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IRCT20221231056994N1 IRCT 2023-01-29 University of social welfare and rehabilitation sciences Effect of vagues nerve stimulation on lumbopelvic pain with constipation Effect of vagues nerve stimulation on lumbopelvic myofascial pain syndrome with chronic functional constipation 2023-08-23 anticipated 46 Complete https://irct.ir/trial/67717 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization is done individually in a sealed envelope. In this two-group trial study, 20 participants are in the intervention group and 20 participants are in the placebo group. With two groups, 5 blocks are created, with 8 people in each block (4 participants in the intervention group and 4 participants in the placebo group). The size of the blocks is equal. A lottery is drawn between the blocks, and people are randomly placed in the blocks based on this lottery. This method aims to balance the number of samples allocated to each of the groups. People take out cards with random sequence and even numbers (intervention group) and odd numbers (placebo group) written on them from the envelope (The cards are inside sealed envelopes, the contents of the envelopes are not clear). In order to maintain the random sequence, the numbering on the envelopes is done in the same order and the lid of the envelopes is glued and placed inside a box. It should be noted that the random sequence of cards and the allocation of participants to treatment groups are not done by one person so that the randomization process is done correctly, Blinding description: The participants are blinded that the stimulation is done in the ear region in both groups, only in the placebo group the stimulation is in the earlobe so the subjects do not know which group they are in. Also, in order to prevent the interference of information, it is determined randomly from among the days of the week which of the two groups will be assigned to each day. N/A Condition 1: lumbopelvic myofascial pain syndrome. Condition 2: chronic functional constipation. Intervention 1: Intervention group: Patients are placed in a room with a temperature of 25±2 degrees in a supine position. In this study, the electroacupuncture is used to stimulate the afferents of auricular branch of vagus nerve in the concha region of the left ear. For this purpose, a continuous two-phase current with a pulse width of 250 microseconds and a frequency of 25 Hz is applied for 30 minutes. In this study, needle are used, which are placed in the mentioned area after cleaning the skin with an alcohol swab. Participants familiarize with the stimulus for 1 minute before starting the therapeutic technique, and then the intensity is slowly increased until it reaches the desired intensity. The stimulation amplitude is adjusted individually before each session to achieve a tingling sensation. This sensation should not be painful to selectively stimulate the Aβ afferent fibers of the vagus nerve. It should be noted that treatment is performed in 10 sessions, one day apart. Intervention 2: Control group: Patients are placed in a room with a temperature of 25±2 degrees in a supine position. In this study, the electroacupuncture is used to stimulate the left earlobe. For this purpose, a continuous two-phase current with a pulse width of 250 microseconds and a frequency of 25 Hz is applied for 30 minutes. In this study, needle are used, which are placed in the mentioned area after cleaning the skin with an alcohol swab. Participants familiarize with the stimulus for 1 minute before starting the therapeutic technique, and then the intensity is slowly increased until the current is felt very little. It should be noted that since there is no treatment in the placebo group, people who are randomly placed in this group will receive 10 free physiotherapy sessions after the completion of the course. Yes - There is a plan to make this available What will be shared: A code is considered for each person, and based on this code, the data related to the variables for each person can be shared after making them unidentifiable. When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: If it is necessary to carry out more statistical analyzes or to report other results in addition to the obtained results. the names of the executive agents should be mentioned when reporting the results. Where to obtain: Fariba Khosravi 09131985863 F.khosravi280@gmail.com How to obtain: The person announces his request through email or phone number. Documents will be provided at most one month after the announcement of the request. Comments: The applicant is required to keep the information confidential.
public Fariba Khosravi
No 3, First floor, East 6, Alley 12, Gohary street, Shahab Ave
Kerman Iran (Islamic Republic of) 7616845553 +98 34 3322 1311 far.khosravi@uswr.ac.ir University of social welfare and rehabilitation sciences scientific Fariba Khosravi
No 3, First floor, East 6, Alley 12, Gohary street, Shahab Ave
Kerman Iran (Islamic Republic of) 7616845553 +98 34 3322 1311 far.khosravi@uswr.ac.ir University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Body mass index less than 30 kg/m2 Having at least two signs of the Rome IV criteria The presence of trigger points in at least 3 muscles from the rectus abdominus, psoas major, iliacus, quadratus lumbarum, piriformis, obturator internus, hamstrings, tensor fascia lata, adductors, gluteus medius, gluteus minimus, gluteus maximus and coccygeus on each side using algometer widespread pain index is equal to or greater than 7 20 years 50 years Female Neurological diseases Metabolic and endocrine diseases Thyroid diseases Infectious and inflammatory diseases Myopathy diseases Cardiovascular diseases Systemic diseases such as scleroderma and lupus Cognitive and psychotic diseases Surgeries of the digestive system Long-term use of corticosteroids Addiction and alcohol consumption Taking drugs that affect the autonomic system (such as cholinergic and anticholinergic drugs and alpha and beta blockers) Pregnancy and menopause History of malignancy Hemorrhoid, fissure and grade 3 and 4 rectal prolapse diseases G89.29 K59.0 Other chronic pain Constipation Treatment - Other Placebo Intervention group: Patients are placed in a room with a temperature of 25±2 degrees in a supine position. In this study, the electroacupuncture is used to stimulate the afferents of auricular branch of vagus nerve in the concha region of the left ear. For this purpose, a continuous two-phase current with a pulse width of 250 microseconds and a frequency of 25 Hz is applied for 30 minutes. In this study, needle are used, which are placed in the mentioned area after cleaning the skin with an alcohol swab. Participants familiarize with the stimulus for 1 minute before starting the therapeutic technique, and then the intensity is slowly increased until it reaches the desired intensity. The stimulation amplitude is adjusted individually before each session to achieve a tingling sensation. This sensation should not be painful to selectively stimulate the Aβ afferent fibers of the vagus nerve. It should be noted that treatment is performed in 10 sessions, one day apart. Control group: Patients are placed in a room with a temperature of 25±2 degrees in a supine position. In this study, the electroacupuncture is used to stimulate the left earlobe. For this purpose, a continuous two-phase current with a pulse width of 250 microseconds and a frequency of 25 Hz is applied for 30 minutes. In this study, needle are used, which are placed in the mentioned area after cleaning the skin with an alcohol swab. Participants familiarize with the stimulus for 1 minute before starting the therapeutic technique, and then the intensity is slowly increased until the current is felt very little. It should be noted that since there is no treatment in the placebo group, people who are randomly placed in this group will receive 10 free physiotherapy sessions after the completion of the course. The complete spontaneous bowel movements per week. Timepoint: Before and after 10 sessions of treatment. Method of measurement: The number of times a person has bowel movements per week. Heart rate variability. Timepoint: Before and after 10 sessions of treatment. Method of measurement: PowerLab data acquisition. Quality of Life scale. Timepoint: Before and after 10 sessions of treatment. Method of measurement: Patient Assessment of Constipation Quality of Life questionnaire. Beck anxiety level. Timepoint: Before and after 10 sessions of treatment. Method of measurement: Beck Anxiety Inventory. Pain pressure threshold. Timepoint: Before and after 10 sessions of treatment. Method of measurement: Algometer. Pain intensity. Timepoint: Before and after 10 sessions of treatment. Method of measurement: Visual Analogue Scale. Severity constipation. Timepoint: Before and after 10 sessions of treatment. Method of measurement: Wexner questionnaire. 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 Kerman Tehran Iran (Islamic Republic of)