Effects of Percutaneous Peripheral Nerve Stimulation on Neck and Low Back Pain

NCT06153875 | Completed

• 1 other identifier: EPTE/2023-TBS
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Percutaneous Peripheral Nerve Stimulation (pPNS) is a physical therapy technique, whose main objective is to treat neuro-musculo-skeletal signs and symptoms by applying a current to a peripheric nerve with a blunt dry needle. Despite its clinical use being already stablished, its use in pathologic subjects is still unknown and, thus, so is its optimal parameterization. The present study proposes to perform two different protocols of peripheral nerve stimulation on neck and low back pain subjects to answer those questions and compared it towards a control group receiving a standard intervention.

Conditions

Neck Pain; Low Back Pain

Keywords

Percutaneous peripheral nerve stimulation; Sensorimotor effects; Neck pain; Transcutaneous electrical nerve stimulation; Theta burst stimulation; Low back pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain

  The subject will verbally report the pain intensity suffered along the last week according to the Numeric rate scale (NRS): 0 will be any pain and 10 will be the maximal perception of pain.

  Pre-intervention and immediately after the intervention

Secondary Outcomes (7)

• Demographic questionnaire

  Pre-intervention

• Change in pain

  Pre-intervention and one week after the intervention

• Change in pain evoked with movement

  Pre-intervention and immediately after the intervention

• Change in maximum strength during muscle contraction with dynamometer

  Pre-intervention and immediately after the intervention

• Change in surface electromyography signal during muscle contraction

  Pre-intervention and immediately after the intervention

Study Arms (3)

Sensory Threshold, Burst High Frequency

EXPERIMENTAL

The technique consists of percutaneous peripheral electrical stimulation on the Spinal or Inferior Gluteal and Tibial Nerve through a ultrasound-guided needle.

Other: Sensory Thresold, Burst High Frecuency

Theta-Burst Stimulation

EXPERIMENTAL

The technique consists of percutaneous peripheral electrical stimulation on the Spinal or Inferior Gluteal and Tibial Nerve through a ultrasound-guided needle.

Other: Theta-Burst Stimulation

Transcutaneous Electrical Nerve Stimulation

ACTIVE COMPARATOR

The technique consists of transcutaneous electrical nerve stimulation on the trapezius or low back and internal calf muscles through surface electrodes.

Other: Transcutaneous Electrical Nerve Stimulation

Interventions

Sensory Thresold, Burst High Frecuency OTHER

The ultrasound guided percutaneous peripheral nerve stimulation will be applied to the Spinal or Inferior Gluteal and Tibial Nerve. The parameters will be 5 trains of 5 seconds, 55 seconds apart, at a frequency of 100Hz, making 5 minutes of total treatment. The intensity will be set 200 microamperes (μA) above the detection threshold for each patient, guaranteeing a sensitive but not painful perception.

Sensory Threshold, Burst High Frequency

Theta-Burst Stimulation OTHER

The ultrasound guided percutaneous peripheral nerve stimulation will be applied to the Spinal or Inferior Gluteal and Tibial Nerve. The parameters will be 40 trains separated by 7 seconds from each other, where each train contains 5 trains separated by 200ms, at a frequency of 5Hz, resulting in 6 minutes and 45 seconds of total treatment. The intensity will be set at the motor threshold of the patient, ensuring a non-painful stimulation.

Theta-Burst Stimulation

Transcutaneous Electrical Nerve Stimulation OTHER

The transcutaneous electrical nerve stimulation will be applied on the trapezius or low back and internal calf muscles at a frequency of 80Hz and a pulse width of 250 microseconds, for 15 minutes. The intensity will be set at the detection threshold of each patient generating a sensitive but non-painful perception.

Transcutaneous Electrical Nerve Stimulation

Eligibility Criteria

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

You may qualify if:

• Adults (+18 years)
• Patients with non-specific/mechanical/articular neck pain.
• Patients with non-specific/mechanical/articular low back pain and/or low back pain accompanied by radicular symptomatology or sciatica.

