Effectiveness Analysis of Ultrasound-guided Intratissue Percutaneous Electrolysis (EPI) in Patient With Chronic Low Back Pain

Universidad de Almeria

Status: Completed

Conditions: Chronic Low-back Pain

Treatments: Other: Electrical Dry Needling in trigger points; Other: Ultrasound-guided percutaneous electrolysis in the lumbar nerve root

Study type: Interventional

Funder types: Other

Identifiers

NCT04290221

UALBIO2019/037

Details and patient eligibility

About

The main objective of this study is to analyze the effectiveness of the lumbar nerve root stimulation with ultrasound-guided percutaneous electrolysis versus the electrical dry needling of trigger points in patients with chronic low back pain.

Full description

Given that recently the effectiveness of intratissue percutaneous electrolysis (EPI) has become of interest in the treatment of chronic musculoskeletal pain, when conventional physiotherapy management is not successful, the EPI can promote the healing biological processes. Several studies have demonstrated that inflammation can play an important role in the progression of muscle degeneration, in addition to potentially contributing to painful symptoms in individuals with chronic low back pain.

This technique involves nonthermal, electrochemical ablation of the lesion via the use of a cathodic fluid. The inflammation provoked is very localized and healing is rapid. Although EPI has been widely employed lately, the literature contains few studies validating its use.

The good results reported in studies of tendinopathies have to the undertaking of the present work, which compares the long-term effectiveness of EPI and dry needling-both ultrasound-guided-for the treatment of chronic low back pain.

A double blind clinical trial will be developed in a sample of 80 subjects with chronic low back pain. Patients of experimental group will receive 1 weekly sessions of intratissue percutaneous electrolysis for 3 weeks, for a total of 3 sessions. The aim is to compare the effectiveness of applying percutaneous electrolysis in the lumbar nerve root versus applying electrical dry needling on trigger points of the gluteus medius, quadratus lumborum, and erector spinae muscles (6 sessions, once a week) on disability, pain, fear of movement, quality of life, resistance of the trunk flexors, lumbar mobility and muscular electrical activity.

Enrollment: 64 patients

Sex: All

Ages: 30 to 67 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Low back pain ≥ 3 months.
• Age between 30 and 67 years old.
• Score ≥ 4 points on the Roland Morris Disability Questionnaire.
• Not being receiving other physical therapy.

Exclusion criteria

• Presence of lumbar stenosis.
• Diagnosis of spondylolisthesis.
• Diagnosis of fibromyalgia.
• Treatment with corticosteroids or oral medication in recent weeks.
• History of spine surgery.
• Contraindication of analgesic electrical therapy.
• Have previously received a treatment of intratissue percutaneous electrolysis.
• Central or peripheral nervous system disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

64 participants in 2 patient groups

Percutaneous electrolysis in the lumbar nerv

Experimental group

Description:

This group will be treated with intratissue percutaneous electrolysis using a needle G32 with galvanic current as a cathodic flow electrode in the posterior nerve root of L3, L4 and L5, bilaterally (one times per week / 6 weeks). The intervention will be guided by ultrasound equipment medically certified (Directive 93/42 / EEC) device (EPI Advanced Medicine, Barcelona, Spain).

Treatment:

Other: Ultrasound-guided percutaneous electrolysis in the lumbar nerve root

Electrical dry needling in trigger points

Active Comparator group

Description:

It consists in apply the electrical dry needling on active and/or latent TPs in the gluteus medius, quadratus lumborum, and erector spinae muscles of the subjects L3 (one times per week / 6 weeks).

Treatment:

Other: Electrical Dry Needling in trigger points