An interventional study of Percutaneous neuromodulation. and Therapeutic Exercise. in Neck Pain and Chronic Pain, sponsored by Universidad de Almeria. Completed at 1 site in Spain. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Universidad de Almeria · Not applicable, Interventional, and Treatment
The aim of this study is to compare the effects of applying percutaneous neuromodulation with performing only therapeutic exercise in patients with non-specific chronic neck pain.
Neck pain is highly prevalent, affecting 203 million people worldwide in 2020 and ranking eleventh in terms of years lived with disability. More than 50% of individuals will not recover from an acute episode and will experience recurrent neck pain within 1 to 5 years, leading to a persistent and chronic problem. Chronic neck pain can originate from a traumatic episode, such as whiplash, or it may not have a traumatic origin. In the latter case, in the absence of an identifiable pathoanatomic cause, it is classified as nonspecific chronic neck pain (NSNP). The GBD 2021 study acknowledges that the burden of neck pain has not been reduced in the past three decades and projects a significant increase in this absolute burden by 2050. Several studies have highlighted the urgency of prioritizing future research on preventing and treating this condition.
Clinical practice guidelines for the management of NSNP advocate for the use of exercise. Specifically, it has been shown that specific neck exercises are more effective than other types of alternative exercises in reducing pain and disability in patients with NSNP. In recent years, treatment based on percutaneous neuromodulation (PNM) has gained popularity and has become an alternative to conventional treatment for soft tissue injuries, noted for its low incidence of significant side effects. PNM involves the percutaneous electrical stimulation of a peripheral nerve, either along its pathway or in a muscle, using a puncture needle that utilizes low or medium-frequency electrical currents. Additionally, the advent of ultrasound technology has provided new opportunities to improve the safety of this invasive approach.
The primary goal of PNM is to relieve pain and restore the normal functioning of the nervous system, reducing chronic and neuropathic pain associated with central sensitization and improving neuromuscular function and motor control. Although the physiological mechanism explaining pain inhibition and the analgesic effect remains incomplete, various hypotheses have been proposed to expand current knowledge. Among the most cited models is the "gate control" theory, which suggests that the electrical stimulation of large-diameter afferent nerve fibers inhibits pain transmission through small-diameter fibers to the central nervous system at the spinal cord level, producing what is known as neuromodulation. However, few studies investigate the effects of PNM, so more evidence is needed to draw solid conclusions.
1,233 studies on the registry are indexed under Neck Pain; 256 are open to participants now.
This study's enrollment of 100 is above the median of 51 across 1,005 interventional studies indexed under Neck Pain.
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Exclusion Criteria:
Patients assigned to this group (n=50) will receive one weekly sessions of percutaneous neuromodulation for a total of 6 weeks, with each session lasting 30 minutes. For the treatment application, the patient will be positioned in a prone decubitus position, leaving the dorsal-cervical area exposed, and we will apply skin disinfectant (chlorhexidine). Subsequently, and under ultrasound guidance, we will perform the technique using a 30 x 40 mm acupuncture needle, which will be inserted at three vertebral levels and bilaterally: the greater occipital nerve (C0-C1), and the posterior roots of vertebral levels C3-C4 and C7-T1, the spinal nerve, suprascapular nerve and dorsal. Once the needles are correctly positioned, we will connect alligator clip electrodes segmentally, connecting them to an electrotherapy device (TensMed S82-Enraf Nonius) applying a TENS current. The parameters used will be set to low-frequency (2 Hz) symmetric biphasic pulsed current with a pulse width of 120 μs
Other: Percutaneous neuromodulation.
These participants (n=50) will engage in resistance training for the cervical flexor muscles, following a progressive exercise program in a supine position with the head comfortably supported, as described by Falla et al. (2008). Participants will perform these exercises with a frequency of 3 days a week for 6 weeks, with each session lasting 30 minutes.
Other: Therapeutic Exercise.
Percutaneous neuromodulation therapy involves inserting several fine needle electrodes 2 cm to 5 cm deep into the skin to target the muscle and surrounding soft tissues. A low-voltage electric current is then passed through these needles, which is hypothesized to improve muscle function by altering the pain signals traveling from the painful muscle to the brain, enhance blood flow to the painful area to promote healing, reduce inflammation and soreness, and increase muscle endurance, strength, and balance.
