Effects of Transcutaneous Neuromodulation and Cervical Exercise in Students With Chronic Nonspecific Cervical Pain

Overview

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.

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.

Interventions

• Other Supervised Cervical Exercise Program
  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 implemen
• Device Low-Frequency Transcutaneous Neuromodulation
  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.
• Device Sham Transcutaneous Neuromodulation
  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.

Primary outcome measures

• Pain Intensity [Time frame: Baseline and week 6]

Secondary outcome measures (4)

• Pressure Pain Threshold [Time frame: Baseline and week 6]
• Joint Position Sense Error [Time frame: Baseline and Week 6]
• Neck Disability [Time frame: Baseline and week 6]
• Depression, anxiety and stress [Time frame: Baseline and week 6]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07452237 · TN AND EXERCISE IN CNCP

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