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

NCT ID: NCT07015281

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2026-02-15

Brief Summary

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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.

Detailed Description

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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

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Neck Pain

Keywords

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exercise quality of life electrical stimulation pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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

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.

Group Type EXPERIMENTAL

Therapeutic Exercise

Intervention Type OTHER

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.

Therapeutic Exercise

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

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.

Interventions

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

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.

Intervention Type OTHER

Therapeutic Exercise

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.

Intervention Type OTHER

Other Intervention Names

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Experimental Active Comparator

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Almeria

OTHER

Sponsor Role lead

Responsible Party

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Adelaida María Castro-Sánchez

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Adelaida María Castro Sánchez

Almería, Almeria, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 33740346 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32594264 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39140690 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37905789 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27410163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37546088 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37090321 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32990529 (View on PubMed)

Other Identifiers

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AP-0429-2023-C4-F3

Identifier Type: -

Identifier Source: org_study_id