Health TrialsbyHealthPanel

Electrolysis in Patients With Low Back Pain

ConditionLow Back Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-50
SponsorWroclaw University of Health and Sport Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Electrolysis Percutaneous Therapeutic (EPTE)

    Device

    EPTE device (Ionclinics, Valencia, Spain)

  • Dry Needling

    Other intervention

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

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: High-intensity percutaneous electrolysis (HIPE)Experimental treatment 1 intervention
Group B: Low-intensity percutaneous electrolysis (LIPE)Experimental treatment 1 intervention
Group C: Dry Needling (DN)Active comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
Baseline, immediately after, and 24 after of intervention
2

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).

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wroclaw University of Health and Sport Sciences

Lead sponsor

Universidad Complutense de Madrid

Collaborator

Universidad Rey Juan Carlos

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: