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

Chronic Low-back Pain Clinical Trial

Official title:

Comparing Effectiveness Two Intratissue Percutaneous Electrolysis (EPI) Interventions for Chronic Low Back Pain: Lumbar Nerve Root Stimulation vs Trigger Points Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04290221
• Other study ID #: UALBIO2019/037
• Status: Completed
• Phase: N/A
• Start date: November 30, 2021
• Est. completion date: June 4, 2023

Study information

• Verified date: September 2023
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 4, 2023
• Est. primary completion date: March 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 67 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• Ultrasound-guided percutaneous electrolysis in the lumbar nerve root
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 (one times per week / 3 weeks). The intervention will be guided by ultrasound equipment medically certified (Directive 93/42 / EEC) device (EPI Advanced Medicine, Barcelona, Spain).
• Electrical Dry Needling in trigger points
It consists in apply the ultrasound-guided percutaneous electrolysis 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).

Locations

Country	Name	City	State
Spain	Universidad de Almeria	Almería	Almeria

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

References & Publications (12)

Abat F, Gelber PE, Polidori F, Monllau JC, Sanchez-Ibanez JM. Clinical results after ultrasound-guided intratissue percutaneous electrolysis (EPI(R)) and eccentric exercise in the treatment of patellar tendinopathy. Knee Surg Sports Traumatol Arthrosc. 2015 Apr;23(4):1046-52. doi: 10.1007/s00167-014-2855-2. Epub 2014 Jan 30. — View Citation

Arias-Buria JL, Truyols-Dominguez S, Valero-Alcaide R, Salom-Moreno J, Atin-Arratibel MA, Fernandez-de-Las-Penas C. Ultrasound-Guided Percutaneous Electrolysis and Eccentric Exercises for Subacromial Pain Syndrome: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2015;2015:315219. doi: 10.1155/2015/315219. Epub 2015 Nov 15. — View Citation

de Miguel Valtierra L, Salom Moreno J, Fernandez-de-Las-Penas C, Cleland JA, Arias-Buria JL. Ultrasound-Guided Application of Percutaneous Electrolysis as an Adjunct to Exercise and Manual Therapy for Subacromial Pain Syndrome: A Randomized Clinical Trial. J Pain. 2018 Oct;19(10):1201-1210. doi: 10.1016/j.jpain.2018.04.017. Epub 2018 May 16. — View Citation

Freeman MD, Woodham MA, Woodham AW. The role of the lumbar multifidus in chronic low back pain: a review. PM R. 2010 Feb;2(2):142-6; quiz 1 p following 167. doi: 10.1016/j.pmrj.2009.11.006. — View Citation

Goubert D, Oosterwijck JV, Meeus M, Danneels L. Structural Changes of Lumbar Muscles in Non-specific Low Back Pain: A Systematic Review. Pain Physician. 2016 Sep-Oct;19(7):E985-E1000. — View Citation

Iborra-Marcos A, Ramos-Alvarez JJ, Rodriguez-Fabian G, Del Castillo-Gonzalez F, Lopez-Roman A, Polo-Portes C, Villanueva-Martinez M. Intratissue Percutaneous Electrolysis vs Corticosteroid Infiltration for the Treatment of Plantar Fasciosis. Foot Ankle Int. 2018 Jun;39(6):704-711. doi: 10.1177/1071100718754421. Epub 2018 Feb 13. — View Citation

Jensen TS, Karppinen J, Sorensen JS, Niinimaki J, Leboeuf-Yde C. Vertebral endplate signal changes (Modic change): a systematic literature review of prevalence and association with non-specific low back pain. Eur Spine J. 2008 Nov;17(11):1407-22. doi: 10.1007/s00586-008-0770-2. Epub 2008 Sep 12. — View Citation

Shahidi B, Fisch KM, Gibbons MC, Ward SR. Increased Fibrogenic Gene Expression in Multifidus Muscles of Patients With Chronic Versus Acute Lumbar Spine Pathology. Spine (Phila Pa 1976). 2020 Feb 15;45(4):E189-E195. doi: 10.1097/BRS.0000000000003243. — View Citation

