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

July 8, 2026 updated by: Alberto Carcasona Otal, Universidad de Zaragoza

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
    • Zaragoza
      • Zaragoza, Zaragoza, Spain, 50009
        • Universidad de Zaragoza
        • Contact:
          • Universidad de Zaragoza
          • Phone Number: +34976761749
          • Email: sfcs@unizar.es
        • Principal Investigator:
          • Alberto Carcasona, Physiotherapist
        • Principal Investigator:
          • Pablo Herrero, Physiotherapist
      • Zaragoza, Zaragoza, Spain
        • Centro de Salud Seminario
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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;
  2. 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);
  3. 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;
  4. Having signed the informed consent form.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dry needling with vibration + exercises
Participants will receive dry needling combined with vibratory stimulation + exercises
Other: 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 lumbar strengthening, and will be performed twice per week for 4 weeks.
Active Comparator: Conventional dry needling + exercises
Participants will receive conventional dry needling + exercises
Other: 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 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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)
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).
This variable will only be measured immediately after the treatment.
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.
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)
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.
Evaluations will be performed immediately after intervention and within 48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Evaluation times will be immediately before the intervention and 48 hours, 1 week, and 4 weeks after intervention.
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.
Measurements will be conducted immediately before the intervention, immediately after the intervention, and at 1 and 4 weeks after the intervention
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).
This variable will be measured immediately before the intervention, immediately after the intervention, and at 1 and 4 weeks.
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.
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)
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.
This variable will be measured immediately before the intervention, 48 hours after the intervention, and 1 and 4 weeks after intervention.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Data collection will occur during the intervention period.
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.
Adverse events will be recorded whenever reported by the participant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Zaragoza

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pablo Herrero, Universidad de Zaragoza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DN+V vs DN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared on a reasonable request contacting with the main author once data has been published.

Anyway, Individual participant data (IPD) will be shared with other researchers in accordance with data sharing protocols and participant consent, ensuring confidentiality and ethical considerations are maintained.

IPD Sharing Time Frame

Once research has been published

IPD Sharing Access Criteria

Study protocol will be publish in a scientific journal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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