Electrolysis in Patients With Low Back Pain (Electrolysis)

Short-term Effectiveness of High- and Low-intensity Percutaneous Electrolysis in Patients With Low Back Pain

The goal of this observational study is to investigate the efficacy of percutaneous electrolysis compared with dry needling on pain sensations and multifidus muscle properties in subjects with low back pain. The main questions it aims to answer are:

The high-intensity and low-intensity percutaneous electrolysis may induce pressure pain threshold (PPT) changes in myofascial trigger points in the low back during the intervention compared with dry needling.

Percutaneous electrolysis interventions may reduce stiffness in the multifidus muscle during the intervention compared with dry needling.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Device: Electrolysis Percutaneous Therapeutic (EPTE); Other: Dry Needling

Detailed Description

A parallel-group, controlled, triple-blinded, randomized pilot clinical trial comparing the effects of a single session of high-intensity percutaneous electrolysis (HIPE), low-intensity percutaneous electrolysis (LIPE), and dry needling (DN) applied to the multifidus muscle most active MTrP in subjects with low back pain. This clinical trial will follow the Consolidated Standards of Reporting Trials for pragmatic clinical trials.

This procedure consists of three trials, i.e., (1, HIPE) 660 uA x 30"; (2, LIPE) 220uA x 30"; and (3, DN) with 1 twitch response, and the needle inserted 30".

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sebastian Klich, PhD, DSc; Phone Number: +48713473176; Email: sebastian.klich@awf.wroc.pl

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Faculty of Nursery, Physiotherapy and Podiatry
    • Contact: Juan Antonio Valera-Calero, PhD; Phone Number: +34913941524; Email: juavaler@ucm.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• to report low back pain of at least six months duration,
• aged 35 to 50 years,
• at least one active trigger point is present in the multifidus muscle.

Exclusion Criteria:

• pharmacological (e.g., analgesics) or physiotherapy treatment before or during their participation in the study,
• needle fear,
• prior lower extremity or spine surgery, absence of pain, any musculoskeletal or neuropathic conditions (e.g., peripheral compressive neuropathy, radiculopathy, sarcopenia, fibromyalgia, muscle ruptures), traumatic injuries (e.g., fractures or fissures), or any medical condition or contraindication for needling treatment (e.g., anticoagulants).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-intensity percutaneous electrolysis (HIPE); The HIPE group receives a 660 mA galvanic current for 10 s.	Device: Electrolysis Percutaneous Therapeutic (EPTE); EPTE device (Ionclinics, Valencia, Spain)
Experimental: Low-intensity percutaneous electrolysis (LIPE); The LIPE group receives a 220 mA × 30 s.	Device: Electrolysis Percutaneous Therapeutic (EPTE); EPTE device (Ionclinics, Valencia, Spain)
Active Comparator: Dry Needling (DN); The DN group received no galvanic current.	Other: Dry Needling; A dry needle with size 0.30 × 40 (Agupunt, Barcelona, Spain)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain changes in pain intensity before and after the intervention	A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patient's current level of shoulder pain, and the worst and lowest level of pain experienced in the preceding week in the shoulder area.	Baseline, immediately after, and 24 after of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure Pain Threshold	Somedic Algometer type 2 was used to measure PPT. The diameter of the contact tip was 10 mm and covered with 2 mm thick rubber. The pressure on point and its rate was standardized (30 kPa s-1 ). The value of the pain threshold equals the value of the pressure at which the examined person reported that the pressure exerted on a certain point causes pain.	Baseline, immediately after, and 24 after of intervention
Muscle stiffness	An ultrasound machine with shear-wave elastography Canon Aplio A device, using a linear transducer PLT-1005-BT (Canon Medical Corp, 1385 Shimoishigami, Otawara, Tochigi 324-8550, Japan). The console settings will also be standard for all the acquisitions (Frequency=11 MHz, Gain=78 dB, Dynamic Range=75, and Depth=4.5 cm).	Baseline, immediately after, and 24 after of intervention

Collaborators and Investigators

• Sponsor: Wroclaw University of Health and Sport Sciences
• Collaborators: Universidad Complutense de Madrid; Universidad Rey Juan Carlos
• Investigators: Study Director: Juan Antonio Valera-Calero, PhD, Universidad Complutense de Madrid

Publications and helpful links

General Publications

• Fernandez-de-Las-Penas C, Dommerholt J. International Consensus on Diagnostic Criteria and Clinical Considerations of Myofascial Trigger Points: A Delphi Study. Pain Med. 2018 Jan 1;19(1):142-150. doi: 10.1093/pm/pnx207.
• Rozenfeld E, Finestone AS, Moran U, Damri E, Kalichman L. Test-retest reliability of myofascial trigger point detection in hip and thigh areas. J Bodyw Mov Ther. 2017 Oct;21(4):914-919. doi: 10.1016/j.jbmt.2017.03.023. Epub 2017 Mar 29.
• Valera-Calero JA, Sanchez-Mayoral-Martin A, Varol U. Short-term effectiveness of high- and low-intensity percutaneous electrolysis in patients with patellofemoral pain syndrome: A pilot study. World J Orthop. 2021 Oct 18;12(10):781-790. doi: 10.5312/wjo.v12.i10.781. eCollection 2021 Oct 18.

Study record dates

Study Major Dates

• Study Start (Estimated): November 4, 2024
• Primary Completion (Estimated): November 23, 2024
• Study Completion (Estimated): November 23, 2024

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Low Back; Multifidus muscle; Trigger Points; pain sensitivity; shear-wave elastography
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: UCM#1; #19/044 (Other Identifier: Clinical Ethics Committee of Hospital Clínico San Carlos)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No