Neuromodulation in Patients With Hamstring Shortening

NCT03637439 | Completed DMC

• 1 other identifier: 1858/2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hamstring Contractures

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 5 minutes after intervention

Secondary Outcomes (2)

• Change from Sit and Reach Flexibility Test [Hamstring Flexibility test] 5 minutes after intervention

  Baseline and 5 minutes after intervention

• Change from Stand and Reach Flexibility Test [Hamstring Flexibility test] 5 minutes after intervention

  Baseline and 5 minutes after intervention

Study Arms (2)

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.

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.

Other: Ultrasound-guided Percutaneous Needle

Interventions

Ultrasound-guided Percutaneous Neuromodulation OTHER

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

PNM group

Ultrasound-guided Percutaneous Needle OTHER

Same protocol without electricity

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jose Antonio Garcia Vidal: lead
• Universidad de Murcia: collaborator

Study Sites (1)

Physical Therapy Department. University of Murcia

Murcia, 30100, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist, PhD

Study Record Dates

• First Submitted: August 11, 2018
• First Posted: August 20, 2018
• Study Start: July 11, 2018
• Primary Completion: August 11, 2018
• Study Completion: August 11, 2018
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

ES (1)