Electrolysis in Patients With Low Back Pain

NCT ID: NCT06661070

Last Updated: 2024-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2024-11-23

Brief Summary

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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.

Detailed Description

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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".

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A triple-blinded, pilot randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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High-intensity percutaneous electrolysis (HIPE)

The HIPE group receives a 660 mA galvanic current for 10 s.

Group Type EXPERIMENTAL

Electrolysis Percutaneous Therapeutic (EPTE)

Intervention Type DEVICE

EPTE device (Ionclinics, Valencia, Spain)

Low-intensity percutaneous electrolysis (LIPE)

The LIPE group receives a 220 mA × 30 s.

Group Type EXPERIMENTAL

Electrolysis Percutaneous Therapeutic (EPTE)

Intervention Type DEVICE

EPTE device (Ionclinics, Valencia, Spain)

Dry Needling (DN)

The DN group received no galvanic current.

Group Type ACTIVE_COMPARATOR

Dry Needling

Intervention Type OTHER

A dry needle with size 0.30 × 40 (Agupunt, Barcelona, Spain)

Interventions

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Electrolysis Percutaneous Therapeutic (EPTE)

EPTE device (Ionclinics, Valencia, Spain)

Intervention Type DEVICE

Dry Needling

A dry needle with size 0.30 × 40 (Agupunt, Barcelona, Spain)

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Complutense de Madrid

OTHER

Sponsor Role collaborator

Universidad Rey Juan Carlos

OTHER

Sponsor Role collaborator

Wroclaw University of Health and Sport Sciences

OTHER

Sponsor Role lead

Responsible Party

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Sebastian Klich

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan Antonio Valera-Calero, PhD

Role: STUDY_DIRECTOR

Universidad Complutense de Madrid

Locations

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Faculty of Nursery, Physiotherapy and Podiatry

Madrid, , Spain

Site Status

Countries

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Spain

Central Contacts

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Sebastian Klich, PhD, DSc

Role: CONTACT

+48713473176

Facility Contacts

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Juan Antonio Valera-Calero, PhD

Role: primary

+34913941524

References

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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.

Reference Type RESULT
PMID: 29037648 (View on PubMed)

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.

Reference Type RESULT
PMID: 29025044 (View on PubMed)

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.

Reference Type RESULT
PMID: 34754834 (View on PubMed)

Other Identifiers

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#19/044

Identifier Type: OTHER

Identifier Source: secondary_id

UCM#1

Identifier Type: -

Identifier Source: org_study_id

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