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Cervical Manual Therapy and Vagus Nerve Stimulation in Patients With Nonspecific Neck Pain

Investigation of the Effect of Instrument Supported Cervical Manual Therapy Methods and Vagus Nerve Stimulation in Patients With Nonspecific Neck Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06435364
Enrollment
40
Registered
2024-05-30
Start date
2024-05-17
Completion date
2024-08-21
Last updated
2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Syndrome

Brief summary

People with chronic neck pain are becoming more and more common in society every day.

Detailed description

In chronic neck pain investigations, it is generally reported that all people experience neck pain once in my life and more than half of the developed societies experience this problem. It has been stated that 48% of these continue as chronic neck pain, which significantly affects the quality of life due to the postponement of treatment due to its cost.

Interventions

OTHERVagus nerve stimilation

This non-invasive system is activated by the cutaneous distribution of vagus nerve afferents through the external ear. Somatosensory innervation is provided by the auricular branch.

OTHERManual therapy

Manual therapy is mostly defined by the tissue targeted by the practitioner; it can be joint biased, muscle and connective tissue biased and/or neurovascular system biased techniques.

Sponsors

Istanbul Medipol University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

for volunteers and/or study participants; * Presence of neck pain for at least three months * Non-specific neck pain * To have signed the voluntary consent form

Exclusion criteria

for volunteers and/or participants; * Having undergone surgery for the cervical region * Rehabilitation of the neck area at least three months prior to treatment * Traumatic medulla spinalis injury * Neurological deficit * Rheumatological disease * Structural spinal disorders

Design outcomes

Primary

MeasureTime frameDescription
Heart rate variability4 weeksHeart rate variability (HRV) is an indicator of the effects of these two components on the heart, reflecting the variations in the time intervals between heartbeats. High HRV generally indicates good autonomic balance and a healthy cardiovascular system, while low HRV can be a sign of stress, fatigue, or underlying health issues. When sympathetic nervous system activity increases, heart rate accelerates and HRV decreases; conversely, when parasympathetic nervous system activity increases, heart rate slows and HRV increases. Therefore, HRV is an important biomarker for assessing overall health status and developing stress management strategies.
Neck disability index:4 weeksThe neck disability index is the most commonly used functional outcome tool for disabilities in the cervical region. This outcome assessment tool was created by modifying the Oswestry Disability Index and is highly reliable (Chad E. Cook, Amy E. Cook 2011). Scoring is given for each question as A: 0 points, B: 1 point, C: 2 points, D: 3 points, E: 4 points, F: 5 points. The total score gives the test score. According to the test result 0-4=No disability 5-14= Mild disability 15-24= Moderate disability 25-34 = Severe disability
Joint Range of Motion4 weeksRange of motion is the ability of a joint to go through the full range of motion. The range of motion of a joint can be passive or active. Passive ROM - The maximum range of motion through which the joint can move with the aid of external force. Active ROM - the range of motion achieved by contracting and relaxing opposing muscles
The visual analogue scale (VAS)4 weeksThe visual analogue scale (VAS) is a validated, subjective measure of acute and chronic pain. Scores are recorded by placing a handwritten mark on a 10 cm line representing the continuum between no pain and worst pain

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026