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

NCT06527339 | Not Yet Recruiting DMC

• 1 other identifier: PI24/282(1)
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain; Dry Needling; Electrolysis; Trigger Points

Keywords

Non-specific low back pain; vibration dry needling; miofascial trigger points

Outcome Measures

Primary Outcomes (3)

• Nonspecific Low Back Pain (Numeric Pain Rating Scale)

  It refers to the nonspecific low back pain experienced by the study population. 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 before the intervention, immediately after the intervention, at 24 hours, and at 48 hours.

• Pain during treatment (Numeric Pain Rating Scale)

  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-puncture pain / post-treatment pain (Numeric Pain Rating Scale)

  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. The patient will be asked to record the intensity of the post-puncture pain at 12, 24, 36, 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.

  12, 24, 36, and 48 hours after the intervention

Other Outcomes (1)

• Local Twitch Response

  Data collection will occur during the intervention period.

Study Arms (2)

Dry needling with vibration for 10 minutes

EXPERIMENTAL

The patients will receive an intervention involving dry needling with vibration for 10 minutes.

Other: Dry Needling with Vibration

Conventional dry needling

ACTIVE COMPARATOR

The patients will receive an intervention involving conventional dry needling

Other: Conventional Dry Needling

Interventions

Dry Needling with Vibration OTHER

In the PS+V technique, no movements will be performed with the needle once it is correctly inserted. Instead, only vibratory stimulus will be applied for 10 minutes. Since this is a completely novel technique, the optimal duration of application is not yet known; however, it is considered that 10 minutes may be sufficient to demonstrate an effect.

Dry needling with vibration for 10 minutes

Conventional Dry Needling OTHER

In the conventional PS technique, the needle will be inserted into the MTrP using the "fast-in and fast-out" technique described by Hong (1994) at an approximate frequency of 1 insertion per second (1 Hz) without completely withdrawing the needle from the skin. This technique will be maintained for 30 seconds in an attempt to elicit a local twitch response. After the procedure, the treated area will be firmly compressed with a cotton pad for three seconds.

Conventional dry needling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with nonspecific low back pain, defined as pain persisting for more than 3 months between the twelfth rib and the buttocks, registering a Numeric Pain Rating Scale (NPRS) score of 3 or higher prior to the intervention. Additionally, participants must meet the following criteria:
• Presence of myofascial trigger points (PGMs) in any of the following muscles relevant to the project: erector spinae (longissimus and iliocostal), multifidus, gluteus maximus, gluteus medius, and quadratus lumborum. Detection of these PGMs will be conducted by a specialized physiotherapist.
• Individuals aged 18 years or older, proficient in either Spanish or English. Participants who have provided informed consent by signing the consent form

You may not qualify if:

• Diagnosis of lumbar pain associated with specific pathologies such as disc herniations or neurological disorders.
• Recent infiltration therapy within the past 3 months.
• Recent manual therapy, acupuncture, or dry needling interventions in the lumbopelvic region within the last 4 weeks.
• Previous surgical intervention in the lumbopelvic region.
• Leg length discrepancy (\>1 cm).
• Recent use of anticoagulant or antiplatelet medications within the last week.
• Systemic or local infection in the lumbar region.
• Pregnancy.
• Needle phobia (belonephobia).

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

Universidad de Zaragoza

Zaragoza, Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Dry Needling; Vibration

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Mechanical Phenomena; Physical Phenomena

Study Officials

• Pablo Herrero

  Universidad de Zaragoza

  STUDY DIRECTOR

Central Study Contacts

Alberto Carcasona

CONTACT

+34666387648; acarcasona@unizar.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Model Details: Two intervention groups will be generated for the study: * One group will receive conventional dry needling treatment. The needle will be inserted into the myofascial trigger point (MTrP) using the "quick in-and-out" technique described by Hong (1994), with an approximate frequency of 1 insertion per second (1 Hz), without fully withdrawing the needle from the skin. This technique will be maintained for 30 seconds, aiming to produce a local twitch response. At the conclusion of the technique, firm compression with cotton will be applied to the treated area for three seconds. * The other group will receive dry needling + vibration. In this case, no movements will be made with the needle after it is correctly inserted. Instead, vibratory stimulation will be applied to the needle for 10 minutes. Since this is a completely novel technique, the optimal application time is not yet established; however, 10 minutes is considered sufficient duration to observe an effect.

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 30, 2024
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Once research has been published
• Access Criteria: Study protocol will be publish in a scientific journal.

Locations

ES (1)