Clinical trial NCT07015281: Dry Needling With Percutaneous Electrical Nerve Stimulation and Exercises for Non-specific Chronic Neck Pain
Official title: Dry Needling With Percutaneous Electrical Nerve Stimulation + Exercises Verus Therapeutic Execises in Patients With Non-specific Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neck Pain
Keywords: exercise
quality of life
electrical stimulation
pain
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Neck Disability Index
timeFrame: At baseline, 6 weeks and 3 months (follow up).
Secondary outcomes:
measure: Pain (Visual Analog Scale)
timeFrame: At baseline, 6 weeks and 3 months (follow up).
measure: Quality of Life (SF-36 quality of life questionnaire).
timeFrame: At baseline, 6 weeks and 3 months (follow up).
measure: Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index).
timeFrame: At baseline, 6 weeks and 3 months (follow up).
measure: Tampa scale for kinesiophobia.
timeFrame: At baseline, 6 weeks and 3 months (follow up).
measure: Pain Catastrophizing Scale.
timeFrame: At baseline, 6 weeks and 3 months (follow up).
measure: Cervical Range of Motion (Pro Motion Capture. Werium).
timeFrame: At baseline, 6 weeks and 3 months (follow up).
measure: Spinal Isometric Strength (SIS).
timeFrame: At baseline, 6 weeks and 3 months (follow up).
measure: Neck Flexor Muscle Endurance Test (NFME).
timeFrame: At baseline, 6 weeks and 3 months (follow up).
measure: Treatment expectations.
timeFrame: At baseline, 6 weeks and 3 months (follow up).
measure: Trigger points.
timeFrame: At baseline, 6 weeks and 3 months (follow up).
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.