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.
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.
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;
Parallel
Dry Needling with Vibration + Exercise
Other interventionParticipants 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
Other interventionParticipants 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.
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.
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.
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.
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.
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.
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.
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).
Click on the lead sponsor to view all of their trials.
Universidad de Zaragoza
Lead sponsor
Carlos III Health Institute
Collaborator
Instituto de Investigación Sanitaria Aragón
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
