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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07577037
Enrollment
44
Registered
2026-05-11
Start date
2025-06-14
Completion date
2025-11-30
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Whiplash Injury of Cervical Spine

Keywords

Percutaneous neuromodulation therapies, Exercise, Whiplash Injury of Cervical Spine

Brief summary

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.

Interventions

OTHERExercise

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.

OTHERUltrasounded Percutaneous Neuromodulation

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).

Sponsors

CEU San Pablo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Neck Disability Index (NDI)From enrollment to the end of the treatment at 4 weeksIt 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

MeasureTime frameDescription
Pain threshold in the ascending fibres of the trapezius muscleFrom enrollment to the end of treatment at 4 weeksTo 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.
Active cervical range of motion (ROM)From enrollment to the end of treatment at 4 weeksCervical 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.
Pain intensity measured using VASFrom enrollment to the end of treatment at 4 weeksThe 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 12, 2026