An interventional study of Dry Needling with Vibration + Exercise and Conventional Dry Needling + Exercise in Low Back Pain, Dry Needling and Trigger Points, sponsored by Universidad de Zaragoza. Not yet recruiting at 2 sites in Spain. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Universidad de Zaragoza · Not applicable, Interventional, and Treatment
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.
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.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 108 is above the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Universidad de Zaragoza is the lead sponsor of 111 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Other: Dry Needling with Vibration + Exercise
Participants will receive one session of conventional dry needling, followed by a structured exercise programme (3 sessions/week for 4 weeks).
Other: Conventional Dry Needling + Exercise
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.
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.
Nonspecific Low Back Pain (Numeric Pain Rating Scale)
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.
Time frame: 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.
Acceptability
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.
Time frame: 72 hours post-treatment
Pain During the Intervention
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.
Time frame: Immediately post-treatment
Post-Needling Soreness
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.
Time frame: Immediately, 24, 48, and 72 hours post-treatment
Functional Disability (Roland-Morris Disability Questionnaire)
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.
Time frame: 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)
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.
Time frame: This variable will be measured immediately before the intervention, and 1 and 4 weeks after intervention.
Pressure Pain Threshold (PPT) (algometry)
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.
Time frame: 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)
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).
Time frame: 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)
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.
Time frame: 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)
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."
Time frame: 1 week and 4 weeks after the intervention
Other adverse effects
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.
Time frame: 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)
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.
Time frame: Data collection will occur during treatment administration, specifically during dry needling or dry needling+vibration procedures.
Direct and Indirect Economic Costs
Both direct and indirect costs related with the two studied interventions will be recorded for future cost-efectiveness analysis
Time frame: 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.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Once research has been published
Access criteria: Study protocol will be publish in a scientific journal.
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