Percutaneous Neuromodulation and Therapeutic Exercise in Patients With Chronic Neck Pain

January 16, 2026 updated by: Adelaida María Castro-Sánchez, Universidad de Almeria

Comparison of Percutaneous Neuromodulation and Therapeutic Exercise in Patients With Nonspecific Chronic Neck Pain: A Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almería, Spain, 04120
        • University of Almeria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female patients aged between 30 and 65 years with chronic cervical pain.
  • 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, and 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.)
  • Contraindications for transcutaneous electrical nerve stimulation (TENS).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Therapeutic Exercise
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.
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 Names:
  • Active Comparator
Experimental: Percutaneous neuromodulation
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.
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.
Other Names:
  • Experimental

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck disability index
Time Frame: At baseline, at 6 weeks and at 8 weekss.
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.
At baseline, at 6 weeks and at 8 weekss.
Pain (Visual Analog Scale)
Time Frame: At baseline, at 6 weeks and at 8 weeks.
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).
At baseline, at 6 weeks and at 8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain (Visual Analog Scale)
Time Frame: At baseline, at 6 weeks and at 8 weeks.
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).
At baseline, at 6 weeks and at 8 weeks.
McGill Pain Questionnaire
Time Frame: At baseline, at 6 weeks and at 8 weeks.
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.
At baseline, at 6 weeks and at 8 weeks.
Quality of Life (SF-36 quality of life questionnaire)
Time Frame: At baseline, at 6 weeks and at 8 weeks.
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.
At baseline, at 6 weeks and at 8 weeks.
Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)
Time Frame: At baseline, at 6 weeks and at 8 weeks.
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.
At baseline, at 6 weeks and at 8 weeks.
Tampa scale for kinesiophobia
Time Frame: At baseline, at 6 weeks and at 8 weeks.
The 17-item Tampa scale for kinesiophobia assesses fear of movement or of injury or reinjury.
At baseline, at 6 weeks and at 8 weeks.
Pain Catastrophizing Scale
Time Frame: At baseline, at 6 weeks and at 8 weeks.
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.
At baseline, at 6 weeks and at 8 weeks.
Treatment expectations
Time Frame: At baseline, at 6 weeks and at 8 weeks.
Questionnaire on treatment expectations and the patient's perception level
At baseline, at 6 weeks and at 8 weeks.
Expectations regarding cervical pain
Time Frame: At baseline, at 6 weeks and at 8 weeks.
Questionnaire on expectations regarding cervical pain.
At baseline, at 6 weeks and at 8 weeks.
Cervical Range of Motion (Pro Motion Capture. Werium)
Time Frame: At baseline, at 6 weeks and at 8 weeks.
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.
At baseline, at 6 weeks and at 8 weeks.
Active and Latent Myofascial Trigger Points (Number of trigger Points)
Time Frame: At baseline, at 6 weeks and at 8 weeks.
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.
At baseline, at 6 weeks and at 8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Investigators

  • Principal Investigator: Adelaida María Castro-Sánchez, PhD, Universidad de Almeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2025

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

September 15, 2025

Study Registration Dates

First Submitted

November 15, 2024

First Submitted That Met QC Criteria

November 15, 2024

First Posted (Actual)

November 19, 2024

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP-0429-2023-C4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be available beginning with the first article publication; ending 5 years following article publication.

IPD Sharing Access Criteria

Data will be accessed via the contact email ilp813@ual.es, provided that its scientific use and citation of our protocol are guaranteed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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