Electrolysis in Patients With Low Back Pain

Wroclaw University of Health and Sport Sciences

Status: Not yet enrolling

Conditions: Low Back Pain

Treatments: Device: Electrolysis Percutaneous Therapeutic (EPTE); Other: Dry Needling

Study type: Interventional

Funder types: Other

Identifiers

NCT06661070

UCM#1

#19/044 (Other Identifier)

Details and patient eligibility

About

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.

Full 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".

Enrollment: 50 estimated patients

Sex: All

Ages: 35 to 50 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 3 patient groups

High-intensity percutaneous electrolysis (HIPE)

Experimental group

Description:

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

Treatment:

Device: Electrolysis Percutaneous Therapeutic (EPTE)

Low-intensity percutaneous electrolysis (LIPE)

Experimental group

Description:

The LIPE group receives a 220 mA × 30 s.

Treatment:

Device: Electrolysis Percutaneous Therapeutic (EPTE)

Dry Needling (DN)

Active Comparator group

Description:

The DN group received no galvanic current.

Treatment:

Other: Dry Needling