Auricular Vagus Nerve Stimulation For Fibromyalgia Syndrome

NCT04260906 | Completed

• 1 other identifier: Vagusstim
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fibromyalgia Syndrome; Auricular Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• Short Form-36 Score

  Life quality of patients was evaluated using the SF-36 life quality scale. The Turkish validity and reliability of this scale was carried out by Koçyiğit et al. Investigating life quality regarding overall health, this questionnaire contains 36 questions in 8 different categories. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate.

  4 weeks

Study Arms (2)

Vagus nerve stimulation

ACTIVE COMPARATOR

Patients were admitted to the treatment as day visitors. 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 . 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.

Device: Vagus nerve stimulator

exercise

ACTIVE COMPARATOR

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.

Other: exercise

Interventions

Vagus nerve stimulator DEVICE

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.

Vagus nerve stimulation

exercise OTHER

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.

exercise

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females 18- 50 of age

You may not qualify if:

• Pregnancy
• Menopause,
• Neurological deficits
• Diabetes
• Neuropathic disorders
• Chronic inflammation
• Immune deficiency
• Cardiac disorders
• Current drug usage
• Vasovagal syncope

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Bahcesehir University

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

• Wennemer HK, Borg-Stein J, Gomba L, Delaney B, Rothmund A, Barlow D, Breeze G, Thompson A. Functionally oriented rehabilitation program for patients with fibromyalgia: preliminary results. Am J Phys Med Rehabil. 2006 Aug;85(8):659-66. doi: 10.1097/01.phm.0000228677.46845.b2.

  PMID: 16865020 RESULT

• Gebre M, Woodbury A, Napadow V, Krishnamurthy V, Krishnamurthy LC, Sniecinski R, Crosson B. Functional Magnetic Resonance Imaging Evaluation of Auricular Percutaneous Electrical Neural Field Stimulation for Fibromyalgia: Protocol for a Feasibility Study. JMIR Res Protoc. 2018 Feb 6;7(2):e39. doi: 10.2196/resprot.8692.

  PMID: 29410385 RESULT

• Hamer HM, Bauer S. Lessons learned from transcutaneous vagus nerve stimulation (tVNS). Epilepsy Res. 2019 Jul;153:83-84. doi: 10.1016/j.eplepsyres.2019.02.015. Epub 2019 Feb 26.

  PMID: 30952581 RESULT

• Straube A, Ellrich J, Eren O, Blum B, Ruscheweyh R. Treatment of chronic migraine with transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS): a randomized, monocentric clinical trial. J Headache Pain. 2015;16:543. doi: 10.1186/s10194-015-0543-3. Epub 2015 Jul 9.

  PMID: 26156114 RESULT

MeSH Terms

Conditions

Fibromyalgia; Myofascial Pain Syndromes

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• kerem alptekin

  Bahçeşehir University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of health sciences institute

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 7, 2020
• Study Start: November 1, 2017
• Primary Completion: February 1, 2019
• Study Completion: May 1, 2019
• Last Updated: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)