Auricular Vagus Nerve Stimulation For Fibromyalgia Syndrome

Summary

The purpose of this study is to evaluate the impact of auricular vagus nerve stimulation, applied in conjunction with an exercise treatment program, on pain and life quality in patients with Fibromyalgia Syndrome (FMS). To achieve the study objectives, 60 female patients between the ages 18 - 50, with diagnosed FMS according to American College of Rheumatology (ACR) 2010 diagnostic criteria, were randomly divided into 2 groups of 30. The first group was assigned 20 sessions of a home-based exercise program, while the second group was assigned 20 sessions of auricular vagus nerve stimulation and 20 sessions of a home-based exercise program. Patients were assessed before and after the treatments using the Visual Analog Scale (VAS) for pain, Beck Depression Scale for depression, Beck Anxiety Scale for anxiety, Fibromyalgia Impact Questionnaire (FIQ) for functional evaluation and Short Form-36 (SF-36) for life quality.

In this randomized controlled trial, comparisons within the groups revealed that both groups had statistically significant improvements in pain, depression, anxiety, functionality and life quality scores (p\<0.05), whilst comparisons across the groups revealed that the group experiencing the vagus nerve stimulation had no statistically significant differences between the baseline scores, except for those of SF-36's sub-parameters of physical function, social functionality and pain. In fact comparisons across the groups after the interventions revealed that the group experiencing the vagus nerve stimulation had better scores but not statistically significant. From analysis of this data, the investigators observed that vagus nerve stimulation in FMS treatment did not give additional benefit together with exercise, except for three sub-parameters of SF-36. It was identified that further studies which separately investigate the effects of vagus nerve stimulation and exercise on FMS with longer follow-up periods and an increased number of patients are needed.

Conditions

• Fibromyalgia
• Myofascial Pain Syndrome

Interventions

DEVICE

Vagus nerve stimulator

Vagus nerve stimulation is carried out with a TENS device, which has specially designed surface electrodes in the shape of earphones, the size of which can be selected according to ear size. Electrodes were placed to correspond with the inner and rear surfaces of the tragus and the concha for both ears (Figure 1). The application is carried out, for 30 minutes, using a biphasic, asymmetrical waveform with a pulse duration that is less than 500 microseconds and a frequency of 10 Hertz.

OTHER

exercise

The exercise group was assigned a program, which consisted of strengthening, stretching, isometric and posture exercises, targeting the body and upper and lower extremities. That program was home-based and the program was requested to be completed. Patients were asked to attend weekly face to face sessions with a total of 4 of these sessions in the study duration.

Sponsors & Collaborators

• Bahçeşehir University

  lead OTHER

Principal Investigators

• kerem alptekin · Bahçeşehir University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-01

Primary Completion

2019-02-01

Completion

2019-05-01

Countries

• Turkey (Türkiye)

Study Locations