You may not qualify if:

• Pregnancy.
• Severe illnesses: diabetes, cancer, neurological diseases, depression, etc...
• Balanophora (needle phobia).
• Professional athlete.
• Other concomitant physiotherapy treatment for this pathology.
• Patients with neck or low back pain associated with severe bone damage such as fractures or vertebral fissures.

Sponsors & Collaborators

• Clinica Francisco Ortega Rehabilitacion Avanzada SL: lead
• Ionclinics & DEIONICS.: collaborator

Study Sites (1)

Ionclinics & DEIONICS

Valencia, Spain

Location

Related Publications (34)

• Abejon D, Perez-Cajaraville J. Peripheral nerve stimulation: definition. Prog Neurol Surg. 2011;24:203-209. doi: 10.1159/000323052. Epub 2011 Mar 21.

  PMID: 21422790 BACKGROUND

• Bear MF, Malenka RC. Synaptic plasticity: LTP and LTD. Curr Opin Neurobiol. 1994 Jun;4(3):389-99. doi: 10.1016/0959-4388(94)90101-5.

  PMID: 7919934 BACKGROUND

• Bevan S. Economic impact of musculoskeletal disorders (MSDs) on work in Europe. Best Pract Res Clin Rheumatol. 2015 Jun;29(3):356-73. doi: 10.1016/j.berh.2015.08.002. Epub 2015 Oct 24.

  PMID: 26612235 BACKGROUND

• Borghouts JAJ, Koes BW, Bouter LM. The clinical course and prognostic factors of non-specific neck pain: a systematic review. Pain. 1998 Jul;77(1):1-13. doi: 10.1016/S0304-3959(98)00058-X.

  PMID: 9755013 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

• Delgado Conforme, W. A., Abarca López, J. J., Boada Rodríguez, L. E., & Salazar Trujillo, S. E. (2019). Lumbalgia inespecífica. Dolencia más común de lo que se cree. RECIMUNDO, 3(2), 3-25. https://doi.org/10.26820/recimundo/3.(2).abril.2019.3-25

  BACKGROUND

• Ghoname EA, Craig WF, White PF, Ahmed HE, Hamza MA, Henderson BN, Gajraj NM, Huber PJ, Gatchel RJ. Percutaneous electrical nerve stimulation for low back pain: a randomized crossover study. JAMA. 1999 Mar 3;281(9):818-23. doi: 10.1001/jama.281.9.818.

  PMID: 10071003 BACKGROUND

• Gutierrez-Muto AM, Castilla J, Freire M, Oliviero A, Tornero J. Theta burst stimulation: Technical aspects about TMS devices. Brain Stimul. 2020 May-Jun;13(3):562-564. doi: 10.1016/j.brs.2020.01.002. Epub 2020 Jan 9. No abstract available.

  PMID: 32289677 BACKGROUND

• Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.

  PMID: 21621130 BACKGROUND

• Hjornevik T, Jacobsen LM, Qu H, Bjaalie JG, Gjerstad J, Willoch F. Metabolic plasticity in the supraspinal pain modulating circuitry after noxious stimulus-induced spinal cord LTP. Pain. 2008 Dec;140(3):456-464. doi: 10.1016/j.pain.2008.09.029. Epub 2008 Nov 11.

  PMID: 19004552 BACKGROUND

• Huang Y, Chen SR, Chen H, Zhou JJ, Jin D, Pan HL. Theta-Burst Stimulation of Primary Afferents Drives Long-Term Potentiation in the Spinal Cord and Persistent Pain via alpha2delta-1-Bound NMDA Receptors. J Neurosci. 2022 Jan 19;42(3):513-527. doi: 10.1523/JNEUROSCI.1968-21.2021. Epub 2021 Dec 8.

  PMID: 34880118 BACKGROUND

• Jauregui JJ, Cherian JJ, Gwam CU, Chughtai M, Mistry JB, Elmallah RK, Harwin SF, Bhave A, Mont MA. A Meta-Analysis of Transcutaneous Electrical Nerve Stimulation for Chronic Low Back Pain. Surg Technol Int. 2016 Apr;28:296-302.

