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

NCT06435364 | Completed

• 1 other identifier: E-10840098-202.3.02-2983
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain Syndrome

Outcome Measures

Primary Outcomes (4)

• Heart rate variability

  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.

  4 weeks

• 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

• 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

• 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

Study Arms (2)

Vagus nerve

EXPERIMENTAL

This non-invasive system is activated by the cutaneous distribution of vagus nerve afferents via the external ear.

Other: Vagus nerve stimilation

Manual therapy

ACTIVE COMPARATOR

Manual therapy is effective in the treatment of musculoskeletal pain.

Other: Manual therapy

Interventions

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.

Vagus nerve

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.

Manual therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Presence of neck pain for at least three months
• Non-specific neck pain
• To have signed the voluntary consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Bahçehir University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Somatoform Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 30, 2024
• Study Start: May 17, 2024
• Primary Completion: June 15, 2024
• Study Completion: August 21, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

TU (1)