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Completed

NCT Number: NCT06480851

Effectiveness of Percutaneous Neuromodulation in the Treatment of Cervical Pain in University Students.

A non-randomized experimental study will be conducted to investigate the effect of Ecoguided Percutaneous Neuromodulation on patients with and without neck pain in college students. The sample will be collected in a non-probabilistic way at convenience among the students at the San Pablo-CEU University, with a sample that will be divided into two groups: group 1 (G1) with neck pain and group 2 (G2).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Pablo CEU University

Boadilla del Monte, Madrid, 28668, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current Cervical Pain on a Visual Analog Scale (VAS) greater than 3.
  • Neck pain in the last 12 weeks, and no treatment has been performed.
  • Disability index of 8% or more on the Neck Disability Index.
  • That they have undergone treatment.

Exclusion criteria

  • Neck pain associated with vertigo.
  • Osteoporosis (control X-ray).
  • Diagnosed psychological disorders.
  • Vertebral fractures (control X-ray).
  • Tumors.
  • Diagnosed metabolic diseases.
  • Neck surgery.
  • Belonephobia.

Treatment and study plan

Ecoguided Percutaneous Neuromodulation

Procedure

Ecoguided Percutaneous Neuromodulation over the posterior branch of the cervical multifidus, for 10 minutes, with a frequency of 10 HZ.

Primary outcomes

  1. Pain threshold

    Time frame: up to 1 Week

    Portable hand pressure algometer (FPX 50/220, Wagner Instruments, Greenwich, USA), measured in kg / cm² (kilogram per centimeter squared).

Secondary outcomes

  1. Pain by visual analog scale

    Time frame: Baseline

    usual visual analog scale (VAS) of pain (line from 0: no pain to 10:worst pain)

  2. Pain by visual analog scale

    Time frame: after intervention

    usual visual analog scale (VAS) of pain (line from 0: no pain to 10:worst pain)

  3. Pain by visual analog scale

    Time frame: Follow-up at 1 week

    usual visual analog scale (VAS) of pain (line from 0: no pain to 10:worst pain)

  4. Neck Disability Index Questionnaire.

    Time frame: Baseline

    Quantification of pain and disabilty

  5. Neck Disability Index Questionnaire.

    Time frame: after intervention

    Quantification of pain and disabilty

  6. Neck Disability Index Questionnaire.

    Time frame: Follow-up at 1 week

    Quantification of pain and disabilty

  7. Kinesiophobia

    Time frame: Baseline

    Measured with Tampa Kinesiophobia Scale questionnaire (TSK-11SV) Spanish version. Minimum and maximum values are between 11 and 44 point, a result with higher values indicates higher level of kinesiofobia.

  8. Kinesiophobia

    Time frame: after intervention

    Measured with Tampa Kinesiophobia Scale questionnaire (TSK-11SV) Spanish version. Minimum and maximum values are between 11 and 44 point, a result with higher values indicates higher level of kinesiofobia.

  9. Kinesiophobia

    Time frame: Follow-up at 1 week

    Measured with Tampa Kinesiophobia Scale questionnaire (TSK-11SV) Spanish version. Minimum and maximum values are between 11 and 44 point, a result with higher values indicates higher level of kinesiofobia.

  10. Pain Catastrophizing Scale

    Time frame: Baseline

    Pain Catastrophizing Scale (PAS) will be used to evaluate the participants' pain-related thoughts and feelings.

  11. Pain Catastrophizing Scale

    Time frame: after intervention

    Pain Catastrophizing Scale (PAS) will be used to evaluate the participants' pain-related thoughts and feelings.

  12. Pain Catastrophizing Scale

    Time frame: Follow-up at 1 week

    Pain Catastrophizing Scale (PAS) will be used to evaluate the participants' pain-related thoughts and feelings.

  13. Health-related quality of life

    Time frame: Baseline

    The Short Form Health Questionnaire (SF-36) questionnaire, which examines health-related quality of life under eight sub-titles; It consists of 36 items. The SF36 questionnaire will be used in the study.

  14. Health-related quality of life

    Time frame: after intervention

    The Short Form Health Questionnaire (SF-36) questionnaire, which examines health-related quality of life under eight sub-titles; It consists of 36 items. The SF36 questionnaire will be used in the study.

  15. Health-related quality of life

    Time frame: Follow-up at 1 week

    The Short Form Health Questionnaire (SF-36) questionnaire, which examines health-related quality of life under eight sub-titles; It consists of 36 items. The SF36 questionnaire will be used in the study.

  16. Sonoelastography

    Time frame: Baseline

    This diagnostic test would be executed by a Physiotherapist who has experiences of using General Electric, P9 model ultrasound system for more than three year. The equipment to obtain the image will be used with a frequency of 12 MHz, 22 dB gain, 85 dynamic range, brightness at 17 and depth of 4 cm.

    The transducer will be placed on the spinosa of C4 and the probe will be moved towards the transverse of each of the sides, to identify the image of the multifidus muscle in depth.

    Once the muscle is located in this segment, a longitudinal and transverse image of the muscle will be obtained, performing the elastography at the same time and calculating the elastographic values (tissue resistance in kilopascals and transmission speed in meters/second).

  17. Sonoelastography

    Time frame: after intervention

    This diagnostic test would be executed by a Physiotherapist who has experiences of using General Electric, P9 model ultrasound system for more than three year. The equipment to obtain the image will be used with a frequency of 12 MHz, 22 dB gain, 85 dynamic range, brightness at 17 and depth of 4 cm.

    The transducer will be placed on the spinosa of C4 and the probe will be moved towards the transverse of each of the sides, to identify the image of the multifidus muscle in depth.

    Once the muscle is located in this segment, a longitudinal and transverse image of the muscle will be obtained, performing the elastography at the same time and calculating the elastographic values (tissue resistance in kilopascals and transmission speed in meters/second).

  18. Sonoelastography

    Time frame: Follow-up at 1 week

    This diagnostic test would be executed by a Physiotherapist who has experiences of using General Electric, P9 model ultrasound system for more than three year. The equipment to obtain the image will be used with a frequency of 12 MHz, 22 dB gain, 85 dynamic range, brightness at 17 and depth of 4 cm.

    The transducer will be placed on the spinosa of C4 and the probe will be moved towards the transverse of each of the sides, to identify the image of the multifidus muscle in depth.

    Once the muscle is located in this segment, a longitudinal and transverse image of the muscle will be obtained, performing the elastography at the same time and calculating the elastographic values (tissue resistance in kilopascals and transmission speed in meters/second).

Sponsors and collaborators

Lead sponsor

CEU San Pablo University

Other

Collaborators

  • Universidad Católica de Ávila

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 28, 2024
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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