Also known as: Experimental
These participants (n=50) will engage in resistance training for the cervical flexor muscles, following a progressive exercise program in a supine position with the head comfortably supported, as described by Falla et al. (2008). Participants will perform these exercises with a frequency of 3 days a week for 6 weeks, with each session lasting 30 minutes.
Also known as: Active Comparator
Neck disability index
The neck disability index consists of 10 questions addressing functional activities such as personal care, lifting, reading, work, driving, sleeping, recreational, pain intensity, concentration and headache.
Time frame: At baseline, at 6 weeks and at 8 weekss.
Pain (Visual Analog Scale)
Pain will be assessed with the Visual Analog Scale (VAS), which assesses the pain intensity and degree of relief experienced by the patient (scored of 0 = no pain; 10 = unbearable pain).
Time frame: At baseline, at 6 weeks and at 8 weeks.
Pain (Visual Analog Scale)
Pain will be assessed with the Visual Analog Scale (VAS), which assesses the pain intensity and degree of relief experienced by the patient (scored of 0 = no pain; 10 = unbearable pain).
Time frame: At baseline, at 6 weeks and at 8 weeks.
McGill Pain Questionnaire
The McGill Pain Questionnaire is a self-reporting measure of pain used for patients with a number of diagnoses. It assesses both quality and intensity of subjective pain. The MPQ is a multi-dimesional tool for pain assessment and it has three components, which are the sensory intensity, the cognitive evaluation of pain and the emotional impact of pain.
Time frame: At baseline, at 6 weeks and at 8 weeks.
Quality of Life (SF-36 quality of life questionnaire)
The SF-36 quality of life questionnaire assesses 8 domains including physical functioning, physical role, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.
Time frame: At baseline, at 6 weeks and at 8 weeks.
Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)
The Pittsburgh Quality of Sleep Questionnaire Index (PSQI) will be used to study the quality of sleep. It comprises 24 items where the subjects respond to 19 of these items, and individual living in the same dwelling (or hospital room) responds to the remaining 5. Scores are obtained on each of 7 components of sleep quality: subjective quality, sleep latency, sleep duration, habitual sleep efficacy, sleep perturbations, use of hypnotic medication, and daily dysfunction.
Time frame: At baseline, at 6 weeks and at 8 weeks.
Tampa scale for kinesiophobia
The 17-item Tampa scale for kinesiophobia assesses fear of movement or of injury or reinjury.
Time frame: At baseline, at 6 weeks and at 8 weeks.
Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) is a self-assessment questionnaire to examine catastrophizing in clinical and nonclinical populations. Catastrophizing is commonly described as an exaggerated negative orientation toward noxious stimuli and plays an important role in experiencing and coping with pain. The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale.
Time frame: At baseline, at 6 weeks and at 8 weeks.
Treatment expectations
Questionnaire on treatment expectations and the patient's perception level
Time frame: At baseline, at 6 weeks and at 8 weeks.
Expectations regarding cervical pain
Questionnaire on expectations regarding cervical pain.
Time frame: At baseline, at 6 weeks and at 8 weeks.
Cervical Range of Motion (Pro Motion Capture. Werium)
Cervical range of motion is assessed with the patient sitting comfortably on a chair, with both feet flat on the floor, hips and knees at 90º of flexion, and buttocks positioned against the back of the chair.
Time frame: At baseline, at 6 weeks and at 8 weeks.
Active and Latent Myofascial Trigger Points (Number of trigger Points)
Myofascial Trigger Points will be explored in the following pairs of muscles: occipitofrontalis, splenius capitis, sternocleidomastoid, anterior scalene, middle scalene, posterior scalene, upper trapezius, middle trapezius, lower trapezius, supraspinatus, infraspinatus, and multifidus level C6.
Time frame: At baseline, at 6 weeks and at 8 weeks.
Plan to share: Yes — The study data will be available by email at ilp813@ual, provided that a reasonable request is made with justification for its scientific use and that citation is guaranteed.
Supporting information: Study protocol
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Universidad de Almeria