Electrolysis in Patients With Low Back Pain

NCT06661070 | Not Yet Recruiting

• 2 other identifiers: UCM#1#19/044
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain

Keywords

Low Back; Pain; Multifidus muscle; Trigger Points; shear-wave elastography; pain sensitivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pressure Pain Threshold

  Baseline, immediately after, and 24 after of intervention

• Muscle stiffness

  Baseline, immediately after, and 24 after of intervention

Study Arms (3)

High-intensity percutaneous electrolysis (HIPE)

EXPERIMENTAL

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

Device: Electrolysis Percutaneous Therapeutic (EPTE)

Low-intensity percutaneous electrolysis (LIPE)

EXPERIMENTAL

The LIPE group receives a 220 mA × 30 s.

Device: Electrolysis Percutaneous Therapeutic (EPTE)

Dry Needling (DN)

ACTIVE COMPARATOR

The DN group received no galvanic current.

Other: Dry Needling

Interventions

Electrolysis Percutaneous Therapeutic (EPTE) DEVICE

EPTE device (Ionclinics, Valencia, Spain)

High-intensity percutaneous electrolysis (HIPE); Low-intensity percutaneous electrolysis (LIPE)

Dry Needling OTHER

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

Dry Needling (DN)

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead
• Universidad Complutense de Madrid: collaborator
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Faculty of Nursery, Physiotherapy and Podiatry

Madrid, 28040, Spain

Location

Related Publications (3)

• 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.

  PMID: 29037648 RESULT

• 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.

  PMID: 29025044 RESULT

• 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.

  PMID: 34754834 RESULT

MeSH Terms

Conditions

Low Back Pain; Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Juan Antonio Valera-Calero, PhD

  Universidad Complutense de Madrid

  STUDY DIRECTOR

Central Study Contacts

Sebastian Klich, PhD, DSc

CONTACT

+48713473176; sebastian.klich@awf.wroc.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A triple-blinded, pilot randomized controlled trial

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 28, 2024
• Study Start: November 4, 2024
• Primary Completion: November 23, 2024
• Study Completion: November 23, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)