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Effect of Dry Needling Plus Vibration on Myofascial Trigger Points in Individuals With Nonspecific Low Back Pain
Sponsor: Universidad de Zaragoza
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. 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.
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
Key Details
Gender
All
Age Range
35 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
108
Start Date
2026-12
Completion Date
2027-07
Last Updated
2026-10-05
Healthy Volunteers
No
Interventions
Dry Needling with Vibration + 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.
Conventional Dry Needling + Exercise
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.
Locations (2)
Universidad de Zaragoza
Zaragoza, Zaragoza, Spain
Centro de Salud Seminario
Zaragoza, Zaragoza, Spain