AzTrials
AzTrials

Neck PainNCT07015281

Dry Needling With Percutaneous Electrical Nerve Stimulation and Exercises for Non-specific Chronic Neck Pain

A study testing Dry Needling with Percutaneous Electrical Nerve Stimulation (PENS) and Therapeutic Exercises. and Therapeutic Exercise in people with Neck Pain, run by Universidad de Almeria at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The aim of this study is to compare the effects of applying dry needling with percutaneous electrical nerve stimulation + exercises verus therapeutic execises in patients with non-specific chronic neck pain. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Neck Pain
What is being tested?
Dry Needling with Percutaneous Electrical Nerve Stimulation (PENS) and Therapeutic Exercises. and Therapeutic Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSpain
Study dates
30 Jun 2025to 15 Feb 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Men and women aged between 30 and 65 years.
  • A diagnosis of non-specific neck pain,
  • Acceptance and signing of informed consent for voluntary participation in the research study.
  • Not currently receiving physiotherapy.

Who cannot join

  • Patients undergoing rehabilitative treatment for cervical pathologies.
  • Patients with osteosynthesis material at the cervical level and/or cardiac, epileptic, or tumour-related complications.
  • Patients who have undergone radiotherapy. in the last 6 months.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Adelaida María Castro Sánchez

    Almería, Almeria, 04120

Other trials in Spain

About this study

Official title: Dry Needling With Percutaneous Electrical Nerve Stimulation + Exercises Verus Therapeutic Execises in Patients With Non-specific Chronic Neck Pain

The aim of this study is to compare the effects of applying dry needling with percutaneous electrical nerve stimulation + exercises verus therapeutic execises in patients with non-specific chronic neck pain.

Read the detailed description

Globally, neck pain is considered the fourth leading cause of years lived with disability. It is estimated that up to 70% of the world's population will experience neck pain at least once in their lifetime, and between 50% and 85% of cases will become chronic within a five-year period.

The point prevalence of neck pain in the adult population, aged 15-74 years, ranges from 5.9% to 38.7%. This prevalence has been observed to peak in the 50-74 age group. In 2017, the global age-standardized prevalence and incidence of neck pain were 3551.1 and 806.6 per 100,000 population, respectively.

Dry needling with percutaneous electrical nerve stimulation has positive short-term effects on pain intensity, pain-related disability, and mood in patients with chronic nonspecific neck pain, compared with no or minimal intervention. However, the long-term impact could not be assessed due to a lack of available studies. Furthermore, strong evidence has been found suggesting that dry needling with percutaneous electrical nerve stimulation may improve mental well-being and mood in patients with chronic neck pain, especially in those with pain induced by high levels of stress.

Conditions
Neck Pain
Being tested
Dry Needling with Percutaneous Electrical Nerve Stimulation (PENS) and Therapeutic Exercises., Therapeutic Exercise
Keywords
exercise, quality of life, electrical stimulation, pain
Medical subject headings
Neck Pain, Motor Activity, Pain

What participants receive

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

  • Dry Needling with Percutaneous Electrical Nerve Stimulation (PENS) and Therapeutic Exercises.Other

    Also called Experimental

    Patients assigned to this group (n=50) will receive an intervention in which PENS will be applied for 30 minutes with low frequency parameters (2 Hz) and a pulse width of 120 μs. After 30 minutes of PENS in both groups, the needle will be removed and a compression will be applied for 90 seconds. Once the compression will carried out, the technique will be concluded. Patients will develop a session of PENS and a session with therapeutic exercise once a week.

  • Therapeutic ExerciseOther

    Also called Active Comparator

    These participants (n=50) will engage in an exercise protocol with aerobic, isometric, resistence, strength, and stretching exercises. Participants will perform these exercises with a frequency of 3 times a week for 6 weeks, with each session lasting 30 minutes.

