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NCT Number: NCT06522893

Electrical Dry Needling and Therapeutic Exercise Versus Therapeutic Exercise in Patients With Nonspecific Chronic Neck Pain

To compare the effectiveness of electrical dry needling combined with therapeutic exercise versus therapeutic exercise alone in patients with nonspecific chronic mechanical neck pain.

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Key information

Conditions

Neck Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adelaida María Castro Sánchez

Almería, Almeria, 04120, Spain

About this study

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 electrical Dry Needling (DN) has gained popularity and has become an alternative to conventional treatment for soft tissue injuries, noted for its low incidence of significant side effects. This technique seeks to induce a local mechanical and microtraumatic response, optimizing the release of endogenous opioids, decreasing cortisol, improving microcirculation, and reducing proinflammatory mediators. All of this can contribute to improved motor control and pain relief. Additionally, the advent of ultrasound technology has provided new opportunities to improve the safety of this invasive approach.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patients aged between 30 and 65 years with chronic cervical pain lasting 3 months or more and not receiving any other type of physiotherapy treatment.

Exclusion criteria

  • Patients with sensory and/or coagulation disorders, history of spine surgery, cardiac complications, severe concurrent central or peripheral nervous system disease, epilepsy, needle phobia, disc pathology, or serious pathologies that may be the primary cause of chronic cervical pain (e.g., tumors, Arnold Chiari disease, vertigo syndrome, etc.) will be excluded, as they are contraindicated for transcutaneous electrical nerve stimulation (TENS).

Treatment and study plan

Electrical Dry Needling and Therapeutic exercise

Other

The group receiving dry needling combined with therapeutic exercise (n=35) will receive up to 6 sessions of stimulation at the active trigger points in the cervical region, according to Travell and Simons: occipitofrontalis, sternocleidomastoid, splenius capitis, anterior, middle, and posterior scalene muscles, upper, middle, and lower trapezius, and multifidus at the C6 level, bilaterally, once a week for 3 weeks. Using ultrasound guidance, 0.25 mm x 25 mm needles will be inserted into the active trigger points. The needles will be connected to a TENS (transcutaneous electrical nerve stimulation) device (TensMed S82-Enraf Nonius), applying an asymmetric biphasic square wave current, low frequency (2 Hz), pulse duration of 250 μs, for 30 minutes. In addition, this group will perform a protocol of specific therapeutic exercises for the cervical spine during the same electropuncture session and immediately afterward.

Therapeutic exercise

Other

The therapeutic exercise group (n=35) will perform progressive exercises for the cervical flexor and extensor muscles, once a week for 6 weeks (12 sessions in total). The protocol includes activation and recruitment of the deep cervical flexor muscles, isometric co-contraction exercises for both deep and superficial flexors, and eccentric and isokinetic exercises for both flexors and extensors. Each week's session will include the exercises for that week, along with the exercises from previous weeks, as detailed in the specific cervical spine exercise table, which indicates sets, repetitions, contraction time, and rest periods.

Primary outcomes

  1. Neck disability index

    Time frame: At baseline, at 6 weeks and at 2 months

    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.

Secondary outcomes

  1. Pain (Visual Analog Scale)

    Time frame: At baseline, at 6 weeks and at 2 months

    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).

  2. McGill Pain Questionnaire

    Time frame: At baseline, at 6 weeks and at 2 months

    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.

  3. Quality of Life (SF-36 quality of life questionnaire)

    Time frame: At baseline, at 6 weeks and at 2 months

    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.

  4. Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)

    Time frame: At baseline, at 6 weeks and at 2 months

    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.

  5. Tampa scale for kinesiophobia

    Time frame: At baseline, at 6 weeks and at 2 months

    The 17-item Tampa scale for kinesiophobia assesses fear of movement or of injury or reinjury.

  6. Pain Catastrophizing Scale

    Time frame: At baseline, at 6 weeks and at 2 months

    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.

  7. Treatment expectations

    Time frame: At baseline, at 6 weeks and at 2 months

    Questionnaire on treatment expectations and the patient's perception level

  8. Expectations regarding cervical pain

    Time frame: At baseline, at 6 weeks and at 2 months

    Questionnaire on expectations regarding cervical pain

  9. Cervical Range of Motion (Pro Motion Capture. Werium)

    Time frame: At baseline, at 6 weeks and at 2 months

    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.

  10. Active and Latent Myofascial Trigger Points (Number of trigger Points)

    Time frame: At baseline, at 6 weeks and at 2 months

    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.

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Official study title

Comparison of Electrical Dry Needling and Therapeutic Exercise Versus Therapeutic Exercise in Patients With Nonspecific Chronic Neck Pain: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 26, 2024
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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