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Efeito do Dry Needling Plus Vibration em pontos-gatilho miofasciais em indivíduos com dor lombar inespecífica (DryNeed+Vib)

29 de setembro de 2026 atualizado por: Alberto Carcasona Otal, Universidad de Zaragoza

Effectiveness and Acceptability of Adding a Percutaneous Vibratory Stimulus to Dry Needling for the Treatment of Myofascial Trigger Points in Individuals With Nonspecific Low Back Pain: A Randomized Non-Inferiority Trial

This study evaluates whether adding mechanical vibration to dry needling (DN+V) is not inferior to dry needling alone (DN) for reducing low back pain intensity in adults with nonspecific low back pain (NSLBP), when both interventions are combined with a structured exercise program.

The primary hypothesis is non-inferiority in pain reduction (Numeric Pain Rating Scale, NPRS) at 1 week after treatment, using a non-inferiority margin of 1 point on the 0-10 NPRS scale. If non-inferiority is confirmed, secondary analyses will explore whether DN+V is superior to DN alone in patient-reported treatment acceptability, pain experienced during the intervention, and post-needling soreness.

Participants will be randomly assigned to one of two parallel groups: DN plus exercise, or DN+V plus exercise. Outcomes will be assessed at baseline and at multiple time points up to 4 weeks after treatment, including pain intensity, disability, acceptability, muscle strength, pressure pain threshold, quality of life, and global impression of change. Direct and indirect costs associated with both interventions will also be collected to provide data for a future economic evaluation of the cost-effectiveness of DN+V compared with DN.

Visão geral do estudo

Descrição detalhada

Low back pain is highly prevalent and a leading cause of disability. Dry needling (DN) is commonly used in physical therapy for musculoskeletal pain, but patient experience during and after treatment (procedural pain, post-needling soreness, and overall acceptability) can limit adherence and satisfaction. This trial investigates whether combining DN with mechanical vibration (DN+V) can maintain the analgesic effect of DN alone while improving the patient experience.

Participants with nonspecific low back pain (NSLBP) will be randomized 1:1 to two parallel groups: (1) DN plus a structured exercise program, or (2) DN+V plus the same exercise program. The exercise program is identical in both arms and has been deliberately kept simple (approximately 3 sessions per week) to preserve sensitivity for detecting between-group differences attributable to the needling intervention itself, while supporting adherence and reflecting standard clinical practice.

The primary hypothesis is non-inferiority: DN+V will not produce a clinically meaningfully worse reduction in low back pain (NPRS, 0-10) compared with DN alone, assessed at 1 week post-treatment. The non-inferiority margin (1 point) was informed by the minimal clinically important difference for NPRS in low back pain reported in the literature and by the estimated treatment effect of DN versus sham DN in prior randomized trials. The primary analysis will use ANCOVA adjusting for baseline NPRS, comparing the upper bound of the two-sided 95% confidence interval for the adjusted mean difference against the non-inferiority margin. Both intention-to-treat and per-protocol analyses will be conducted, given the importance of consistency between these two populations in non-inferiority trials.

If non-inferiority is established, a pre-specified hierarchical (gatekeeping) sequence of secondary superiority hypotheses will be tested in the following order: (1) treatment acceptability (measured with a purpose-built Acceptability Scale at 72 hours); (2) pain experienced during the intervention (NPRS, immediately post-treatment); (3) post-needling soreness (NPRS, assessed immediately and at 24, 48, and 72 hours, analyzed with a mixed model for repeated measures); and (4) an exploratory analysis of superiority in low back pain reduction (NPRS at 1 week).

Additional outcomes collected at multiple time points up to 1 month post-intervention include functional disability (Roland-Morris Disability Questionnaire), muscle strength (dynamometry), electromyographic activity, pressure pain threshold (algometry), health-related quality of life (SF-36), and the Global Rating of Change scale. Longitudinal outcomes will be analyzed with mixed models for repeated measures under a missing-at-random assumption, with sensitivity analyses planned if warranted by the amount or pattern of missing data.

Tipo de estudo

Intervencional

Inscrição (Estimado)

108

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

    • Zaragoza
      • Zaragoza, Zaragoza, Espanha, 50009
        • Universidad de Zaragoza
        • Contato:
          • Universidad de Zaragoza
          • Número de telefone: +34976761749
          • E-mail: sfcs@unizar.es
        • Investigador principal:
          • Alberto Carcasona, Physiotherapist
        • Investigador principal:
          • Pablo Herrero, Physiotherapist
      • Zaragoza, Zaragoza, Espanha
        • Centro de Salud Seminario
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

35 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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).

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Dry needling with vibration + Exercise

Participants will receive one session of dry needling combined with a mechanical vibratory stimulus, followed by a structured exercise programme (3 sessions/week for 4 weeks).

