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IRCT20221230056989N1 IRCT 2023-01-30 University of social welfare and rehabilitation sciences Effects of percutaneous auricular vagus nerve stimulation in chronic widespread myofascial pain syndrome Effects of percutaneous auricular vagus nerve stimulation in chronic widespread myofascial low back and cervical pain syndrome 2023-08-23 anticipated 68 Complete https://irct.ir/trial/67714 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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). N/A Chronic Widespread Myofascial Low Back and Cervical Pain Syndrome. Intervention group: The intervention group is assigned 10 sessions of percutaneous auricular vagus nerve stimulation (biphasic rectangular with 250 microseconds pulse and 25 Hz) is applied for 30 minutes in conchae and cymba conchae area of ear (site of distribution of the auricular vagus nerve). Shame group: 10 sessions stimulation in earlobe (biphasic rectangular with 250 microseconds pulse and 25 Hz) which is not the site of distribution of the vagus nerve.. Yes - There is a plan to make this available What will be shared: 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. When: Up to one year after the publication of the study results To whom: Our data will be available to researchers in academic and scientific institutions Conditions: If it is necessary to perform more statistical analyses on the data or to obtain results other than ours, the data will be accessible. Where to obtain: Mahboobeh Abdolalizadeh, Gmail: mahabd55@gmail.com, Tel: 00989133409234 How to obtain: 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. Comments: The applicant should comply confidentiality rules.
public Mahboobeh Abdolalizadeh
Alley 11, Vesal St, Jomhoori Eslami Blvd, Kerman, Iran
Kerman Iran (Islamic Republic of) 7618471911 +98 34 3265 3297 mahabd55@gmail.com University of social welfare and rehabilitation sciences scientific Mahboobeh Abdolalizadeh
Alley 11, Vesal St, Jomhoori Eslami Blvd, Kerman, Iran
Kerman Iran (Islamic Republic of) 7618471911 +98 34 3265 3297 mahabd55@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Patients in age 25 to 55 years Body mass index less than 30 kg/m2 Having the criteria of lumbar and neck myofascial syndromes based on the criteria provided by Travell and Simon in the muscles of the back and neck the patient have pain for at least 3 months. The presence of at least 3 trigger points in the muscles of the back and neck, where one of these two areas involves the muscles bilaterally (by using an algometer, as well as by touch) Intensity of pain of at least 3 out of 10 on the Visual Analog Scale (VAS) Patients whose Wide Spread Pain Index (WPI) is equal to or greater than 7 25 years 55 years Both Neurological diseases Metabolic and endocrine diseases Systemic diseases such as lupus, scleroderma Infectious diseases Inflammatory diseases Thyroid diseases History of malignancy Diabetes Pregnancy Menopause Use of painkillers in the last 24 hours Long-term use of corticosteroids Drug addiction Cognitive and psychotic diseases Myopathies Cardiovascular diseases Taking drugs that affect the autonomic system, such as cholinergic and anticholinergic drugs, alpha and beta blockers, antipsychotics G89.4 Chronic pain syndrome Treatment - Other Intervention group: The intervention group is assigned 10 sessions of percutaneous auricular vagus nerve stimulation (biphasic rectangular with 250 microseconds pulse and 25 Hz) is applied for 30 minutes in conchae and cymba conchae area of ear (site of distribution of the auricular vagus nerve). Shame group: 10 sessions stimulation in earlobe (biphasic rectangular with 250 microseconds pulse and 25 Hz) which is not the site of distribution of the vagus nerve. Heart Rate Variability (HRV). Timepoint: Before and after 10 sessions. Method of measurement: PowerLab data acquisition system. Low Back Pain Disability. Timepoint: Before and after 10 sessions. Method of measurement: Oswestry Low Back Pain Disability (ODI). Low Back Pain Diability. Timepoint: Before and after 10 sessions. Method of measurement: Roland-Morris Disability Questionnaire (RMQ). Neck Disability. Timepoint: Before and after 10 sessions. Method of measurement: Neck Disability Index (NDI). Kinesiophobia. Timepoint: Before and after 10 sessions. Method of measurement: Tampa Scale of Kinesiophobia (TSK). Anxiety. Timepoint: Before and after 10 sessions. Method of measurement: Beck Anxiety Inventory (BAI). Heart Rate Variability. Timepoint: Before and after 10 sessions. Method of measurement: PowerLab data acquisition system. Pain Pressure Threshold (PPT). Timepoint: before and after 10 sessions. Method of measurement: algometer. Pain. Timepoint: before and after 10 sessions. Method of measurement: Visual Analog Scale (VAS). University of social welfare and rehabilitation sciences Approved 2023-01-18 Research ethics committees of University of Social Welfare and Rehabilitation Sciences kodakyar Ave., daneshjo Blvd.,Evin, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran Post code: : 1985713871 Tehran Tehran Iran (Islamic Republic of)