Effect of Dry Needling Plus Vibration on Myofascial Trigger Points in Individuals With Nonspecific Low Back Pain

Официальное название

Acceptability and Effectiveness of Adding a Percutaneous Vibratory Stimulus to Dry Needling for the Treatment of Myofascial Trigger Points in Nonspecific Low Back Pain: A Randomized Controlled Trial.

Обзор

Low back pain is one of the most common health issues worldwide, and in most cases, this pain is nonspecific low back pain (NSLBP). NSLBP is characterized by the inability to determine the real source of the pain and commonly presents with myofascial trigger points (MTrPs) in the muscles related to the lumbar region. One of the most widely used techniques for treating NSLBP by targeting MTrPs is dry needling (DN), a technique that involves inserting a needle to produce a mechanical effect capable of "deactivating" the MTrP and thereby alleviating its symptoms. However, some studies have concluded that other techniques are more effective than DN, such as percutaneous electrolysis (PE). When using the PE technique, it appears that adding a galvanic current enhances the effects of DN. Nonetheless, this poses a greater risk to the patient, as the galvanic current could damage nervous tissue if it comes into contact. For this reason, it is proposed to investigate whether other physical agents that are not electrical could enhance the effect of DN without increasing its risk. This is the case for vibration, a stimulus that has already been used successfully for the treatment of MTrPs, allowing us to investigate whether adding vibration to DN introduces therapeutic capabilities that: * Maintain or increase the effectiveness of DN in terms of pain and functional capacity. * Do not add risks for the patient, unlike PE. * Are less painful than DN and cause less post-needling pain than that generated after successive needle insertions with DN. Emphasizing these adverse effects is necessary since most clinical trials do not report these variables, which is fundamental for describing the safety of invasive techniques. Following this idea, the present project will analyze a new invasive therapy for the treatment of MTrPs: dry needling with vibratory stimulus (DN+V), for which the following hypotheses are proposed: * DN+V, instead of using an electrical stimulus like PE that could cause damage to some tissues, will apply vibration to the DN needles to increase the mechanical stimulus exerted on the MTrP, expecting greater benefits in terms of pain, functional capacity, muscle strength, and other variables of interest in individuals with NSLBP, and possibly requiring less treatment time than DN. * In DN, the repeated insertions and withdrawals of the needle in the MTrP provoke a hemorrhagic and inflammatory reaction that translates into hypersensitivity and microscopic tissue injury in the muscle, causing pain during treatment and post-needling pain for the following 24-32 hours. Another study showed that PE caused less post-needling pain than DN, which may be due to the fact that, unlike DN, it is common in PE to only perform a single puncture with each needle and not mobilize them. * The methodology for DN+V will be the same as for PE, with a single puncture and no needle manipulation, so it is expected that DN+V, being less invasive than DN, will reduce pain during treatment and post-needling pain compared to that generated by DN. There are studies that support this hypothesis, concluding that needle manipulation in DN produces greater post-needling pain than DN without needle manipulation.

Подробное описание

This study aims to evaluate the acceptability and effectiveness of a new invasive therapy for treating MTrPs: dry needling with vibratory stimulus (DN+V). The following hypotheses are proposed:

* DN+V will utilize vibration on the dry needling needles instead of an electrical stimulus like in percutaneous electrolysis (PE), which could potentially damage some tissues. The expectation is that DN+V will increase the mechanical stimulus applied to the MTrP, yielding greater benefits in terms of pain relief, functional capacity, muscle strength, and other variables of interest in individuals with NSLBP, possibly requiring less treatment time compared to DN alone. * In DN, repeated insertions and withdrawals of the needle into the MTrP provoke a hemorrhagic and inflammatory reaction that results in hypersensitivity and microscopic tissue injury in the muscle, causing pain during treatment and post-needling pain for the next 24-32 hours. A study showed that PE caused less post-needling pain than DN, likely because PE typically involves a single puncture per needle without needle manipulation. * DN+V will follow the same methodology as PE, with a single puncture and no needle manipulation. Thus, it is expected that DN+V, being less invasive than DN, will reduce pain during treatment and post-needling pain compared to DN. A study supports this hypothesis, concluding that needle manipulation in DN produces greater post-needling pain than DN without needle manipulation.

To test these hypotheses, a randomized clinical trial will be conducted: "RCT: Analysis of the Effectiveness on Pain in Individuals with Nonspecific Low Back Pain by Adding a Percutaneous Vibratory Stimulus to Dry Needling in the Treatment of MTrPs."

EXPECTED RESULTS This initial study will provide the first data on DN+V, focusing on whether DN+V is easy to apply, well-tolerated by patients, and shows effects similar to or better than DN in reducing NSLBP.

