Electrolysis in Patients With Low Back Pain

Not Applicable

Not yet recruiting

• Conditions: Low Back Pain

• Registration Number: NCT06661070
• Lead Sponsor: Wroclaw University of Health and Sport Sciences

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.

Detailed 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".

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-18
• Study First Submitted QC: 2024-10-24
• Last Update Submitted: 2024-10-24
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-28
• Study Start: 2024-11-04
• Primary Completion: 2024-11-23
• Study Completion: 2024-11-23

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain changes in pain intensity before and after the intervention	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 Outcome Measures

Name	Time	Method
Muscle stiffness	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).
Pressure Pain Threshold	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.

Trial Locations

Locations (1)

Faculty of Nursery, Physiotherapy and Podiatry; 🇪🇸 Madrid, Spain