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

Sponsor
Universidad de Zaragoza
Study ID
NCT06527339
Status
Not Yet Recruiting

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Conditions

  • Dry Needling
  • Low Back Pain
  • Trigger Points
  • Vibration

Eligibility Criteria

Sex
ALL
Age
35 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Dry Needling with Vibration + exercises — OTHER
    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 lumbar strengthening, and will be performed twice per week for 4 weeks.
  • Conventional Dry Needling + exercises — OTHER
    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 the participant's request if it becomes intolerably painful. In such cases, the actual duration of the intervention will be recorded. In relation to the exercise program, participants will complete a protocol based on core stabilization and lumbar strengthening, and will be performed twice per week for 4 weeks.

Study Details

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.

Key Dates

First listed
Jul 30, 2024
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dry needling with vibration + exercises
    Participants will receive dry needling combined with vibratory stimulation + exercises
  • Active Comparator: Conventional dry needling + exercises
    Participants will receive conventional dry needling + exercises

Primary Outcome Measure

Nonspecific Low Back Pain (Numeric Pain Rating Scale) [ Time Frame: This variable will be measured immediately before the intervention, immediately after the intervention, at 24 hours, 48 hours, 1 week, and 4 weeks. ]

Central Contacts

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