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Completed

NCT Number: NCT07577037

Ultrasound-guided Percutaneous Neuromodulation of the Accessory Nerve in Patients With Whiplash Injury

This study evaluates the improvement of patients with whiplash injury by comparing two statistical groups: a control group with exercise alone and an experimental group with exercise and percutaneous musculoskeletal neuromodulation of the accessory nerve. The following variables are evaluated: Neck Disability Index, VAS, cervical ROM, and algometry in the upper trapezius.

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Key information

Conditions

Whiplash Injury of Cervical Spine Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CEU San Pablo

Logroño, La Rioja, 26003, Spain

Who can participate

Healthy volunteers accepted: No

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

The inclusion criteria were as follows:

  • Having suffered a traffic accident within a period not exceeding two weeks prior to the assessment.
  • Diagnosed with Grade I or II Whiplash Associated Disorder (WAD) according to the Quebec Task Force (QTF).
  • Being at least 18 years of age.
  • Have a Visual Analogue Scale (VAS) score greater than 20 mm.
  • Have a cervical disability greater than 10 points according to the NDI.

The exclusion criteria were as follows:

  • Neck pain resulting from previous traffic accidents
  • Conditions that may interfere with full participation (cardiovascular and neurological diseases and severe mental disorders)
  • Treatment prior to starting the study
  • Cervical surgery and congenital spinal disorders
  • Fractures and dislocations of the neck vertebrae
  • Alcohol or drug abuse
  • Allergies to metals
  • Belonephobia

Treatment and study plan

Exercise

Other

The intervention were 13 different exercises. Of the 13 exercises, 6 are specific activation and strength exercises targeting the deep neck muscles, whilst 7 are general neck strength and endurance exercises. The total duration of the programme will be 40 minutes. Following the first session of the exercise programme, a further session was scheduled for later in the week.

Ultrasounded Percutaneous Neuromodulation

Other

This procedure involved inserting a needle into contact with the epineurium of the accessory nerve at neck level and applying electrical stimulation. With the aid of an ultrasound scanner, the physiotherapist performing the procedures approached the epineurium of the accessory nerve using a solid needle (Agupunt® brand, 0.30 mm × 0.40 mm). Stimulation was performed using a compensated biphasic low-frequency current with a frequency of 2 Hz and a pulse width of 250 microseconds for 20 minutes using the FisioInvasiva® 2.0 device (PRIM, Madrid, Spain) via PES (Percutaneal Electrical Stimulation) currents and an electrode to complete the circuit. The procedure is called Ultrasounded Percutaneous Neuromodulation (US-PNM).

Other names: PNM, US-PNM

Primary outcomes

  1. Neck Disability Index (NDI)

    Time frame: From enrollment to the end of the treatment at 4 weeks

    It is a scale that measures neck disability in patients with non-specific neck pain. The scale include 10 questions of 6 items with a score from 0 to 5. 0 means no limitation and 5 great limitation. The scores are added up and through indirect proportionality a percentage is obtained, with 0% being absence of pain and disability and 100% being maximum pain and disability.

Secondary outcomes

  1. Pain threshold in the ascending fibres of the trapezius muscle

    Time frame: From enrollment to the end of treatment at 4 weeks

    To measure the pain threshold of the ascending fibres of the trapezius muscles, pressure algometry was performed on the point of greatest pain described by the patient in the ascending fibres of the trapezius muscles using a conventional algometer.

  2. Active cervical range of motion (ROM)

    Time frame: From enrollment to the end of treatment at 4 weeks

    Cervical ROM was measured using a conventional two-arm goniometer, recording active movements of flexion, extension, left and right lateral flexion, and left and right rotation.

  3. Pain intensity measured using VAS

    Time frame: From enrollment to the end of treatment at 4 weeks

    The VAS is a scale used to assess patients' pain intensity. The VAS consists of a straight line measuring 10 centimetres, where the left end is 0 (no pain) and the right end is 10 (the worst pain imaginable). Participants will indicate on the line the point that best reflects the intensity of their pain at the time of assessment.

Sponsors and collaborators

Lead sponsor

CEU San Pablo University

Other

Registry information

Official study title

Effectiveness of Ultrasound-guided Percutaneous Neuromodulation on the Accessory Nerve for Improving the Degree of Neck Disability in Patients With Whiplash Injury: a Randomised Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 11, 2026
Registry last updated
May 11, 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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