Chronic Non-specific Neck PainTN-E-CNCPNCT07452237
Effects of Transcutaneous Neuromodulation and Cervical Exercise in Students With Chronic Nonspecific Cervical Pain
A study testing Supervised Cervical Exercise Program and Low-Frequency Transcutaneous Neuromodulation in people with Chronic Non-specific Neck Pain, run by Universidad Francisco de Vitoria.
Trial summary
This randomized controlled trial aims to compare the effectiveness of a cervical exercise program, transcutaneous neuromodulation of the spinal accessory nerve, and a placebo intervention on pain intensity, pressure pain threshold, cervical proprioception, functional disability, depression, anxiety, and stress in… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Chronic Non-specific Neck Pain
- What is being tested?
- Supervised Cervical Exercise Program and Low-Frequency Transcutaneous Neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Jul 2026
- Phase
- Interventional
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 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- University students aged 18-30 years
- Chronic non-specific neck pain lasting ≥ 3 months
- Pain intensity >3/10 on VAS
- No pharmacological or physiotherapy treatment in the past 3 months
Who cannot join
- Specific cervical pathology (e.g., radiculopathy)
- Neurological, cardiovascular, systemic, or infectious disease
- Diagnosed psychological disorders
- Pregnancy or postpartum period < 1 year
- Regular use of analgesics, opioids, or antidepressants
- Previous cervical spine or shoulder surgery
- Electronic implants
- Neck pain associated with vertigo
About this study
This randomized controlled trial aims to compare the effectiveness of a cervical exercise program, transcutaneous neuromodulation of the spinal accessory nerve, and a placebo intervention on pain intensity, pressure pain threshold, cervical proprioception, functional disability, depression, anxiety, and stress in university students with chronic non-specific neck pain. The study will include a six-week intervention period with pre- and post-treatment assessments. The findings may contribute to the development of accessible physiotherapy interventions within university settings.
Read the detailed description
Chronic non-specific neck pain is one of the most prevalent musculoskeletal disorders worldwide and represents a significant socioeconomic burden. It affects a large proportion of the adult population and shows increasing prevalence among university students, largely associated with prolonged electronic device use and sustained static postures. Chronic neck pain is defined as pain lasting three months or longer without a specific identifiable pathology.
Psychosocial factors such as stress, anxiety, and depression have been strongly associated with the onset and persistence of neck pain. These factors may contribute to functional disability and reduced quality of life. In university students, persistent neck pain may also negatively impact concentration and academic performance.
Exercise therapy targeting deep cervical flexor muscles has demonstrated improvements in pain, muscular endurance, posture, and functional outcomes in individuals with chronic non-specific neck pain. Additionally, prolonged upper trapezius muscle spasm and possible involvement of the spinal accessory nerve have been suggested as contributing mechanisms in chronic neck pain. Low-frequency electrical stimulation (below 10 Hz), particularly at 4 Hz, has been associated with analgesic effects mediated by endogenous opioid mechanisms.
Placebo interventions have also been shown to activate endogenous analgesic pathways involving cortical and subcortical pain modulation circuits, emphasizing the relevance of patient expectations in rehabilitation outcomes.
This study will compare cervical exercise, transcutaneous neuromodulation of the spinal accessory nerve, and a placebo intervention in a randomized, controlled, parallel-group design with blinded outcome assessment. Both physical and psychosocial variables will be evaluated before and after a six-week intervention period.
- Conditions
- Chronic Non-specific Neck Pain
- Being tested
- Supervised Cervical Exercise Program, Low-Frequency Transcutaneous Neuromodulation, Sham Transcutaneous Neuromodulation
- Keywords
- Chronic Non-Specific Neck Pain, Neck Pain, University Students, Cervical Exercise, Deep Cervical Flexor Training, Transcutaneous Neuromodulation, Low-Frquency Electrical Stimulation
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Cervical Exercise ProgramOther
Participants will perform a supervised cervical and scapular strengthening program focused on deep cervical flexor activation and motor control. The intervention will consist of 12 sessions over six weeks (two sessions per week). Exercises will include cranio-cervical flexion movements, isometric contractions in supine, prone, and side-lying positions, and progressive load adjustments guided by the Borg Rating of Perceived Exertion Scale (target intensity 7/10). Load progression will be implemented after week three to maintain training intensity.
