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

NCT ID: NCT06522893

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-15
• Study Completion Date: 2026-03-15

Brief Summary

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

Detailed Description

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.

Conditions

Neck Pain; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Electrical Dry Needling and Therapeutic exercise

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. Using ultrasound guidance, 0.25 mm x 25 mm needles will be inserted into the active. 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 (8 Hz), pulse duration of 250 μs, with an intensity perceived as mild to moderate, for 30 minutes. In addition, this group will undergo a protocol of specific therapeutic exercises for the cervical spine during the same electropuncture session and immediately afterward.

Group Type: EXPERIMENTAL

Electrical Dry Needling and Therapeutic exercise

Intervention Type: 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

The therapeutic exercise group (n=35) will perform progressive exercises for the cervical flexor and extensor muscles, once a week for 6 weeks (6 sessions in total, with each session lasting 30 minutes). 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.

Group Type: ACTIVE_COMPARATOR

Therapeutic exercise

Intervention Type: 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.

Interventions

Electrical Dry Needling and Therapeutic exercise

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.

Intervention Type: OTHER

Therapeutic exercise

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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Almeria

OTHER

Sponsor Role: lead

Responsible Party

Adelaida María Castro-Sánchez

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Adelaida María Castro Sánchez

Almería, Almeria, Spain

Countries

Spain

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Other Identifiers

AP-0429-2023-C4-F2

Identifier Type: -

Identifier Source: org_study_id