Electrolysis in Patients With Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electrolysis Percutaneous Therapeutic (EPTE), Dry Needling.
- Who it may be relevant to
- Registry conditions: Low Back Pain. Basic parameters: 35 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Short-term Effectiveness of High- and Low-intensity Percutaneous Electrolysis in Patients With Low Back Pain
Overview
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".
Interventions
- Device Electrolysis Percutaneous Therapeutic (EPTE)
EPTE device (Ionclinics, Valencia, Spain) - Other Dry Needling
A dry needle with size 0.30 × 40 (Agupunt, Barcelona, Spain)
Primary outcome measures
- Pain changes in pain intensity before and after the intervention [Time frame: Baseline, immediately after, and 24 after of intervention]
Secondary outcome measures (2)
- Pressure Pain Threshold [Time frame: Baseline, immediately after, and 24 after of intervention]
- Muscle stiffness [Time frame: Baseline, immediately after, and 24 after of intervention]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Faculty of Nursery, Physiotherapy and Podiatry — Madrid
Publications
- 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. PMID 29037648
- 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. PMID 29025044
- 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. PMID 34754834
Identifiers
NCT: NCT06661070 · UCM#1 · #19/044