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: DN+V vs DN
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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; Trigger Points; Vibration

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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)

  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)

  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)

  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 Outcomes (5)

• Functional Disability (Roland-Morris Disability Questionnaire)

  Evaluation times will be immediately before the intervention and 48 hours, 1 week, and 4 weeks after intervention.

• Maximal Isometric Strength (dynamometry)

  Measurements will be conducted immediately before the intervention, immediately after the intervention, and at 1 and 4 weeks after the intervention

• Surface Electromyography (EMG)

  This variable will be measured immediately before the intervention, immediately after the intervention, and at 1 and 4 weeks.

• Pressure Pain Threshold (PPT) (algometry)

  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)

  This variable will be measured immediately before the intervention, 48 hours after the intervention, and 1 and 4 weeks after intervention.

Other Outcomes (2)

• Local Twitch Response

  Data collection will occur during the intervention period.

• Other adverse effects

  Adverse events will be recorded whenever reported by the participant.

Study Arms (2)

Dry needling with vibration + exercises

EXPERIMENTAL

Participants will receive dry needling combined with vibratory stimulation + exercises

Other: Dry Needling with Vibration + exercises

Conventional dry needling + exercises

ACTIVE COMPARATOR

Participants will receive conventional dry needling + exercises

Other: Conventional Dry Needling + exercises

Interventions

Dry Needling with Vibration + exercises OTHER

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.

Dry needling with vibration + exercises

Conventional Dry Needling + exercises OTHER

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.

Conventional dry needling + exercises

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (2)

Universidad de Zaragoza

Zaragoza, Zaragoza, 50009, Spain

Location

Centro de Salud Seminario

Zaragoza, Zaragoza, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Dry Needling; Vibration; Exercise

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; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological 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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To ensure allocation concealment, the assignments will be placed in sealed, opaque, and sequentially numbered envelopes. An assistant physiotherapist, not involved in assessment, will open the envelope corresponding to the participant's sequence number just before the intervention begins. To avoid evaluation bias, all outcome measurements (at baseline and all follow-up points) will be conducted by a physiotherapist who will be blinded to the participant's group allocation. Given the nature of the interventions, neither the treating physiotherapist nor the participant can be blinded; therefore, blinding the outcome assessor is the critical step to mitigate bias.
• 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 60 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 60 seconds at the maximum tolerable intensity, up to a maximum output of 5 volts.

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 30, 2024
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

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 (2)