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

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ultrasound-guided percutaneous electrolysis in the lumbar nerve root
Electrical Dry Needling in trigger points
Sponsored by
Universidad de Almeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Intratissue Percutaneous Electrolysis, Trigger points, Lumbar nerve root, Randomized clinical trial, Electrical dry needling

Eligibility Criteria

30 Years - 67 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Universidad de Almeria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Percutaneous electrolysis in the lumbar nerv

Electrical dry needling in trigger points

Arm 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 / 3 weeks). The intervention will be guided by ultrasound equipment medically certified (Directive 93/42 / EEC) device (EPI Advanced Medicine, Barcelona, Spain).

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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
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.
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.
Change from Mcquade Test.
It measures the isometric endurance of trunk flexion muscles.
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.
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.

Full Information

First Posted
February 26, 2020
Last Updated
September 20, 2023
Sponsor
Universidad de Almeria
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1. Study Identification

Unique Protocol Identification Number
NCT04290221
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
March 4, 2022 (Actual)
Study Completion Date
June 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Intratissue Percutaneous Electrolysis, Trigger points, Lumbar nerve root, Randomized clinical trial, Electrical dry needling

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Percutaneous electrolysis in the lumbar nerv
Arm Type
Experimental
Arm 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 / 3 weeks). The intervention will be guided by ultrasound equipment medically certified (Directive 93/42 / EEC) device (EPI Advanced Medicine, Barcelona, Spain).
Arm Title
Electrical dry needling in trigger points
Arm Type
Active Comparator
Arm 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).
Intervention Type
Other
Intervention Name(s)
Ultrasound-guided percutaneous electrolysis in the lumbar nerve root
Intervention 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 (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).
Intervention Type
Other
Intervention Name(s)
Electrical Dry Needling in trigger points
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from baseline in Algometry
Description
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.
Time Frame
At baseline, at 1 week after the last intervention, and 1-month follow-up period.
Title
Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
Description
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.
Time Frame
At baseline, at 1 week after the last intervention, and 1-month follow-up period.
Secondary Outcome Measure Information:
Title
Change from baseline in disability. Oswestry Low Back Pain Disability Idex.
Description
It has 10 items associated to activities of daily living, each item has a punctuation from 0 to 5 points.
Time Frame
At baseline, at 1 week after the last intervention, and 1-month follow-up period.
Title
Change from baseline in pain intensity. Visual analogue scale.
Description
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain
Time Frame
At baseline, at 1 week after the last intervention, and 1-month follow-up period.
Title
Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.
Description
Is a 17-item questionnaire that measures the fear of movement and (re)injury.
Time Frame
At baseline, at 1 week after the last intervention, and 1-month follow-up period.
Title
Change from baseline on Quality of Life. SF-36 Health questionnaire.
Description
SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.
Time Frame
At baseline, at 1 week after the last intervention, and 1-month follow-up period.
Title
Change from Mcquade Test.
Description
It measures the isometric endurance of trunk flexion muscles.
Time Frame
At baseline, at 1 week after the last intervention, and 1-month follow-up period.
Title
Change from baseline in range of motion and lumbar segmental mobility
Description
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.
Time Frame
At baseline, at 1 week after the last intervention, and 1-month follow-up period.
Title
Change from baseline in Fingers-floor distance (cm)
Description
The patient flexes the trunk forward from the standing position, and the distance from the fingers to the ground is measured.
Time Frame
At baseline, at 1 week after the last intervention, and 1-month follow-up period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Universidad de Almeria
City
Almería
State/Province
Almeria
ZIP/Postal Code
04120
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
29777953
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.
Results Reference
background
PubMed Identifier
20193941
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.
Results Reference
background
PubMed Identifier
28480978
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.
Results Reference
background
PubMed Identifier
27517512
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.
Results Reference
background
PubMed Identifier
24477495
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.
Results Reference
background
PubMed Identifier
28931976
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.
Results Reference
background
PubMed Identifier
29436233
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.
Results Reference
background
PubMed Identifier
18787845
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.
Results Reference
background
PubMed Identifier
31513095
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.
Results Reference
background
PubMed Identifier
27676689
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.
Results Reference
background
PubMed Identifier
26649058
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.
Results Reference
background
PubMed Identifier
25122629
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.
Results Reference
background

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

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