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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06435364
Other study ID # E-10840098-202.3.02-2983
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 17, 2024
Est. completion date August 21, 2024

Study information

Verified date May 2024
Source Istanbul Medipol University Hospital
Contact Hazal GENÇ, PhD
Phone 05413204291
Email hazaloksuz@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date August 21, 2024
Est. primary completion date June 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Vagus 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.
Manual 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.

Locations

Country Name City State
Turkey Bahçehir University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Autonomic nervous system device Device is a heart rate sensor with the gold standard in high precision and accuracy that comes with a wearable chest strap. It can be connected to multiple training devices via Bluetooth and ANT+. The device features a soft, adjustable sensor that contacts the chest to capture heart rate in real time. 4 weeks
Primary Neck disability index: 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
4 weeks
Primary Joint Range of Motion 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 weeks
Primary The visual analogue scale (VAS) 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" 4 weeks
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