Clinical trial NCT06153875: Effects of Percutaneous Peripheral Nerve Stimulation on Neck and Low Back Pain
Official title: Effects of Percutaneous Peripheral Nerve Stimulation on Neck and Low Back Pain: a Quadruple-blinded, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Clinica Francisco Ortega Rehabilitacion Avanzada SL
Sponsor class: OTHER
Collaborators: name: Ionclinics & DEIONICS.
First posted: 2023-12-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Randomised quadruple-blind clinical trial, with three intervention groups
Primary purpose: TREATMENT

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.

Detailed description: Intervention will be performed on the Spinal Nerve (for neck pain subjects) and Inferior Gluteal Nerve and Tibial Nerve (for low back pain subjects), using ultrasonography to guide the needle insertion, without risk of affecting any adjacent structure. The theoretical basis of the technique is to produce analgesia by making controlled changes in the somatosensory system using synaptic plasticity, to ultimate affect the perception of pain through reduction of nociception afference. The protocols will be the following:

* Intervention Group 1: Sensory Threshold, high frequency in trains (ST-bHF). 5 trains of 5 seconds, separated by 55 seconds from each other, at a frequency of 100 hertz (Hz), making 5 minutes of total treatment. The intensity will be set at patient's sensory threshold, ensuring a non-painful perception.
* Intervention Group 2: Theta-Burst Stimulation (TBS). 40 trains separated 10 seconds apart, where each train contains 5 trains separated by 200ms, at a frequency of 5 hertz, resulting in 6 minutes and 45 seconds of total intervention. The intensity will be set at patient's motor threshold, ensuring a non-painful stimulation.
* Intervention Group 3: Transcutaneous electrical nerve stimulation (TENS), at a frequency of 80 hertz 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 not painful sensory but not painful.

The study will be a randomised quadruple-blind clinical trial. Two pPNS protocols (ST-bHF, TBS) and a third TENS protocol (TENS) will be compared. To study the effects of these protocols on pain, strength, functionality and electromyographic activity, three measurements will be performed: pre-intervention (Numerical Pain Scale (NRS), NRS for induced pain, Maximal strength + EMG), during the intervention (EMG) and immediately post-intervention (NRS, NRS for induced pain, Maximal strength + EMG). In addition, one week later, subjects will be asked for a pain NRS to assess the mid-term treatment effect.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Pain
timeFrame: Pre-intervention and immediately after the intervention
Secondary outcomes:
measure: Demographic questionnaire
timeFrame: Pre-intervention
measure: Change in pain
timeFrame: Pre-intervention and one week after the intervention
measure: Change in pain evoked with movement
timeFrame: Pre-intervention and immediately after the intervention
measure: Change in maximum strength during muscle contraction with dynamometer
timeFrame: Pre-intervention and immediately after the intervention
measure: Change in surface electromyography signal during muscle contraction
timeFrame: Pre-intervention and immediately after the intervention
measure: Surface electromyography signal during stimulation
timeFrame: During intervention
measure: Treatment-evoked perceptions questionnaire
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Ionclinics & DEIONICS
Study officials:
affiliation: VIB-KULeuven
name: Enrique Velasco Serna, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abejon D, Perez-Cajaraville J. Peripheral nerve stimulation: definition. Prog Neurol Surg. 2011;24:203-209. doi: 10.1159/000323052. Epub 2011 Mar 21.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.