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

NCT07015281 | Active Not Recruiting

• 1 other identifier: AP-0429-2023-C4-F3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neck Pain

Keywords

exercise; quality of life; electrical stimulation; pain

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (10)

• Pain (Visual Analog Scale)

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

• Quality of Life (SF-36 quality of life questionnaire).

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

• Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index).

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

• Tampa scale for kinesiophobia.

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

• Pain Catastrophizing Scale.

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

Study Arms (2)

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

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.

Other: Therapeutic Exercise

Therapeutic Exercise

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.

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

Interventions

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

Also known as: Experimental

Therapeutic Exercise

Therapeutic Exercise 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.

Also known as: Active Comparator

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

Adelaida María Castro Sánchez

Almería, Almeria, 04120, Spain

Location

Related Publications (8)

• 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.

  PMID: 33740346 BACKGROUND

• 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.

  PMID: 32594264 BACKGROUND

• 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.

  PMID: 39140690 BACKGROUND

• 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.

  PMID: 37905789 BACKGROUND

• 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.

  PMID: 27410163 BACKGROUND

• 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.

  PMID: 37546088 BACKGROUND

• 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.

  PMID: 37090321 BACKGROUND

• 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.

  PMID: 32990529 BACKGROUND

MeSH Terms

Conditions

Neck Pain; Motor Activity; Pain

Interventions

Dry Needling; Transcutaneous Electric Nerve Stimulation; Exercise Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Electric Stimulation Therapy; Rehabilitation; Analgesia; Anesthesia and Analgesia; Aftercare; Continuity of Patient Care; Patient Care

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: June 30, 2025
• Primary Completion: December 30, 2025
• Study Completion: February 15, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning with the first article publication; ending 5 years following article publication.
• Access Criteria: Data will be accessed via the contact email adelaid@ual.es, provided that its scientific use and citation of our protocol are guaranteed.

Locations

ES (1)