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NCT Number: NCT06527339

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

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.

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Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Salud Seminario, Zaragoza, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

Primary outcomes

  1. 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.

    This variable refers to the participants' low back pain at the time of the assessment. It does not include the pain caused by the treatment itself. 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.

  2. Pain intensity during treatment (Numeric Pain Rating Scale)

    Time frame: This variable will only be measured immediately after the treatment.

    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).

  3. Post-needle pain / post-treatment pain (Numeric Pain Rating Scale)

    Time frame: 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.

    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.

  4. Acceptability of receiving percutaneous treatment (Acceptability Scale)

    Time frame: Evaluations will be performed immediately after intervention and within 48 hours

    It will be evaluated using a specific qualitative scale developed explicitly for this project. It is a scale which adopts a holistic approach, prioritizing two key variables, "pain during the treatment" and "post-needling pain," as the primary determinants of the overall score. However, other factors, such as emotional experience, physical state, satisfaction level, and environmental influence, will also be considered.

Secondary outcomes

  1. Functional Disability (Roland-Morris Disability Questionnaire)

    Time frame: Evaluation times will be immediately before the intervention and 48 hours, 1 week, and 4 weeks after intervention.

    Functional disability will be assessed using the Roland-Morris Disability Questionnaire (RMDQ), a tool designed to measure physical disability caused by low back pain. The questionnaire consists of 24 items, with scores ranging from 0 (no limitations) to 24 (maximum possible disability), evaluating limitations in various daily life activities.

  2. Maximal Isometric Strength (dynamometry)

    Time frame: Measurements will be conducted immediately before the intervention, immediately after the intervention, and at 1 and 4 weeks after the intervention

    This variable will be measured using the "microFET-2 dynamometer". Muscles assessed will include the lumbar erector spinae, multifidus muscles, and hip abductor musculature. Participants' weight will be recorded to normalize the collected data. Three maximal isometric contractions will be performed, each lasting 5 seconds, with a 1-minute rest period between them. The average of these measurements will be used for statistical analysis.

  3. Surface Electromyography (EMG)

    Time frame: This variable will be measured immediately before the intervention, immediately after the intervention, and at 1 and 4 weeks.

    It will be recorded using mDurance equipment. For each measurement, the amplitude of the electromyographic activity (measured in microvolts -mV-) of the target musculature at rest will first be recorded for 10 seconds. Then, the muscle activation level during maximal isometric contraction will be recorded to normalize the electromyographic signal. This will follow the same methodology as the maximal isometric strength variable (three maximal isometric contractions of 5 seconds each, with 30 seconds of rest). In this case, the parameter of interest will be the signal's peak amplitude. Lastly, 10 dynamic repetitions of the functional movement "front squat" will be evaluated. This data will determine the percentage of muscle activation relative to maximal isometric contractions, known as the "percentage of maximal voluntary isometric contraction" (%MVIC).

  4. Pressure Pain Threshold (PPT) (algometry)

    Time frame: This variable will be measured immediately before the intervention, immediately after the intervention, and at 1 and 4 weeks.

    PPT will be assessed using a digital algometer (Somedic SenseLab, Suecia) with a 1 cm² rubber tip. The pressure will be applied perpendicularly to the skin at a constant rate of 0.5 kg/s until the participant reports that the pressure sensation changes to pain. To differentiate between peripheral and central mechanisms, measurements will be taken at two locations: 1) Locally, directly over the treated MTrP in the lumbar region (peripheral sensitization), and 2) Distally, at a remote site such as the tibialis anterior muscle (central sensitization). Before the actual tests, the PPT will be familiarized by applying it to the participant's dominant arm until the participant becomes familiar with the test procedure. Three measurements will be taken at each site, but not at precisely the same point to avoid influencing the pain threshold from previous measurements, with a 30-second rest interval, and the mean value will be used for statistical analysis.

  5. Quality of Life (Short Form-36 Questionnaire)

    Time frame: This variable will be measured immediately before the intervention, 48 hours after the intervention, and 1 and 4 weeks after intervention.

    The Short Form-36 Questionnaire will be used to assess this variable. This survey comprises 36 questions about general health. The questionnaire consists of eight subscales (physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health), summarized into two scores: physical and psychological health. Scores range from 0 to 100% and reflect self-perceived health-related quality of life.

Other outcomes

  1. Local Twitch Response

    Time frame: Data collection will occur during the intervention period.

    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.

  2. Other adverse effects

    Time frame: Adverse events will be recorded whenever reported by the participant.

    We hypothesize that DN+V, being less aggressive than DN, will reduce the risk of adverse effects associated with DN (hematomas, bleeding, pain, dizziness, etc.) Adverse effects will not be included in the statistical analysis; however, these data will provide valuable descriptive information, given that adverse events are often underreported in research despite their clinical relevance.

Study contacts

Contact information is provided by the study sponsor or research team.

Alberto Carcasona

CONTACT

[email protected]

+34666387648

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2024
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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