamstring Contractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Physical Therapy Department. University of Murcia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

PNM group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 11, 2018
Last Updated
August 16, 2018
Sponsor
Jose Antonio Garcia Vidal
Collaborators
Universidad de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT03637439
Brief Title
Neuromodulation in Patients With Hamstring Shortening
Official Title
Effects of Ultrasound-guided Percutaneous Neuromodulation on Flexibility and Hamstring Force
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 11, 2018 (Actual)
Primary Completion Date
August 11, 2018 (Actual)
Study Completion Date
August 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jose Antonio Garcia Vidal
Collaborators
Universidad de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hamstring Contractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PNM group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Ultrasound-guided Percutaneous Neuromodulation
Intervention Description
It's a new intervention of sport physiotherapy. It´s an invasive technique. It is necessary an ultrasound
Intervention Type
Other
Intervention Name(s)
Ultrasound-guided Percutaneous Needle
Intervention Description
Same protocol without electricity
Primary Outcome Measure Information:
Title
Change from Passive Knee Extension 90º [PKE 90º] [Hamstring Flexibility test] 5 minutes after intervention
Description
Passive Knee Extension with hip 90º. The examiner will measure the popliteal angle (between the femur and the tibia) with a goniometer.
Time Frame
Baseline and 5 minutes after intervention
Secondary Outcome Measure Information:
Title
Change from Sit and Reach Flexibility Test [Hamstring Flexibility test] 5 minutes after intervention
Description
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.
Time Frame
Baseline and 5 minutes after intervention
Title
Change from Stand and Reach Flexibility Test [Hamstring Flexibility test] 5 minutes after intervention
Description
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.
Time Frame
Baseline and 5 minutes after intervention

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Physical Therapy Department. University of Murcia
City
Murcia
ZIP/Postal Code
30100
Country
Spain

12. IPD Sharing Statement

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Neuromodulation in Patients With Hamstring Shortening

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