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NCT Number: NCT06661070

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.

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Key information

Conditions

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

Age range

35 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Nursery, Physiotherapy and Podiatry

Madrid, 28040, Spain

Location contact

Juan Antonio Valera-Calero, PhD

CONTACT

[email protected]

+34913941524

About this study

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".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Electrolysis Percutaneous Therapeutic (EPTE)

Device

EPTE device (Ionclinics, Valencia, Spain)

dry needling

Other

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

Primary outcomes

  1. Pain changes in pain intensity before and after the intervention

    Time frame: Baseline, immediately after, and 24 after of 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.

Secondary outcomes

  1. Pressure Pain Threshold

    Time frame: Baseline, immediately after, and 24 after of intervention

    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.

  2. Muscle stiffness

    Time frame: Baseline, immediately after, and 24 after of intervention

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sebastian Klich, PhD, DSc

CONTACT

[email protected]

+48713473176

Sponsors and collaborators

Lead sponsor

Wroclaw University of Health and Sport Sciences

Other

Collaborators

  • Universidad Complutense de Madrid
  • Universidad Rey Juan Carlos

Registry information

Official study title

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

Acronym: Electrolysis

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 28, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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