  PMID: 27042787 BACKGROUND

• Jimenez S, Mordillo-Mateos L, Dileone M, Campolo M, Carrasco-Lopez C, Moitinho-Ferreira F, Gallego-Izquierdo T, Siebner HR, Valls-Sole J, Aguilar J, Oliviero A. Effects of patterned peripheral nerve stimulation on soleus spinal motor neuron excitability. PLoS One. 2018 Feb 16;13(2):e0192471. doi: 10.1371/journal.pone.0192471. eCollection 2018.

  PMID: 29451889 BACKGROUND

• Johnson MI, Paley CA, Jones G, Mulvey MR, Wittkopf PG. Efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for acute and chronic pain in adults: a systematic review and meta-analysis of 381 studies (the meta-TENS study). BMJ Open. 2022 Feb 10;12(2):e051073. doi: 10.1136/bmjopen-2021-051073.

  PMID: 35144946 BACKGROUND

• 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

• Knezevic NN, Candido KD, Vlaeyen JWS, Van Zundert J, Cohen SP. Low back pain. Lancet. 2021 Jul 3;398(10294):78-92. doi: 10.1016/S0140-6736(21)00733-9. Epub 2021 Jun 8.

  PMID: 34115979 BACKGROUND

• Lall MP, Restrepo E. The Biopsychosocial Model of Low Back Pain and Patient-Centered Outcomes Following Lumbar Fusion. Orthop Nurs. 2017 May/Jun;36(3):213-221. doi: 10.1097/NOR.0000000000000350.

  PMID: 28538537 BACKGROUND

• Larson J, Munkacsy E. Theta-burst LTP. Brain Res. 2015 Sep 24;1621:38-50. doi: 10.1016/j.brainres.2014.10.034. Epub 2014 Oct 27.

  PMID: 25452022 BACKGROUND

• Larson J, Wong D, Lynch G. Patterned stimulation at the theta frequency is optimal for the induction of hippocampal long-term potentiation. Brain Res. 1986 Mar 19;368(2):347-50. doi: 10.1016/0006-8993(86)90579-2.

  PMID: 3697730 BACKGROUND

• Lin T, Gargya A, Singh H, Sivanesan E, Gulati A. Mechanism of Peripheral Nerve Stimulation in Chronic Pain. Pain Med. 2020 Aug 1;21(Suppl 1):S6-S12. doi: 10.1093/pm/pnaa164.

  PMID: 32804230 BACKGROUND

• Luo C, Kuner T, Kuner R. Synaptic plasticity in pathological pain. Trends Neurosci. 2014 Jun;37(6):343-55. doi: 10.1016/j.tins.2014.04.002. Epub 2014 May 12.

  PMID: 24833289 BACKGROUND

• Maffiuletti NA, Aagaard P, Blazevich AJ, Folland J, Tillin N, Duchateau J. Rate of force development: physiological and methodological considerations. Eur J Appl Physiol. 2016 Jun;116(6):1091-116. doi: 10.1007/s00421-016-3346-6. Epub 2016 Mar 3.

  PMID: 26941023 BACKGROUND

• Martimbianco ALC, Porfirio GJ, Pacheco RL, Torloni MR, Riera R. Transcutaneous electrical nerve stimulation (TENS) for chronic neck pain. Cochrane Database Syst Rev. 2019 Dec 12;12(12):CD011927. doi: 10.1002/14651858.CD011927.pub2.

  PMID: 31830313 BACKGROUND

• Plaza-Manzano G, Gomez-Chiguano GF, Cleland JA, Arias-Buria JL, Fernandez-de-Las-Penas C, Navarro-Santana MJ. Effectiveness of percutaneous electrical nerve stimulation for musculoskeletal pain: A systematic review and meta-analysis. Eur J Pain. 2020 Jul;24(6):1023-1044. doi: 10.1002/ejp.1559. Epub 2020 Apr 4.