Study groups in NCT07015281
Study groupRoleWhat they receive
Dry Needling with Percutaneous Electrical Nerve Stimulation (PENS) and Therapeutic Exercises.ExperimentalPatients assigned to this group (n=50) will receive an intervention in which PENS will be applied for 30 minutes with low frequency parameters (2 Hz) and a pulse width of 120 μs. After 30 minutes of PENS in both groups, the needle will be removed and a compression will be applied for 90 seconds. Once the compression will carried out, the technique will be concluded. Patients will develop a session of PENS and a session with therapeutic exercise once a week.
Receives: Other: Therapeutic Exercise
Therapeutic ExerciseActive comparatorThese participants (n=50) will engage in an exercise protocol with aerobic, isometric, resistence, strength, and stretching exercises. Participants will perform these exercises with a frequency of 3 times a week for 6 weeks, with each session lasting 30 minutes.
Receives: Other: Dry Needling with Percutaneous Electrical Nerve Stimulation (PENS) and Therapeutic Exercises.

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. Each item will be scored on a scale from 0 (no limitation). (severe limitation or inability to perform the activity). The total score will be calculated by summing the item scores, dividing by the maximum possible score of 50 (if all 10 questions are answered), and multiplying by 100 to generate a percentage. A score of 0% indicates full independence, while 100% represents complete dependence.

    Measured: At baseline, 6 weeks and 3 months (follow up).

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, 6 weeks and 3 months (follow up).

  2. 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. Scores range from 0 to 100% (with higher scores indicating greater health), reflecting the individual's self-perceived health-related quality of life.

    Measured: At baseline, 6 weeks and 3 months (follow up).

  3. 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. Using a four-point, Likert-type scale, respondents indicate how frequently they exhibit certain sleep behaviors (0 = "few," 1 = "sometimes," 2 = "often," and 3 = "almost always"). Scores on items belong to factors 2 and 5 (restoration after sleep and satisfaction with sleep) and are reversed before being tallied. Total scores can range from 0 to 84, with higher scores demoting more acute sleep problems.

    Measured: At baseline, 6 weeks and 3 months (follow up).

  4. Tampa scale for kinesiophobia.

    The 17-item Tampa scale for kinesiophobia assesses fear of movement or of injury or reinjury. Participants rate their beliefs regarding kinesiophobia on a 4-point Likert scale, ranging from "strongly disagree" to "strongly agree".

    Measured: At baseline, 6 weeks and 3 months (follow up).

  5. 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. The PCS consists of 13 statements containing several thoughts and feelings one may experience when having pain (scores 0-52).

    Measured: At baseline, 6 weeks and 3 months (follow up).

  6. 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, 6 weeks and 3 months (follow up).

  7. Spinal Isometric Strength (SIS).

    The investigators will measure the maximum isometric strength of the neck extensor muscles using a hand-held dynamometer (HHD). The patient will remain seated in a chair, with their feet flat on the floor, their hips and knees at 90º of flexion and the neck in the anatomical position, the patient will hold the HHD with both hands resting on their occiput, opposing the extension, and will be asked to perform a progressive isometric cervical extension for 3 seconds until reaching their maximum level of strength.

    Measured: At baseline, 6 weeks and 3 months (follow up).

  8. Neck Flexor Muscle Endurance Test (NFME).

    To measure the isometric endurance of the neck flexors, the investigators will place the patient in a supine position and ask him/her to perform a double chin tuck, which he/she must maintain throughout the test. While maintaining this position, he/she must flex his/her neck until his/her head is 2.5 cm off the table and maintain this position for as long as possible. The evaluator will time the duration of the test, which will be terminated if the patient loses the position for more than one second or asks to end due to fatigue or pain.

    Measured: At baseline, 6 weeks and 3 months (follow up).

  9. Treatment expectations.

    Questionnaire on treatment expectations and the patient's perception level.

    Measured: At baseline, 6 weeks and 3 months (follow up).

  10. Trigger points.

    Trigger oints will be measured in the following pairs of cervical muscles billaterally (right and left): occipitofrontalis, splenius capitis, sternocleidomastoid, anterior scalene, middele scalene, posterior scalene, upper trapezius, middle trapezius, lower trapezius, supraspinatus, infraspinatus, and multifidus level C6.

    Measured: At baseline, 6 weeks and 3 months (follow up).

