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Completed

NCT Number: NCT06435364

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

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

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Key information

Conditions

Pain Syndrome Mental Disorders Somatoform Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bahçehir University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vagus nerve stimilation

Other

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.

Manual therapy

Other

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.

Primary outcomes

  1. Heart rate variability

    Time frame: 4 weeks

    Heart 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.

  2. Neck disability index:

    Time frame: 4 weeks

    The 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

  3. Joint Range of Motion

    Time frame: 4 weeks

    Range 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

  4. The visual analogue scale (VAS)

    Time frame: 4 weeks

    The 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"

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 30, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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