]>
IRCT20210226050508N1 IRCT 2021-05-31 Iran University of Medical Sciences Assessment of therapeutic effects of Iranian Nava musical dastgah on Sciatica and comparing it with the conventional medical treatment: a randomised control trial Assessment of therapeutic effects of Iranian Nava musical dastgah on Sciatica and comparing it with the conventional medical treatment: a randomised control trial 2021-06-22 anticipated 112 Complete https://irct.ir/trial/55275 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This is the first clinical study dedicated specifically to the therapeutic effects of the Iranian Nava music Dastgah, Randomization description: Randomisation method: stratified randomization; unit of randomization: odds and even; randomization layers: moderate to severe pain severity; randomization tool: first, the recruits are divided into moderate and severe groups according to the pain severity, then in each category, randomization is performed by block method. Quadruple blocks are selected using a random number table and a random list is prepared. Concealment: a sealed envelope is used. The patient number is written on the envelope and inside the A&B group envelope, Blinding description: In this study, those who cared for patients and provided them with lottery bags and music, and those who collected data and analyzers did not know the study groups. N/A Low back pain (Sciatica). Intervention 1: Intervention group: along side receiving standard treatment and care, every night, the recruits in the intervention group listens to a musical piece in "Mirza abdollah" Radif and Iranian "Nava" musical dastgah for 5 minutes. This piece is performed by Master Aliasghar Bayani using a "Setar" instrument. Intervention 2: Control group: The recruits in control group receive standard treatment and care. the standard care includes home rest, warm compression of the pain field, and 500 mg acetaminophen tablet intake (1-4 tabs per day in relation to the patient's pain). 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 Mona Haghighi
School of Traditional Medicine, No 847, Behesht St. South Side of Shahr Park, Vahdat-e-Islami St., Hasan Abad Sq., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1114733311 +9855580388 dr.mona.haghighi@gmail.com Iran University of Medical Sciences scientific Mona Haghighi
No 847, Behesht St. South Side of Shahr Park, Vahdat-e-Islami St., Hasan Abad Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1114733311 +98 21 5558 0388 dr.mona.haghighi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Diagnosis of sciatica or radicular low back pain (low back pain spreading to the lower limbs below the knee) based on clinical examination or MRI Less than two weeks after the onset of pain (continuous or intermittent) Age: 35 to 65 years old Moderate to severe pain intensity at the start of treatment (VAS greater than or equal to 4) No indication for lumbar spine surgery No hearing problems No history of seizures and noise-aggravated brain lesions(Reflex Epilepsy ) Fluency in Persian 35 years 65 years Both Age less than 35 and more than 65 History of previous lumbar spine surgery Symptoms of cauda equina‏ syndrome (numbness and weakness of both legs, anal pain, perineal anesthesia, sphincter paralysis) Existence of low back pain with specific causes such as fractures, cancer, systemic inflammation and rheumatic diseases, infection and severe degenerative changes Symptoms during treatment that the doctor thinks need further investigation and intervention, such as diseases of other organs Pregnancy Causes hearing problems or noise-aggravated brain damage A history of corticosteroid or opioid use in the last six weeks for any reason Patient dissatisfaction M54.30 Sciatica, unspecified side Treatment - Other Treatment - Drugs Intervention group: along side receiving standard treatment and care, every night, the recruits in the intervention group listens to a musical piece in "Mirza abdollah" Radif and Iranian "Nava" musical dastgah for 5 minutes. This piece is performed by Master Aliasghar Bayani using a "Setar" instrument. Control group: The recruits in control group receive standard treatment and care. the standard care includes home rest, warm compression of the pain field, and 500 mg acetaminophen tablet intake (1-4 tabs per day in relation to the patient's pain). VAS (Visual Analogue Scale). Timepoint: At the beginning of the study, the tenth day and the thirtieth day. Method of measurement: Visual Analogue Scale questionnaire. Roland- Morris disability questionnaire score. Timepoint: At the beginning of the study, the tenth day and the thirtieth day. Method of measurement: Roland- Morris disability questionnaire. Speilberger State – Trait Anxiety Inventory score. Timepoint: At the beginning of the study, the tenth day and the thirtieth day. Method of measurement: Speilberger State – Trait Anxiety Inventory. Daily consumption of analgesic medication. Timepoint: At the beginning of the study, the tenth day and the thirtieth day. Method of measurement: Questionnaire. Salmannezhad Mizaj Identification Questionnaire score. Timepoint: At the beginning of the study. Method of measurement: Salmannezhad Mizaj Identification Questionnaire in Persian Medicine. Iran University of Medical Sciences Approved 2021-02-13 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)