Timeline

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

  1. First posted11 Jun 2025
  2. Study start30 Jun 2025
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion15 Feb 2026 (estimated)

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07015281
Sponsor's protocol ID
AP-0429-2023-C4-F3
Status last verified
Dec 2025
First submitted
3 Jun 2025
Last updated
22 Dec 2025
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 adelaid@ual.es, provided that a reasonable request is made with justification for its scientific use and that citation is guaranteed.

Publications

  • Hernandez JVL, Calvo-Lobo C, Zugasti AM, Fernandez-Carnero J, Beltran Alacreu H. Effectiveness of Dry Needling with Percutaneous Electrical Nerve Stimulation of High Frequency Versus Low Frequency in Patients with Myofascial Neck Pain. Pain Physician. 2021 Mar;24(2):135-143.

    PubMed 33740346
  • Galasso A, Urits I, An D, Nguyen D, Borchart M, Yazdi C, Manchikanti L, Kaye RJ, Kaye AD, Mancuso KF, Viswanath O. A Comprehensive Review of the Treatment and Management of Myofascial Pain Syndrome. Curr Pain Headache Rep. 2020 Jun 27;24(8):43. doi: 10.1007/s11916-020-00877-5.

    PubMed 32594264
  • Chen IW, Liao YT, Tseng H, Lin HC, Chou LW. Pain, function and peritendinous effusion improvement after dry needling in patients with long head of biceps brachii tendinopathy: a single-blind randomized clinical trial. Ann Med. 2024 Dec;56(1):2391528. doi: 10.1080/07853890.2024.2391528. Epub 2024 Aug 14.

    PubMed 39140690
  • Moro MZ, de Oliveira Vidal EI, Pinheiro Modolo NS, Bono Fukushima F, Moreira de Barros GA. Dry needling, trigger point electroacupuncture and motor point electroacupuncture for the treatment of myofascial pain syndrome involving the trapezius: a randomised clinical trial. Acupunct Med. 2024 Feb;42(1):3-13. doi: 10.1177/09645284231207865. Epub 2023 Oct 31.

    PubMed 37905789
  • Leon-Hernandez JV, Martin-Pintado-Zugasti A, Frutos LG, Alguacil-Diego IM, de la Llave-Rincon AI, Fernandez-Carnero J. Immediate and short-term effects of the combination of dry needling and percutaneous TENS on post-needling soreness in patients with chronic myofascial neck pain. Braz J Phys Ther. 2016 Jul 11;20(5):422-431. doi: 10.1590/bjpt-rbf.2014.0176.

    PubMed 27410163
  • Baumann AN, Fiorentino A, Oleson CJ, Leland JM 3rd. The Impact of Dry Needling With Electrical Stimulation on Pain and Disability in Patients With Musculoskeletal Shoulder Pain: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Cureus. 2023 Jul 5;15(7):e41404. doi: 10.7759/cureus.41404. eCollection 2023 Jul.

    PubMed 37546088
  • G A, Gupta AK, Kumar D, Mishra S, Yadav G, Singha Roy M, Prajapti L. Efficacy of Dry Needling Versus Transcutaneous Electrical Nerve Stimulation in Patients With Neck Pain Due to Myofascial Trigger Points: A Randomized Controlled Trial. Cureus. 2023 Mar 21;15(3):e36473. doi: 10.7759/cureus.36473. eCollection 2023 Mar.

    PubMed 37090321
  • Brennan K, Elifritz KM, Comire MM, Jupiter DC. Rate and maintenance of improvement of myofascial pain with dry needling alone vs. dry needling with intramuscular electrical stimulation: a randomized controlled trial. J Man Manip Ther. 2021 Aug;29(4):216-226. doi: 10.1080/10669817.2020.1824469. Epub 2020 Sep 29.

    PubMed 32990529

Questions about this trial

What is this clinical trial studying?

A study testing Dry Needling with Percutaneous Electrical Nerve Stimulation (PENS) and Therapeutic Exercises. and Therapeutic Exercise in people with Neck 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 22 Dec 2025. 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?

This study is still under way. Results are not available in the source record yet.

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, 6 weeks and 3 months (follow up).). 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 NCT07015281, which also lists 8 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 22 Dec 2025.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT07015281 | AzTrials