Percutaneous Neuromodulation and Therapeutic Exercise in Patients With Chronic Neck Pain

NCT06695949 | Completed

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

Brief 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.

Conditions

Neck Pain; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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.

  At baseline, at 6 weeks and at 8 weekss.

• 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).

  At baseline, at 6 weeks and at 8 weeks.

Secondary Outcomes (10)

• Pain (Visual Analog Scale)

  At baseline, at 6 weeks and at 8 weeks.

• McGill Pain Questionnaire

  At baseline, at 6 weeks and at 8 weeks.

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

  At baseline, at 6 weeks and at 8 weeks.

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

  At baseline, at 6 weeks and at 8 weeks.

• Tampa scale for kinesiophobia

  At baseline, at 6 weeks and at 8 weeks.

Study Arms (2)

Percutaneous neuromodulation

EXPERIMENTAL

Patients 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

Other: Percutaneous neuromodulation.

Therapeutic Exercise

OTHER

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.

Other: Therapeutic Exercise.

Interventions

Therapeutic Exercise. OTHER

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.

Also known as: Active Comparator

Therapeutic Exercise

Percutaneous neuromodulation. OTHER

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.

Also known as: Experimental

Percutaneous neuromodulation

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

University of Almeria

Almería, 04120, Spain

Location

Related Publications (18)

• 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.

  PMID: 34980079 BACKGROUND

• 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.

  PMID: 38383088 BACKGROUND

• 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.

  PMID: 33069326 BACKGROUND

• 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.

  PMID: 33234017 BACKGROUND

• 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.

  PMID: 30614121 BACKGROUND

• 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.

  PMID: 33275908 BACKGROUND

• 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.

  PMID: 33358545 BACKGROUND

• 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.

  PMID: 28666405 BACKGROUND

• 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.

  PMID: 33064878 BACKGROUND

• 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.

  PMID: 30764789 BACKGROUND

• 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.

  PMID: 19632880 BACKGROUND

• 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.

  PMID: 17720609 BACKGROUND

• 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.

  PMID: 34935963 BACKGROUND

• 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.

  PMID: 36254060 BACKGROUND

• 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.

  PMID: 34099238 BACKGROUND

• Rossi M, DeCarolis G, Liberatoscioli G, Iemma D, Nosella P, Nardi LF. A Novel Mini-invasive Approach to the Treatment of Neuropathic Pain: The PENS Study. Pain Physician. 2016 Jan;19(1):E121-8.

  PMID: 26752480 BACKGROUND

• Chakravarthy K, Nava A, Christo PJ, Williams K. Review of Recent Advances in Peripheral Nerve Stimulation (PNS). Curr Pain Headache Rep. 2016 Nov;20(11):60. doi: 10.1007/s11916-016-0590-8.

  PMID: 27671799 BACKGROUND

• Lara-Palomo IC, Romero-Del Rey R, Saavedra-Hernandez M, Garcia-Lopez H, Fernandez-Sanchez M, Cohen SP, Castro-Sanchez AM. Comparison of percutaneous neuromodulation and therapeutic exercise in patients with chronic non-specific neck pain: a study protocol for a randomised controlled trial. BMJ Open. 2025 Jun 12;15(6):e097193. doi: 10.1136/bmjopen-2024-097193.

  PMID: 40506078 DERIVED

MeSH Terms

Conditions

Neck Pain; Chronic Pain

Interventions

Transcutaneous Electric Nerve Stimulation; Exercise Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Adelaida María Castro-Sánchez, PhD

  Universidad de Almeria

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: May 28, 2025
• Primary Completion: July 31, 2025
• Study Completion: September 15, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

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 ilp813@ual.es, provided that its scientific use and citation of our protocol are guaranteed.

Locations

ES (1)