Whiplash Injury of Cervical SpineNCT07577037
Ultrasound-guided Percutaneous Neuromodulation of the Accessory Nerve in Patients With Whiplash Injury
A study testing Exercise and Ultrasounded Percutaneous Neuromodulation in people with Whiplash Injury of Cervical Spine, run by CEU San Pablo University at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Whiplash Injury of Cervical Spine
- What is being tested?
- Exercise and Ultrasounded Percutaneous Neuromodulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 14 Jun 2025to 30 Nov 2025
- 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
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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Exercise, Ultrasounded Percutaneous Neuromodulation
- Keywords
- Percutaneous neuromodulation therapies, Exercise, Whiplash Injury of Cervical Spine
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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 NeuromodulationOther
Also called PNM, US-PNM
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).
| Study group | Role | What they receive |
|---|---|---|
| Control Group: Only exercise | Active comparator | This arm just do exercise, controlled by a phisiotherapist, This group had 13 different exercises. Receives: 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. Receives: Other: Exercise; Other: Ultrasounded Percutaneous Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of the treatment at 4 weeks
Secondary outcomes (3)
Pain threshold in the ascending fibres of the trapezius muscle
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.
Measured: From enrollment to the end of treatment at 4 weeks
Active cervical range of motion (ROM)
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.
Measured: From enrollment to the end of treatment at 4 weeks
Pain intensity measured using VAS
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.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start14 Jun 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whiplash Injury of Cervical SpineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEU San Pablo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Llanos López, CEU San Pablo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577037
- Sponsor's protocol ID
- 1005-25 TFM
- Status last verified
- May 2026
- First submitted
- 10 Mar 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07577037
- Acronym / sponsor ID
- 1005-25 TFM
- Conditions
- Whiplash Injury of Cervical Spine
- Keywords
- Percutaneous neuromodulation therapies, Exercise, Whiplash Injury of Cervical Spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Study start
- 14 Jun 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group: Only exercise | Active comparator | Other: ExerciseThis arm just do exercise, controlled by a phisiotherapist, This group had 13 different exercises. |
| Experimental Groups: US-PNM + exercise | Experimental | Other: Exercise, Other: Ultrasounded Percutaneous NeuromodulationThis arm had to do exercises and have 1 session per week of a ultrasounded percutaneous neuromodulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe 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. | Other | Control Group: Only exercise, Experimental Groups: US-PNM + exercise |
| Ultrasounded Percutaneous NeuromodulationAlso: PNM, US-PNMThis 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 | Experimental Groups: US-PNM + exercise |
Primary outcome
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.
3 secondary outcomes
Pain threshold in the ascending fibres of the trapezius muscle
Time frame: From enrollment to the end of treatment at 4 weeks
Active cervical range of motion (ROM)
Time frame: From enrollment to the end of treatment at 4 weeks
Pain intensity measured using VAS
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Ultrasounded Percutaneous Neuromodulation in people with Whiplash Injury of Cervical Spine, run by CEU San Pablo University 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?
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 11 May 2026. 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?
Neck Disability Index (NDI) (time frame: From enrollment to the end of the treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2026.