Shahidi B, Hubbard JC, Gibbons MC, Ruoss S, Zlomislic V, Allen RT, Garfin SR, Ward SR. Lumbar multifidus muscle degenerates in individuals with chronic degenerative lumbar spine pathology. J Orthop Res. 2017 Dec;35(12):2700-2706. doi: 10.1002/jor.23597. Epub 2017 May 23. — View Citation

Shahidi B, Parra CL, Berry DB, Hubbard JC, Gombatto S, Zlomislic V, Allen RT, Hughes-Austin J, Garfin S, Ward SR. Contribution of Lumbar Spine Pathology and Age to Paraspinal Muscle Size and Fatty Infiltration. Spine (Phila Pa 1976). 2017 Apr 15;42(8):616-623. doi: 10.1097/BRS.0000000000001848. — View Citation

Tuzun EH, Gildir S, Angin E, Tecer BH, Dana KO, Malkoc M. Effectiveness of dry needling versus a classical physiotherapy program in patients with chronic low-back pain: a single-blind, randomized, controlled trial. J Phys Ther Sci. 2017 Sep;29(9):1502-1509. doi: 10.1589/jpts.29.1502. Epub 2017 Sep 15. — View Citation

Valera-Garrido F, Minaya-Munoz F, Medina-Mirapeix F. Ultrasound-guided percutaneous needle electrolysis in chronic lateral epicondylitis: short-term and long-term results. Acupunct Med. 2014 Dec;32(6):446-54. doi: 10.1136/acupmed-2014-010619. Epub 2014 Aug 13. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Algometry	An instrument for measuring the degree of sensitivity to pain. We will carry out a location of the myofascial trigger points following the illustrations of location of the myofascial trigger points that indicate Travell and Simons of both the left and right hemibody.; Once located they will be classified as active or latent. Measured in kg / cm 2 with an analog pressure algometer model Wagner FDK20. To carry out this diagnosis using the analog pressure algometer, a force of 1Kg / sec will be applied until the subject indicates with a "YA" presence of pain, at that time we will stop the pressure made with the analog pressure algometer and record the result. The measurement will be executed 3 times with a 30 sec rest between each measurement and an average of the 3 results obtained will be obtained.; Myofascial trigger points that do not meet the above criteria will be considered latent and which will not be subject to any treatment.	At baseline, at 1 week after the last intervention, and 1-month follow-up period.
Primary	Change from baseline in Roland Morris Disability Questionnaire (RMDQ).	This is a self-reported questionnaire consisting in 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities.	At baseline, at 1 week after the last intervention, and 1-month follow-up period.
Secondary	Change from baseline in disability. Oswestry Low Back Pain Disability Idex.	It has 10 items associated to activities of daily living, each item has a punctuation from 0 to 5 points.	At baseline, at 1 week after the last intervention, and 1-month follow-up period.
Secondary	Change from baseline in pain intensity. Visual analogue scale.	A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain	At baseline, at 1 week after the last intervention, and 1-month follow-up period.
Secondary	Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.	Is a 17-item questionnaire that measures the fear of movement and (re)injury.	At baseline, at 1 week after the last intervention, and 1-month follow-up period.
Secondary	Change from baseline on Quality of Life. SF-36 Health questionnaire.	SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.	At baseline, at 1 week after the last intervention, and 1-month follow-up period.
Secondary	Change from Mcquade Test.	It measures the isometric endurance of trunk flexion muscles.	At baseline, at 1 week after the last intervention, and 1-month follow-up period.
Secondary	Change from baseline in range of motion and lumbar segmental mobility	This variable is quantified using the SpinalMouse ® device (Phisiotech, Spain). It is an electronic computer-aided measuring device that measures sagittal spinal amplitude of movement (ROM) and intersegmental angles in a non-invasive way.	At baseline, at 1 week after the last intervention, and 1-month follow-up period.
Secondary	Change from baseline in Fingers-floor distance (cm)	The patient flexes the trunk forward from the standing position, and the distance from the fingers to the ground is measured.	At baseline, at 1 week after the last intervention, and 1-month follow-up period.