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

NCT07577037 | Completed

• 1 other identifier: 1005-25 TFM
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Whiplash Injury of Cervical Spine

Keywords

Percutaneous neuromodulation therapies; Exercise; Whiplash Injury of Cervical Spine

Outcome Measures

Primary Outcomes (1)

• Neck Disability Index (NDI)

  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.

  From enrollment to the end of the treatment at 4 weeks

Secondary Outcomes (3)

• Pain threshold in the ascending fibres of the trapezius muscle

  From enrollment to the end of treatment at 4 weeks

• Active cervical range of motion (ROM)

  From enrollment to the end of treatment at 4 weeks

• Pain intensity measured using VAS

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

Control Group: Only exercise

ACTIVE COMPARATOR

This arm just do exercise, controlled by a phisiotherapist, This group had 13 different exercises.

Other: Exercise

Experimental Groups: US-PNM + exercise

EXPERIMENTAL

This arm had to do exercises and have 1 session per week of a ultrasounded percutaneous neuromodulation.

Other: Exercise; Other: Ultrasounded Percutaneous Neuromodulation

Interventions

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.

Control Group: Only exercise; Experimental Groups: US-PNM + exercise

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).

Also known as: PNM, US-PNM

Experimental Groups: US-PNM + exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CEU San Pablo University: lead

Study Sites (1)

CEU San Pablo

Logroño, La Rioja, 26003, Spain

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, student of Master

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: May 11, 2026
• Study Start: June 14, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

ES (1)