NCT07452237

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

1 month

First QC Date

February 27, 2026

Last Update Submit

March 5, 2026

Conditions

Keywords

Chronic Non-Specific Neck PainNeck PainUniversity StudentsCervical ExerciseDeep Cervical Flexor TrainingTranscutaneous NeuromodulationLow-Frquency Electrical Stimulation

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and week 6

Secondary Outcomes (4)

  • Pressure Pain Threshold

    Baseline and week 6

  • Joint Position Sense Error

    Baseline and Week 6

  • Neck Disability

    Baseline and week 6

  • Depression, anxiety and stress

    Baseline and week 6

Study Arms (3)

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.

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.

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.

Device: Sham Transcutaneous Neuromodulation

Interventions

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.

Supervised Cervical Exercise Program

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.

Low-Frequency 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.

Sham Transcutaneous Neuromodulation

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 5, 2026

Study Start

April 1, 2026

Primary Completion

May 13, 2026

Study Completion

July 1, 2026

Last Updated

March 9, 2026

Record last verified: 2026-03