Low Back PainDryNeed+VibNCT06527339
Effect of Dry Needling Plus Vibration on Myofascial Trigger Points in Individuals With Nonspecific Low Back Pain
A study testing Dry Needling with Vibration + Exercise and Conventional Dry Needling + Exercise in people with Low Back Pain and Dry Needling, run by Universidad de Zaragoza at 2 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Low Back Pain, Dry Needling, Trigger Points
- What is being tested?
- Dry Needling with Vibration + Exercise and Conventional Dry Needling + Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesSpain
- Study dates
- Dec 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites
Universidad de Zaragoza
Zaragoza, Zaragoza, 50009
Universidad de Zaragoza, +34976761749, sfcs@unizar.es
Alberto Carcasona, Physiotherapist
Centro de Salud Seminario
Zaragoza, Zaragoza
Concha Sanz, Physiotherapist, 610804389, conchasr@unizar.es
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Dry Needling with Vibration + Exercise, Conventional Dry Needling + Exercise
- Keywords
- Non-specific low back pain, vibration dry needling, miofascial trigger points, dry needling, trigger point, mechanical vibration, non-inferiority trial, randomized trial, physical therapy, acceptability
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry Needling with Vibration + ExerciseOther
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.
Conventional Dry Needling + ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling with vibration + Exercise | Experimental | 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). Receives: Other: Dry Needling with Vibration + Exercise |
| Conventional dry needling + Exercise | Active comparator | Participants will receive one session of conventional dry needling, followed by a structured exercise programme (3 sessions/week for 4 weeks). Receives: Other: Conventional Dry Needling + Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Immediately, 24, 48, and 72 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study startDec 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute, Instituto de Investigación Sanitaria Aragón
- Responsible party
- Principal investigator, Alberto Carcasona Otal, Universidad de Zaragoza
- Investigators
- Pablo Herrero, Study director, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527339
- Sponsor's protocol ID
- DN+V vs DN
- Acronym
- DryNeed+Vib
- Status last verified
- Sep 2026
- First submitted
- 4 Jul 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06527339
- Acronym / sponsor ID
- DryNeed+Vib / DN+V vs DN
- Keywords
- Non-specific low back pain, vibration dry needling, miofascial trigger points, dry needling, trigger point, mechanical vibration, non-inferiority trial, randomized trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Collaborators
- Carlos III Health Institute, Instituto de Investigación Sanitaria Aragón
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling with vibration + Exercise | Experimental | Other: Dry Needling with Vibration + ExerciseParticipants 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). |
| Conventional dry needling + Exercise | Active comparator | Other: Conventional Dry Needling + ExerciseParticipants will receive one session of conventional dry needling, followed by a structured exercise programme (3 sessions/week for 4 weeks). |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry Needling with Vibration + ExerciseParticipants 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. | Other | Dry needling with vibration + Exercise |
| Conventional Dry Needling + ExerciseParticipants 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. | Other | Conventional dry needling + Exercise |
Primary outcome
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, 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.
3 secondary outcomes
Acceptability
Time frame: 72 hours post-treatment
Pain During the Intervention
Time frame: Immediately post-treatment
Post-Needling Soreness
Time frame: Immediately, 24, 48, and 72 hours post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pablo Herrero study director
Universidad de Zaragoza
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling with Vibration + Exercise and Conventional Dry Needling + Exercise in people with Low Back Pain and Dry Needling, run by Universidad de Zaragoza at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberto Carcasona (+34666387648, acarcasona@unizar.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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, 72 hours, 1 week, and 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.