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Neck PainNCT06153875

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

A study testing Sensory Thresold, Burst High Frecuency, Theta-Burst Stimulation and Transcutaneous Electrical Nerve Stimulation in people with Neck Pain and Low Back Pain, run by Clinica Francisco Ortega Rehabilitacion Avanzada SL at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neck Pain, Low Back Pain
What is being tested?
Sensory Thresold, Burst High Frecuency, Theta-Burst Stimulation and Transcutaneous Electrical Nerve Stimulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteSpain
Study dates
22 Dec 2023to 5 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Ionclinics & DEIONICS

    Valencia

Other trials in Spain

About this study

Official title: Effects of Percutaneous Peripheral Nerve Stimulation on Neck and Low Back Pain: a Quadruple-blinded, Randomized Clinical Trial

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.

Read the 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.

Being tested
Sensory Thresold, Burst High Frecuency, Theta-Burst Stimulation, Transcutaneous Electrical Nerve Stimulation
Keywords
Percutaneous peripheral nerve stimulation, Sensorimotor effects, Neck pain, Transcutaneous electrical nerve stimulation, Theta burst stimulation, Low back pain
Medical subject headings
Neck Pain, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sensory Thresold, Burst High FrecuencyOther

    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.

  • Theta-Burst StimulationOther

    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.

  • Transcutaneous Electrical Nerve StimulationOther

    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.

Study groups in NCT06153875
Study groupRoleWhat they receive
Sensory Threshold, Burst High FrequencyExperimentalThe technique consists of percutaneous peripheral electrical stimulation on the Spinal or Inferior Gluteal and Tibial Nerve through a ultrasound-guided needle.
Receives: Other: Sensory Thresold, Burst High Frecuency
Theta-Burst StimulationExperimentalThe technique consists of percutaneous peripheral electrical stimulation on the Spinal or Inferior Gluteal and Tibial Nerve through a ultrasound-guided needle.
Receives: Other: Theta-Burst Stimulation
Transcutaneous Electrical Nerve StimulationActive comparatorThe technique consists of transcutaneous electrical nerve stimulation on the trapezius or low back and internal calf muscles through surface electrodes.
Receives: Other: Transcutaneous Electrical Nerve Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Pre-intervention and immediately after the intervention

Secondary outcomes (7)

  1. Demographic questionnaire

    Patients will fill a demographic data questionnaire with descriptive variables such as age, sex, work, time with pain, concomitant pathologies, level of sporting activity, toxic habits and drugs.

    Measured: Pre-intervention

  2. Change in pain

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

    One week after the intervention, and after having received a conventional physiotherapy treatment, subjects will verbally report a mean of the last week pain intensity according to the Numeric rate scale (NRS).

    Measured: Pre-intervention and one week after the intervention

  3. Change in pain evoked with movement

    Participants will be asked to perform a motion that evokes pain related to their pathology. After performing the movement, the pain perception will be obtained from 0 to 10 according to the NRS scale: 0 will be any pain and 10 will be the maximal perception of pain.

    Measured: Pre-intervention and immediately after the intervention

  4. Change in maximum strength during muscle contraction with dynamometer

    The maximum strength achievable given the condition will be assessed by means of a dynamometry test. Neck pain subjects will stand up and perform a maximum voluntary trapezius contraction by raising the shoulder towards the ceiling. Low back pain subjets will be in prone position, resting the trunk on the bed, but no the lower limbs, that will be resting on the floor. They will perform a maximum voluntary unilateral hip extension with the homolateral leg extended and the other leg resting on the floor. In order to not influence the measurement, all subjects will receive the same instructions on how to perform the contraction: "fast and hard", and will be encouraged during the task. Three test will be performed, and a first familiarisation test will be discarded. The rest between measurements will be 1 minute.

    Measured: Pre-intervention and immediately after the intervention

  5. Change in surface electromyography signal during muscle contraction

    Electrical activity of trapezius muscle (descending fibres) or gluteus maximus muscle will be measured synchronously with strength. Electromyography measurement will be performed in order to collect the muscle excitation signal during the muscle contraction. For the trapezius, electrodes will be placed in the middle of an imaginary line joining prominences of the acromion and C7's spinous apophysis. For the gluteus maximus, the electrodes will be placed in the middle of an imaginary line joining prominences of the sacrum and trochanter.

    Measured: Pre-intervention and immediately after the intervention

  6. Surface electromyography signal during stimulation

    Electrical activity of trapezius muscle (descending fibres) or gluteus maximus and internal calf muscle will be measured synchronously with treatment application. Electromyography measurement will be performed in order to collect the muscle excitation signal during the electrical stimulation. For the trapezius, the electrodes will be placed in the middle of an imaginary line joining prominences of the acromion and C7's spinous apophysis. For the gluteus maximus, the electrodes will be placed in the middle of an imaginary line joining prominences of the sacrum and trochanter. For the inner calf, a plantar flexion will be requested to the subject to visualize the center of the muscle belly, where the electrodes will be placed.

    Measured: During intervention

  7. Treatment-evoked perceptions questionnaire

    After the stimulation, subjects will be asked about their perceptions related to sensations during stimulation (pleasant- displeasing- indifferent), contraction of the area during the treatment (increasingly- decreasingly- equal), and changes in the strength of the treated area (more- less- equal).

    Measured: Immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2023
  2. Study start22 Dec 2023
  3. Primary completion5 Feb 2024
  4. Study completion5 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
Randomised quadruple-blind clinical trial, with three intervention groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06153875
Sponsor's protocol ID
EPTE/2023-TBS
Status last verified
Apr 2024
First submitted
23 Nov 2023
Last updated
25 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

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

    PubMed 21422790

  • 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.

    PubMed 7919934

  • 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.

    PubMed 26612235

  • 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.

    PubMed 9755013

  • 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.

    PubMed 33064878

  • 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

  • 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.

    PubMed 10071003

  • 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.

    PubMed 32289677

  • 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.

    PubMed 21621130

  • 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.

    PubMed 19004552

  • 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.

    PubMed 34880118

  • 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.

    PubMed 27042787

  • 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.

    PubMed 29451889

  • 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.

    PubMed 35144946

  • 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.

    PubMed 34980079

Questions about this trial

What is this clinical trial studying?

A study testing Sensory Thresold, Burst High Frecuency, Theta-Burst Stimulation and Transcutaneous Electrical Nerve Stimulation in people with Neck Pain and Low Back Pain, run by Clinica Francisco Ortega Rehabilitacion Avanzada SL at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain (time frame: Pre-intervention and immediately after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06153875, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.

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