Effects of percutaneous auricular vagus nerve stimulation in chronic widespread myofascial low back and cervical pain syndrome

Investigation the effectiveness of percutaneous auricular vagus nerve stimulation in chronic widespread myofascial pain syndrome

A block randomised, sham controlled clinical trial with blinded outcome assessment with a parallel group design of of 68 patients

68 patients with diagnosed chronic widespread low back and cervical myofascial pain syndrome are randomly (block randomization) divided into 2 groups. The intervention group is assigned 10 sessions of percutaneous auricular vagus nerve stimulation, while the control group receive shame therapy in private physiotherapy clinics in Kerman. Patients take out the sealed envelopes so the assigned group of that participant is determined. Patients were assessed before and after the 10 sessions using the Visual Analog Scale (VAS) for pain, and also assessed for the presence of trigger points in more prevalent pain sites for each muscle. The outcome measurements included a heart rate variability (HRV) and pressure pain threshold (PPT), Low Back Pain Disability, Neck Disability, Kinesiophobia , Anxiety

Inclusion criteria: 1. Patients in the age range of 25-55 years 2. Having the criteria of lumbar and neck myofascial syndromes based on the criteria provided by Travell and Simon 3- The patient should have pain for at least 3 months. 4- Causing pain of at least 3 out of 10 on the visual scale Exclusion criteria: 1. Neurological, Metabolic and endocrine, Inflammatory and Systemic diseases 2. History of malignancy 3. Pregnancy and Menopause 4. Use of painkillers in the last 24 hours 5. Cardiovascular diseases 6. Taking drugs that affect the autonomic system,

In the treatment group, auricular vagus nerve stimulation is performed in Cymba Concha. In the control group, stimulation in earlobe.

pain; pain pressure threshold; disability

Change the sample size during the sampling process, to increase statistical power and reduce random error, as well as based on a review of other literature, we increased the sample size to 34 participants in each group. This adjustment was made prior to conducting the main statistical analyses and without consideration of preliminary results. Approval for this sample size increase was obtained from the Graduate studies Office of the University of University of Social Welfare and Rehabilitation Sciences as well as from the Ethics Committee.

Patients are divided into two intervention groups (vagus nerve stimulation) and sham group (placebo vagus nerve stimulation) by block randomization. 34 patients are in the intervention group and 34 patients are in the placebo group. 17 blocks are created and there are 4 patients in each block. (2 patients are in the intervention group and 2 patients are in the sham group). The size of the blocks is equal. Election by lots is used between the blocks and people are randomly placed in the blocks based on this election. This method aims to balance the number of samples allocated to each group. People take out the cards that have a random sequence and the letters A (intervention group) and B (placebo group) are written on them from the box (the cards are inside the envelopes, the contents of the envelopes are not clear).In this way, the assigned group of that patient is determined. In order to maintain a random sequence, the envelopes are numbered in the same order. It should be noted that the random sequence of cards and the allocation of patients to treatment groups are not done by one person so that the randomization process is done correctly. In order to prevent the interference of information, the days of the treatment sessions during the week for each group is determined randomly.

Patients are randomly divided into two groups. intervention groups: vagus nerve stimulation and sham group (placebo vagus nerve stimulation). Electrical stimulation is performed in both groups. In the intervention group, electrical stimulation is performed at the distribution site of the vagus nerve (concha and simba conca area of ​​the ear), but in the placebo group, stimulation is applied at the earlobe, which is not the distribution site of the vagus nerve. Therefore, in this way, patients do not know that they are belong to which group. In order to prevent the interference of information, the days of treatment sessions during the week for each groups is determined randomly (even or odd days).

A code is considered for each patient and the data related to variables, primary and secondary outcomes for each patient are entered based on that code and these data can be shared.

Up to one year after the publication of the study results

Our data will be available to researchers in academic and scientific institutions

If it is necessary to perform more statistical analyses on the data or to obtain results other than ours, the data will be accessible.

Mahboobeh Abdolalizadeh, Gmail: mahabd55@gmail.com, Tel: 00989133409234

The applicant submits his/her request via email or phone, and the information and data will be provided to them within 2 weeks after the call.

The applicant should comply confidentiality rules.