METHODOLOGY

* Instrumentation and Evaluation Method: A group of specialized physiotherapists will evaluate each participant for MTrPs in muscles related to NSLBP. Identified MTrPs will be included in the study. * Variables: The following variables will be assessed: Pain intensity during the treatment, Post-needling pain/sensitization, Acceptability, Other adverse effects, Low back pain intensity, Functional Disability, Maximal Isometric Strength, Electromyography, Pressure Pain Threshold, Quality of Life. * Intervention: Participants will be randomized into 2 groups:

1. Standard DN (multiple insertions) during 1.5 minutes + exercises (considered the control group) 2. DN+V (single insertion) at the maximum tolerable vibration intensity, always inside the maximum intensity (5 volts) produced by the vibration device, + exercises.

Вмешательства

• Другое Dry Needling with Vibration + exercises
  Participants will receive dry needling combined with vibratory stimulation. A sterile acupuncture needle will be inserted into the affected muscle(s) and, once correctly positioned, will remain stationary throughout the intervention. Vibratory stimulation will then be applied to the needle for 60 seconds at the maximum intensity tolerated by the participant, up to a maximum output of 5 V. In relation to the exercise program, participants will complete a protocol based on core stabilization and
• Другое Conventional Dry Needling + exercises
  Participants will receive conventional dry needling. A sterile acupuncture needle will be inserted into the affected muscle(s), and the intervention will consist of the "fast in-and-out" technique described by Hong (1994), performed at an approximate frequency of one insertion per second (1 Hz) without completely withdrawing the needle from the skin. The technique will be applied for up to 60 seconds with the aim of eliciting local twitch responses. However, the procedure may be discontinued at

Первичные конечные точки

• Nonspecific Low Back Pain (Numeric Pain Rating Scale) [Срок оценки: This variable will be measured immediately before the intervention, immediately after the intervention, at 24 hours, 48 hours, 1 week, and 4 weeks.]
• Pain intensity during treatment (Numeric Pain Rating Scale) [Срок оценки: This variable will only be measured immediately after the treatment.]
• Post-needle pain / post-treatment pain (Numeric Pain Rating Scale) [Срок оценки: 24 and 48 hours after the intervention. This approach will allow for the assessment of the duration and intensity of the pain/discomfort caused by the needle puncture.]
• Acceptability of receiving percutaneous treatment (Acceptability Scale) [Срок оценки: Evaluations will be performed immediately after intervention and within 48 hours]

Вторичные конечные точки (5)

• Functional Disability (Roland-Morris Disability Questionnaire) [Срок оценки: Evaluation times will be immediately before the intervention and 48 hours, 1 week, and 4 weeks after intervention.]
• Maximal Isometric Strength (dynamometry) [Срок оценки: Measurements will be conducted immediately before the intervention, immediately after the intervention, and at 1 and 4 weeks after the intervention]
• Surface Electromyography (EMG) [Срок оценки: This variable will be measured immediately before the intervention, immediately after the intervention, and at 1 and 4 weeks.]
• Pressure Pain Threshold (PPT) (algometry) [Срок оценки: This variable will be measured immediately before the intervention, immediately after the intervention, and at 1 and 4 weeks.]
• Quality of Life (Short Form-36 Questionnaire) [Срок оценки: This variable will be measured immediately before the intervention, 48 hours after the intervention, and 1 and 4 weeks after intervention.]

Критерии участия

Критерии включения

• Individuals with NSLBP: pain persisting for more than six weeks, located between the twelfth rib and the buttocks, and scoring at least 3 points on the Numeric Pain Rating Scale;
• Presence of MTrPs in any of the following muscles that are associated with low back pain (erector spinae muscles, longissimus, iliocostalis, multifidus, gluteus maximus, gluteus medius, and quadratus lumborum);
• Aged between 35-65 years: this population exhibits the highest prevalence of low back pain and consequently represents the greatest socio-economic impact on society;
• Having signed the informed consent form.

Критерии исключения

• Diagnosis of specific pathologies associated with low back pain (e.g., herniated discs, neurological disorders);
• Any form of infiltration within the past 3 months;
• Having received any physiotherapy interventions in the lumbopelvic region within the past 4 weeks;
• History of surgical intervention in the lumbopelvic region;
• Use of anticoagulant or antiplatelet medications within the last week;
• Presence of systemic or local lumbar infections;
• Pregnancy;
• Fear of needles (belonephobia).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 2 центра

• Universidad de Zaragoza — Zaragoza
• Centro de Salud Seminario — Zaragoza

Идентификаторы

NCT: NCT06527339 · DN+V vs DN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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