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

Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06435364
• Other study ID #: E-10840098-202.3.02-2983
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Neck Pain
• Pain Syndrome

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