Participants will receive one session of dry needling combined with vibratory stimulation, plus a structured exercise programme (3 sessions/week for 4 weeks).

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.

Comparador Ativo: Conventional dry needling + Exercise

Participants will receive one session of conventional dry needling, followed by a structured exercise programme (3 sessions/week for 4 weeks).

Participants will receive one session of conventional dry needling, plus the same structured exercise programme as the experimental group (3 sessions/week for 4 weeks).

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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Nonspecific Low Back Pain (Numeric Pain Rating Scale)
Prazo: This variable will be measured immediately before the intervention, immediately after the intervention, at 24 hours, 48 hours, 72 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, 72 hours, 1 week, and 4 weeks.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Acceptability
Prazo: 72 hours post-treatment

Patient-reported acceptability of the assigned treatment, measured with a purpose-developed Acceptability Scale. This scale is scored as a percentage, with 100% indicating the highest level of acceptability and 0% indicating the lowest.

72 hours post-treatment
Pain During the Intervention
Prazo: Immediately post-treatment

Pain intensity experienced during the needling procedure, measured with the Numeric Pain Rating Scale (NPRS). This scale ranges from 0 to 10, where "0" indicates no pain and "10" represents the worst possible pain intensity.

Immediately post-treatment
Post-Needling Soreness
Prazo: Immediately, 24, 48, and 72 hours post-treatment

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 with the Numeric Pain Rating Scale (NPRS). This scale ranges from 0 to 10, where "0" indicates no pain and "10" represents the worst possible pain intensity.

Immediately, 24, 48, and 72 hours post-treatment

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Functional Disability (Roland-Morris Disability Questionnaire)
Prazo: Evaluation times will be immediately before the intervention and 72 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 72 hours, 1 week, and 4 weeks after intervention.
Quality of Life (Short Form-36 Questionnaire)
Prazo: This variable will be measured immediately before 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, and 1 and 4 weeks after intervention.
Pressure Pain Threshold (PPT) (algometry)
Prazo: This variable will be measured immediately before the intervention, immediately after the intervention, at 72 hours 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, at 72 hours and at 1 and 4 weeks.
Surface Electromyography (EMG)
Prazo: This variable will be measured immediately before the intervention, immediately after the intervention, at 72 hours, 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, at 72 hours, and at 1 and 4 weeks.
Maximal Isometric Strength (dynamometry)
Prazo: Measurements will be conducted immediately before the intervention, immediately after the intervention, at 72 hours, 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, at 72 hours, and at 1 and 4 weeks after the intervention
Global Rating of Change (GROC)
Prazo: 1 week and 4 weeks after the intervention

The Global Rating of Change (GROC) is a simple, single-item patient-reported outcome measure used to quantify a patient's perceived improvement or deterioration in their health condition over time. Patients rate on a scale from -7 to +7, where -7 indicates "a very great deal worse" and +7 indicates "a very great deal better."

1 week and 4 weeks after the intervention
Other adverse effects
Prazo: Adverse events will be recorded throughout all study assessment time points: immediately after treatment and at 24, 48, and 72 hours, and 1 and 4 weeks post-treatment.

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 throughout all study assessment time points: immediately after treatment and at 24, 48, and 72 hours, and 1 and 4 weeks post-treatment.
Local Twitch Response (Physiological parameter)
Prazo: Data collection will occur during treatment administration, specifically during dry needling or dry needling+vibration procedures.

A local twitch response (LTR) is a brief, involuntary contraction of a tight band of muscle fibers that happens when a trigger point is stimulated with the needle.

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 The physical therapist performing the interventions will be responsible for recording the number of local twitch responses elicited during the intervention.

Data collection will occur during treatment administration, specifically during dry needling or dry needling+vibration procedures.
Direct and Indirect Economic Costs
Prazo: It will be recorded throughout all study assessment time points: before treatment, immediately after treatment and at 24, 48, and 72 hours, and 1 and 4 weeks post-treatment.

Both direct and indirect costs related with the two studied interventions will be recorded for future cost-efectiveness analysis

It will be recorded throughout all study assessment time points: before treatment, immediately after treatment and at 24, 48, and 72 hours, and 1 and 4 weeks post-treatment.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Diretor de estudo: Pablo Herrero, Universidad de Zaragoza

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de dezembro de 2026

Conclusão Primária (Estimado)

1 de janeiro de 2027

Conclusão do estudo (Estimado)

1 de julho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

4 de julho de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de julho de 2024

Primeira postagem (Real)

30 de julho de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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.

Prazo de Compartilhamento de IPD

Once research has been published

Critérios de acesso de compartilhamento IPD

Study protocol will be publish in a scientific journal.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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