  PMID: 32171035 BACKGROUND

• Popescu A, Lee H. Neck Pain and Lower Back Pain. Med Clin North Am. 2020 Mar;104(2):279-292. doi: 10.1016/j.mcna.2019.11.003. Epub 2019 Dec 20.

  PMID: 32035569 BACKGROUND

• Rampazo EP, Martignago CCS, de Noronha M, Liebano RE. Transcutaneous electrical stimulation in neck pain: A systematic review and meta-analysis. Eur J Pain. 2022 Jan;26(1):18-42. doi: 10.1002/ejp.1845. Epub 2021 Aug 3.

  PMID: 34288255 BACKGROUND

• Ranck JB Jr. Studies on single neurons in dorsal hippocampal formation and septum in unrestrained rats. I. Behavioral correlates and firing repertoires. Exp Neurol. 1973 Nov;41(2):461-531. doi: 10.1016/0014-4886(73)90290-2. No abstract available.

  PMID: 4355646 BACKGROUND

• Rudell AP, Fox SE, Ranck JB Jr. Hippocampal excitability phase-locked to the theta rhythm in walking rats. Exp Neurol. 1980 Apr;68(1):87-96. doi: 10.1016/0014-4886(80)90068-0. No abstract available.

  PMID: 7363990 BACKGROUND

• Svendsen F, Tjolsen A, Hole K. LTP of spinal A beta and C-fibre evoked responses after electrical sciatic nerve stimulation. Neuroreport. 1997 Nov 10;8(16):3427-30. doi: 10.1097/00001756-199711100-00002.

  PMID: 9427300 BACKGROUND

• Van Breukelen GJ. ANCOVA versus change from baseline: more power in randomized studies, more bias in nonrandomized studies [corrected]. J Clin Epidemiol. 2006 Sep;59(9):920-5. doi: 10.1016/j.jclinepi.2006.02.007. Epub 2006 Jun 23.

  PMID: 16895814 BACKGROUND

• Wall PD, Sweet WH. Temporary abolition of pain in man. Science. 1967 Jan 6;155(3758):108-9. doi: 10.1126/science.155.3758.108.

  PMID: 6015561 BACKGROUND

• Wu J, Hu Q, Huang D, Chen X, Chen J. Effect of electrical stimulation of sciatic nerve on synaptic plasticity of spinal dorsal horn and spinal c-fos expression in neonatal, juvenile and adult rats. Brain Res. 2012 Apr 11;1448:11-9. doi: 10.1016/j.brainres.2012.02.002. Epub 2012 Feb 13.

  PMID: 22377455 BACKGROUND

• Yang F, Guo J, Sun WL, Liu FY, Cai J, Xing GG, Wan Y. The induction of long-term potentiation in spinal dorsal horn after peripheral nociceptive stimulation and contribution of spinal TRPV1 in rats. Neuroscience. 2014 Jun 6;269:59-66. doi: 10.1016/j.neuroscience.2014.03.037. Epub 2014 Mar 26.

  PMID: 24680883 BACKGROUND

• Ortega FJ, Giner MJ, Perez-Cervera L, Tomas E, Valdesuso R, Navarro I, Delicado-Miralles M, Velasco E. Plasticity-Inducing Percutaneous Peripheral Nerve Stimulation for Treating Neck Pain: A Blinded, Randomised Clinical Trial. Eur J Pain. 2026 Jan;30(1):e70207. doi: 10.1002/ejp.70207.

  PMID: 41555668 DERIVED

MeSH Terms

Conditions

Neck Pain; Low Back Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Enrique Velasco Serna, PhD

  VIB-KULeuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The order of the interventions will be randomized by a third person not involved in the treatment, assessment or statistical analysis. Once the care provider has inserted the needle in each subject, another third person will choose the protocol assigned on the stimulator, previously programmed and codified. Another investigator will take measurements of the variables of interest. Thus, nobody (participant, care provider, investigator and the outcome assessor) will know what intervention is applied.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised quadruple-blind clinical trial, with three intervention groups

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 1, 2023
• Study Start: December 22, 2023
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

ES (1)