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| ID | Type | Description | Link |
|---|---|---|---|
| #19/044 | Other Identifier | Clinical Ethics Committee of Hospital Clínico San Carlos |
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| Name | Class |
|---|---|
| Universidad Complutense de Madrid | OTHER |
| Universidad Rey Juan Carlos | OTHER |
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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.
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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-intensity percutaneous electrolysis (HIPE) | Experimental | The HIPE group receives a 660 mA galvanic current for 10 s. |
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| Low-intensity percutaneous electrolysis (LIPE) | Experimental | The LIPE group receives a 220 mA × 30 s. |
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| Dry Needling (DN) | Active Comparator | The DN group received no galvanic current. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrolysis Percutaneous Therapeutic (EPTE) | Device | EPTE device (Ionclinics, Valencia, Spain) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, immediately after, and 24 after of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, immediately after, and 24 after of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastian Klich, PhD, DSc | Contact | +48713473176 | sebastian.klich@awf.wroc.pl |
| Name | Affiliation | Role |
|---|---|---|
| Juan Antonio Valera-Calero, PhD | Universidad Complutense de Madrid | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Nursery, Physiotherapy and Podiatry | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29037648 | Result | 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. | |
| 29025044 | Result | 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. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000079245 | Dry Needling |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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A triple-blinded, pilot randomized controlled trial
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| Dry Needling | Other | A dry needle with size 0.30 × 40 (Agupunt, Barcelona, Spain) |
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| 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). | Baseline, immediately after, and 24 after of intervention |
| 34754834 | Result | 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. |