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IRCT20210505051187N1 IRCT 2021-06-02 Bojnourd University of Medical Sciences Comparison of the effect of Pharmacologic treatment and Physical therapy on Myofascial Pain Disorders Comparison of the effect of Pharmacologic treatment and Physical therapy on Myofascial Pain Disorders 2021-06-05 anticipated 30 Complete https://irct.ir/trial/56084 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The study has two groups, the first group is treated with Transcutaneous Electrical Nerve Stimulation and Placebo medicine and the second group is treated with medicine and transcutaneous electrical nerve stimulation is given as a placebo (ie the device is turned off), Randomization description: In order to randomize, simple randomization will be used by shuffling the card. In this way, the number 1 is assigned to the first group and the number 2 assigned to the second group. The number 1 is written on 15 cards and the number 2 is written on 15 cards, then the cards are merged (shuffled) and one card is removed and The allocation is recorded and then the card is returned to the card collection, Blinding description: Patients are assigned to the first or second group according to randomization, but do not know the main treatment. 3 myofascial pain disorders. Intervention 1: First intervention group: This group is treated with Transcutaneous Electrical Nerve Stimulation device (manufactured by Novin Company) with high frequency and pulse width of 25 mA. The device is set to 100 Hz while the stimulus intensity is adjusted depending on the patient's tolerance. Stimulation is given to the patient while sitting. Surface electrodes are placed in the sigmoid notch and behind the neck to complete the circuit. Gently wipe the pad location with an isopropyl alcohol to remove skin oils or substances that may interfere with the flow. In men, facial hair should be shaved. Then the pads are inserted and the connection is established. The physiotherapist must adjust the settings according to the patient's sensation. Patients visit a physiotherapist once a week for 4 weeks for treatment with the device. Each treatment session with this method lasts 30 minutes. Prolonged treatment should be avoided, as this device creates a vague pain, which gradually increases in severity, and all operations are performed by a physiotherapist. The first group is also given a placebo medicine. The method of preparation of placebo medicine for similarity in packaging, taste and appearance is that starch is poured into capsules 500 mg (for similarity with naproxen) and 10 mg (for similarity with diazepam). The medicine are prescribed in such a way that both drugs are used twice a day for 10 days. Intervention 2: second Intervention group: This group is treated with the medicine and the capsule of 500 mg Naproxen and the capsule of 2 mg Diazepam are each given twice daily for 10 days. In this group, in order to be similar in terms of packaging, taste and appearance of placebo medicine with the main medicine, 500 mg Naproxen tablet is powdered and poured in the same type of 500 mg capsule and also 2 mg Diazepam is powdered and poured in the same type of 10 mg capsule. In group 2, all treatments with Transcutaneous Electrical Nerve Stimulation are similar to the first intervention group, except that the device is off. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Sahere Soltani
Al-zahra Student Dormitory, Block 1, Alley 6, Shariyar St., Al-Ghadir Complex
Bojnurd Iran (Islamic Republic of) 9415837413 +98 58 3228 9322 yasaminmahjoobi75@gmail.com Bojnourd University of Medical Sciences scientific Sahere Soltani
Al-zahra Student Dormitory, Block 1, Alley 6, Shariyar St., Al-Ghadir Complex
Bojnurd Iran (Islamic Republic of) 9415837413 +98 58 3228 9322 yasaminmahjoobi75@gmail.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) Patients with Myofascial Pain Disorders The chief complaint of acute pain (less than 6 months) on at least one side with / without restriction in opening the mouth no limit no limit Both Other types of Temporomandibular Disorders Systemic joint diseases (such as Rheumatoid arthritis) A recent history of trauma Complete or partial edentulousness Pregnancy Breastfeeding Patients undergoing orthodontic treatment Patients who are unable to use the desired drugs due to systemic problems Patients who used other treatments M26.69 Other specified disorders of temporomandibular joint Treatment - Devices Treatment - Drugs First intervention group: This group is treated with Transcutaneous Electrical Nerve Stimulation device (manufactured by Novin Company) with high frequency and pulse width of 25 mA. The device is set to 100 Hz while the stimulus intensity is adjusted depending on the patient's tolerance. Stimulation is given to the patient while sitting. Surface electrodes are placed in the sigmoid notch and behind the neck to complete the circuit. Gently wipe the pad location with an isopropyl alcohol to remove skin oils or substances that may interfere with the flow. In men, facial hair should be shaved. Then the pads are inserted and the connection is established. The physiotherapist must adjust the settings according to the patient's sensation. Patients visit a physiotherapist once a week for 4 weeks for treatment with the device. Each treatment session with this method lasts 30 minutes. Prolonged treatment should be avoided, as this device creates a vague pain, which gradually increases in severity, and all operations are performed by a physiotherapist. The first group is also given a placebo medicine. The method of preparation of placebo medicine for similarity in packaging, taste and appearance is that starch is poured into capsules 500 mg (for similarity with naproxen) and 10 mg (for similarity with diazepam). The medicine are prescribed in such a way that both drugs are used twice a day for 10 days. second Intervention group: This group is treated with the medicine and the capsule of 500 mg Naproxen and the capsule of 2 mg Diazepam are each given twice daily for 10 days. In this group, in order to be similar in terms of packaging, taste and appearance of placebo medicine with the main medicine, 500 mg Naproxen tablet is powdered and poured in the same type of 500 mg capsule and also 2 mg Diazepam is powdered and poured in the same type of 10 mg capsule. In group 2, all treatments with Transcutaneous Electrical Nerve Stimulation are similar to the first intervention group, except that the device is off. Pain. Timepoint: At the beginning of the intervention and 10 days after the beginning of the intervention and at the end of the intervention. Method of measurement: The visual Analogue Scale is used to record the amount of pain, which is zero without pain and 10 is the highest amount of pain imaginable for the patient. At each assessment session, the patient should mark their pain on a visual analogue scale. Maximum mouth opening without pain. Timepoint: At the beginning of the intervention and 10 days after the beginning of the intervention and at the end of the intervention. Method of measurement: Distance between incisal edge of maxillary and mandibular incisors at Maximum mouth opening without pain. Bojnourd University of Medical Sciences Approved 2021-05-02 Ethics committee of North Khorasan University of Medical Sciences Al-zahra Student Dormitory, Block 1, Alley 6, Shariyar St., Al-Ghadir Complex Bojnurd North Khorasan Iran (Islamic Republic of)