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Neck PainNCT06695949

Percutaneous Neuromodulation and Therapeutic Exercise in Patients With Chronic Neck Pain

A study testing Percutaneous neuromodulation. and Therapeutic Exercise. in people with Neck Pain and Chronic Pain, run by Universidad de Almeria at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
Neck Pain, Chronic Pain
What is being tested?
Percutaneous neuromodulation. and Therapeutic Exercise.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSpain
Study dates
28 May 2025to 15 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • University of Almeria

    Almería, 04120

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Percutaneous neuromodulation., Therapeutic Exercise.
Medical subject headings
Neck Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous neuromodulation.Other

    Also called Experimental

    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.

  • Therapeutic Exercise.Other

    Also called Active Comparator

    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.

Study groups in NCT06695949
Study groupRoleWhat they receive
Percutaneous neuromodulationExperimentalPatients 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
Receives: Other: Percutaneous neuromodulation.
Therapeutic ExerciseOtherThese 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.
Receives: Other: Therapeutic Exercise.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At baseline, at 6 weeks and at 8 weekss.

  2. 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).

    Measured: At baseline, at 6 weeks and at 8 weeks.

Secondary outcomes (10)
  1. 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).

    Measured: At baseline, at 6 weeks and at 8 weeks.

  2. 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.

    Measured: At baseline, at 6 weeks and at 8 weeks.

  3. 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.

    Measured: At baseline, at 6 weeks and at 8 weeks.

  4. 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.

    Measured: At baseline, at 6 weeks and at 8 weeks.

  5. Tampa scale for kinesiophobia

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

    Measured: At baseline, at 6 weeks and at 8 weeks.

  6. 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.

    Measured: At baseline, at 6 weeks and at 8 weeks.

  7. Treatment expectations

    Questionnaire on treatment expectations and the patient's perception level

    Measured: At baseline, at 6 weeks and at 8 weeks.

  8. Expectations regarding cervical pain

    Questionnaire on expectations regarding cervical pain.

    Measured: At baseline, at 6 weeks and at 8 weeks.

  9. 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.

    Measured: At baseline, at 6 weeks and at 8 weeks.

  10. 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.

    Measured: At baseline, at 6 weeks and at 8 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2024
  2. Study start28 May 2025
  3. Primary completion31 Jul 2025
  4. Study completion15 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06695949
Sponsor's protocol ID
AP-0429-2023-C4
Status last verified
Jan 2026
First submitted
15 Nov 2024
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Kazeminasab S, Nejadghaderi SA, Amiri P, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Neck pain: global epidemiology, trends and risk factors. BMC Musculoskelet Disord. 2022 Jan 3;23(1):26. doi: 10.1186/s12891-021-04957-4.

    PubMed 34980079
  • GBD 2021 Neck Pain Collaborators. Global, regional, and national burden of neck pain, 1990-2020, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol. 2024 Mar;6(3):e142-e155. doi: 10.1016/S2665-9913(23)00321-1.

    PubMed 38383088
  • GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.

    PubMed 33069326
  • Fandim JV, Nitzsche R, Michaleff ZA, Pena Costa LO, Saragiotto B. The contemporary management of neck pain in adults. Pain Manag. 2021 Jan;11(1):75-87. doi: 10.2217/pmt-2020-0046. Epub 2020 Nov 25.

    PubMed 33234017
  • Farrell SF, Smith AD, Hancock MJ, Webb AL, Sterling M. Cervical spine findings on MRI in people with neck pain compared with pain-free controls: A systematic review and meta-analysis. J Magn Reson Imaging. 2019 Jun;49(6):1638-1654. doi: 10.1002/jmri.26567. Epub 2019 Jan 5.

    PubMed 30614121
  • Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T. Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2021 Dec 19;396(10267):2006-2017. doi: 10.1016/S0140-6736(20)32340-0. Epub 2020 Dec 1.

    PubMed 33275908
  • Verhagen AP. Physiotherapy management of neck pain. J Physiother. 2021 Jan;67(1):5-11. doi: 10.1016/j.jphys.2020.12.005. Epub 2020 Dec 24. No abstract available.

    PubMed 33358545
  • Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.

    PubMed 28666405
  • Corp N, Mansell G, Stynes S, Wynne-Jones G, Morso L, Hill JC, van der Windt DA. Evidence-based treatment recommendations for neck and low back pain across Europe: A systematic review of guidelines. Eur J Pain. 2021 Feb;25(2):275-295. doi: 10.1002/ejp.1679. Epub 2020 Nov 12.

    PubMed 33064878
  • Parikh P, Santaguida P, Macdermid J, Gross A, Eshtiaghi A. Comparison of CPG's for the diagnosis, prognosis and management of non-specific neck pain: a systematic review. BMC Musculoskelet Disord. 2019 Feb 14;20(1):81. doi: 10.1186/s12891-019-2441-3.

    PubMed 30764789
  • Jull GA, Falla D, Vicenzino B, Hodges PW. The effect of therapeutic exercise on activation of the deep cervical flexor muscles in people with chronic neck pain. Man Ther. 2009 Dec;14(6):696-701. doi: 10.1016/j.math.2009.05.004. Epub 2009 Jul 25.

    PubMed 19632880
  • Falla D, Jull G, Hodges P. Training the cervical muscles with prescribed motor tasks does not change muscle activation during a functional activity. Man Ther. 2008 Dec;13(6):507-12. doi: 10.1016/j.math.2007.07.001. Epub 2007 Aug 27.

    PubMed 17720609
  • Villanueva-Ruiz I, Falla D, Lascurain-Aguirrebena I. Effectiveness of Specific Neck Exercise for Nonspecific Neck Pain; Usefulness of Strategies for Patient Selection and Tailored Exercise-A Systematic Review With Meta-Analysis. Phys Ther. 2022 Feb 1;102(2):pzab259. doi: 10.1093/ptj/pzab259.

    PubMed 34935963
  • Fidalgo-Martin I, Ramos-Alvarez JJ, Murias-Lozano R, Rodriguez-Lopez ES. Effects of percutaneous neuromodulation in neuromusculoskeletal pathologies: A systematic review. Medicine (Baltimore). 2022 Oct 14;101(41):e31016. doi: 10.1097/MD.0000000000031016.

    PubMed 36254060
  • Romero-Morales C, Bravo-Aguilar M, Abuin-Porras V, Almazan-Polo J, Calvo-Lobo C, Martinez-Jimenez EM, Lopez-Lopez D, Navarro-Flores E. Current advances and novel research on minimal invasive techniques for musculoskeletal disorders. Dis Mon. 2021 Oct;67(10):101210. doi: 10.1016/j.disamonth.2021.101210. Epub 2021 Jun 4.

    PubMed 34099238

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous neuromodulation. and Therapeutic Exercise. in people with Neck Pain and Chronic Pain, run by Universidad de Almeria at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neck disability index (time frame: At baseline, at 6 weeks and at 8 weekss.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06695949, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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