Effect of Dry Needling Plus Vibration on Myofascial Trigger Points in Individuals With Nonspecific Low Back Pain
NCT Number: NCT06527339
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Low Back Pain|Dry Needling|Electrolysis|Trigger Points
Interventions: OTHER: Dry Needling with Vibration|OTHER: Conventional Dry Needling
Sponsor: Universidad de Zaragoza
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-05
Locations: Universidad de Zaragoza, Zaragoza, 50009, Spain

Summary:
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.

Primary Outcome Measures: Nonspecific Low Back Pain (Numeric Pain Rating Scale), It refers to the nonspecific low back pain experienced by the study population. The Numeric Pain Rating Scale (NPRS) will be used. This scale ranges from 0 to 10, where "0" indicates no pain and "10" represents the worst possible pain intensity. Patients will select the number that best reflects the intensity of their pain. The NPRS is a widely used, simple scale that offers good sensitivity and provides suitable data for statistical analysis., This variable will be measured before the intervention, immediately after the intervention, at 24 hours, and at 48 hours.|Pain during treatment (Numeric Pain Rating Scale), The NPRS will be used again, but in this case, to assess the pain generated by the treatment itself on the patient. The focus will not be on the non-specific low back pain (NSLBP)., This variable will only be measured immediately after the treatment.|Post-puncture pain / post-treatment pain (Numeric Pain Rating Scale), It is a highly prevalent adverse effect of dry needling. This pain does not refer to that caused by the MTrPs, but rather to that caused by the needling itself.

This variable will be measured using the NPRS once again. The patient will be asked to record the intensity of the post-puncture pain at 12, 24, 36, 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., 12, 24, 36, and 48 hours after the intervention
Other Outcome Measures: Local Twitch Response, When both interventions (dry needling or dry needling + vibration) are applied, it will be noted whether local twitch response has occurred or not. Although this response is not necessary to consider the dry needling treatment applied correctly, and whether or not a local twitch response occurs is not a fundamental aspect of this study, it is deemed appropriate to record this variable for descriptive purposes of the sample and for potential discussion in the findings., Data collection will occur during the intervention period.