Clinical trial NCT06661070: Electrolysis in Patients With Low Back Pain
Official title: Short-term Effectiveness of High- and Low-intensity Percutaneous Electrolysis in Patients With Low Back Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back
Pain
Multifidus muscle
Trigger Points
shear-wave elastography
pain sensitivity
Lead sponsor: Wroclaw University of Health and Sport Sciences
Sponsor class: OTHER
Collaborators: name: Universidad Complutense de Madrid
name: Universidad Rey Juan Carlos
First posted: 2024-10-28
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A triple-blinded, pilot randomized controlled trial
Primary purpose: TREATMENT

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".

Eligibility criteria: 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).

Primary outcomes:
measure: Pain changes in pain intensity before and after the intervention
timeFrame: Baseline, immediately after, and 24 after of intervention
Secondary outcomes:
measure: Pressure Pain Threshold
timeFrame: Baseline, immediately after, and 24 after of intervention
measure: Muscle stiffness
timeFrame: Baseline, immediately after, and 24 after of intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Faculty of Nursery, Physiotherapy and Podiatry
Study officials:
affiliation: Universidad Complutense de Madrid
name: Juan Antonio Valera-Calero, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.