Low-Frequency Transcutaneous NeuromodulationDevice
Participants will receive low-frequency electrical stimulation applied bilaterally over the spinal accessory nerve at Erb's point using the Pointer Excel II device. Stimulation parameters will be set at 4 Hz for 5 minutes per side during each session. The intervention will be delivered twice weekly for six weeks.
Sham Transcutaneous NeuromodulationDevice
Participants will undergo a simulated neuromodulation procedure using the same device and positioning as the active neuromodulation group. No electrical current will be delivered. The device will remain in point-detection mode to produce sound without stimulation. The duration and frequency of sessions will match the active intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Cervical Exercise Program | Experimental | Participants will perform a supervised cervical and scapular strengthening program focused on deep cervical flexor activation and motor control. The intervention will consist of 12 sessions over six weeks (two sessions per week). Exercises will include cranio-cervical flexion movements, isometric contractions in supine, prone, and side-lying positions, and progressive load adjustments guided by the Borg Rating of Perceived Exertion Scale (target intensity 7/10). Load progression will be implemented after week three to maintain training intensity. Receives: Other: Supervised Cervical Exercise Program |
| Low-Frequency Transcutaneous Neuromodulation | Experimental | Participants will receive low-frequency electrical stimulation applied bilaterally over the spinal accessory nerve at Erb's point using the Pointer Excel II device. Stimulation parameters will be set at 4 Hz for 5 minutes per side during each session. The intervention will be delivered twice weekly for six weeks. Receives: Device: Low-Frequency Transcutaneous Neuromodulation |
| Sham Transcutaneous Neuromodulation | Sham comparator | Participants will undergo a simulated neuromodulation procedure using the same device and positioning as the active neuromodulation group. No electrical current will be delivered. The device will remain in point-detection mode to produce sound without stimulation. The duration and frequency of sessions will match the active intervention group. Receives: Device: Sham Transcutaneous Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity will be assessed using a 0-10 Visual Analog Scale, where 0 represents no pain and 10 represents the worst imaginable pain.
Measured: Baseline and week 6
Secondary outcomes (4)
Pressure Pain Threshold
Pressure Pain Threshold (PPT) will be assessed using a validated digital algometer (Digital Force Gauge SF-500). Progressive pressure will be applied at a rate of 1 kg/cm² per second over a 1 cm² surface area at two bilateral anatomical sites: the midpoint between C7 and the acromion (upper trapezius muscle) and the sternocleidomastoid muscle belly. Participants will be positioned supine during assessment. The measurement will stop when the participant verbally indicates the first sensation of pain. Three measurements will be taken at each site with 30-second intervals between trials. The mean value of the three trials will be recorded in kg/cm². Higher values indicate greater pressure pain tolerance.
Measured: Baseline and week 6
Joint Position Sense Error
Cervical proprioception will be evaluated using the Joint Position Sense Error (JPSE) test. Participants will be seated 90 cm from a visual target with a laser pointer attached to the forehead to establish a neutral head position. After familiarization with eyes open, participants will perform cervical flexion-extension, left rotation, and right rotation movements with eyes closed and attempt to return to the initial neutral position. The angular deviation between the starting reference point and the repositioned point will be measured in degrees. The absolute error value will be recorded. Higher values indicate greater proprioceptive impairment.
Measured: Baseline and Week 6
Neck Disability
Functional disability related to neck pain will be assessed using the validated Spanish version of the Neck Disability Index (NDI). The NDI consists of 10 items evaluating pain intensity and the impact of neck pain on activities of daily living (personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation). Each item is scored from 0 to 5. The total score (0-50) will be converted to a percentage using the formula: (total score/50) × 100. Higher percentages indicate greater disability.
Measured: Baseline and week 6
Depression, anxiety and stress
Psychological symptoms will be assessed using the Depression Anxiety Stress Scales-21 (DASS-21). This self-reported questionnaire includes 21 items divided into three subscales (depression, anxiety, and stress), with 7 items per subscale. Each item is rated on a 4-point Likert scale from 0 ("Did not apply to me at all") to 3 ("Applied to me very much or most of the time") based on the past week. Subscale scores will be calculated by summing the corresponding items and multiplying by two, as recommended for the short version. Higher scores indicate greater emotional distress.
Measured: Baseline and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion13 May 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-specific Neck PainStudies 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
- Outcomes assessor
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Roldán, Universidad Francisco de Vitoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452237
- Sponsor's protocol ID
- TN AND EXERCISE IN CNCP
- Acronym
- TN-E-CNCP
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No