A Comparative Study on the Effect of Vagus Nerve Stimulation and Ischemic Compression on Trapezius Trigger Points
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Pain Pressure Threshold (Algometer)
Study Overview
Brief Summary
This randomized controlled trial aimed to evaluate the efficacy of non-invasive vagus nerve stimulation (nVNS) compared to ischemic compression (trigger point massage) and exercise in treating trigger points in the upper trapezius muscle. Ninety participants aged 18-55 with at least two trigger points were randomly assigned to three groups: nVNS, ischemic compression, or exercise (control). Interventions were administered over 10 sessions (3 times per week). Outcomes included pain intensity (Visual Analog Scale, VAS), trigger point number, pain pressure threshold (algometer), neck function (Copenhagen Neck Functional Disability Scale, KBFÖS), well-being (WHO-5 Well-Being Index), and functional mobility. The nVNS group demonstrated statistically significant improvements in all outcomes compared to the other groups (p < 0.05).
Detailed Description
Myofascial pain syndrome (MPS) is characterized by trigger points-hyperirritable spots in skeletal muscle associated with pain, stiffness, and reduced function. The upper trapezius muscle is a common site for trigger points, contributing to neck pain and disability. Traditional treatments include ischemic compression and exercise, but non-invasive vagus nerve stimulation (nVNS) has emerged as a promising modality due to its ability to modulate pain pathways and autonomic function.
This study investigated whether nVNS is more effective than ischemic compression or exercise in reducing pain and improving function in patients with trapezius trigger points. Participants were randomized into three groups (n=30 each)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
This study employs single blinding, where the outcomes assessors are masked to the participants' group assignments. Participants are randomized into one of three groups (non-invasive vagus nerve stimulation, ischemic compression, or exercise), and the interventions are administered by unblinded study personnel. To minimize bias, assessors responsible for measuring outcomes, including pain intensity (Visual Analog Scale), number of trigger points, pain pressure threshold (algometer), neck function (Copenhagen Neck Functional Disability Scale), well-being (WHO-5 Well-Being Index), and functional mobility, are unaware of the intervention each participant receives. Participants and intervention providers are not blinded due to the nature of the interventions.
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-55 years.
- •Presence of at least two trigger points (active or latent) in the upper trapezius muscle, confirmed by palpation.
- •Ability to provide informed consent.
Exclusion Criteria
- •History of cervical spine surgery or trauma.
- •Neurological disorders (e.g., epilepsy, stroke).
- •Pregnancy or breastfeeding.
- •Use of pacemakers or other implanted electrical devices.
- •Active infection or skin lesions at the stimulation site.
- •Recent use of botulinum toxin or other trigger point injections.
Outcomes
Primary Outcomes
Pain Pressure Threshold (Algometer)
Time Frame: Measurements were taken pre- and post-intervention. (week 4)
Measured using a digital algometer (kg/cm²) at trigger point sites to assess pain sensitivity.
Pain Intensity (VAS)(Visual Analog Scale )
Time Frame: Baseline and post-intervention (week 4)
Measured using the Visual Analog Scale (0-10 ), where 0 indicates no pain and 10 indicates worst possible pain.
Number of Trigger points
Time Frame: Measurements were taken pre- and post-intervention.(week 4)
Count of active and latent trigger points in the upper trapezius muscle, assessed by palpation.
Neck Function (CNFDS(Copenhagen Neck Functional Disability)
Time Frame: Measurements were taken pre- and post-intervention. (week 4)
Assessed using the Copenhagen Neck Functional Disability Scale, evaluating neck-related disability (0-30, higher scores indicate greater disability).
WHO-5(World Health Organization-Five Well-Bing Index)
Time Frame: Measurements were taken pre- and post-intervention. (week 4)
Description: Measured using the WHO-5 Well-Being Index, a 5-item scale (0-25, higher scores indicate better well-being)
Pain Intensity (VAS)(Visual Analog Scale )
Time Frame: Baseline and post-intervention (week 4)
Measured using the Visual Analog Scale (0-10 ), where 0 indicates no pain and 10 indicates worst possible pain.
Secondary Outcomes
No secondary outcomes reported
Investigators
Shahla Hassanilar Ansaroudi
Principal Investigator,Mcs. Physiotherapy and Rehabilitation Department ,Bahçeşehir University
Bahçeşehir University