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

Not Applicable

Completed

• Conditions: Pain Syndrome
• Interventions: Other: Vagus nerve stimilation; Other: Manual therapy

• Registration Number: NCT06435364
• Lead Sponsor: Istanbul Medipol University Hospital

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.

Study Timeline

• Study Start: 2024-05-17
• Study First Submitted: 2024-05-24
• Study First Submitted QC: 2024-05-24
• Study First Posted: 2024-05-30
• Primary Completion: 2024-06-15
• Study Completion: 2024-08-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vagus nerve	Vagus nerve stimilation	This non-invasive system is activated by the cutaneous distribution of vagus nerve afferents via the external ear.
Manual therapy	Manual therapy	Manual therapy is effective in the treatment of musculoskeletal pain.

Primary Outcome Measures

Name	Time	Method
Heart rate variability	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.
Neck disability index:	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
The visual analogue scale (VAS)	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"
Joint Range of Motion	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

Trial Locations

Locations (1)

Bahçehir University; 🇹🇷 Istanbul, Turkey