Clinical trial NCT04290221: Effectiveness Analysis of Ultrasound-guided Intratissue Percutaneous Electrolysis (EPI) in Patient With Chronic Low Back Pain
Official title: Comparing Effectiveness Two Intratissue Percutaneous Electrolysis (EPI) Interventions for Chronic Low Back Pain: Lumbar Nerve Root Stimulation vs Trigger Points Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Intratissue Percutaneous Electrolysis
Trigger points
Lumbar nerve root
Randomized clinical trial
Electrical dry needling
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 64
Sex: ALL
Minimum age (years): 30
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Algometry
timeFrame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
measure: Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
timeFrame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Secondary outcomes:
measure: Change from baseline in disability. Oswestry Low Back Pain Disability Idex.
timeFrame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
measure: Change from baseline in pain intensity. Visual analogue scale.
timeFrame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
measure: Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.
timeFrame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
measure: Change from baseline on Quality of Life. SF-36 Health questionnaire.
timeFrame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
measure: Change from Mcquade Test.
timeFrame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
measure: Change from baseline in range of motion and lumbar segmental mobility
timeFrame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
measure: Change from baseline in Fingers-floor distance (cm)
timeFrame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
measure: Change from baseline in Quality of Sleep . Pittsburgh Quality of Sleep Questionnaire Index
timeFrame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
measure: Change from baseline in Anxiety. Hospital Anxiety and Depression Scale (HADS)
timeFrame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Universidad de Almeria
state: Almeria
Study officials:
References:
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.
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.
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.
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.
citation: 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.
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.
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.
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.
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.
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.
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.
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.