Protocol summary
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Study aim
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Determining the therapeutic effects of Iranian "Nava" musical dastgah in the treatment of sciatica and comparing its efficacy with the common treatment
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Design
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Clinical trial with parallel control group, performed on 112 patients, outcome assessment is blind
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Settings and conduct
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This study is performed as a clinical trial on patients referred to the Neurosurgery Clinic of Hazrat Rasoul Akram Hospital and the Traditional Medicine Health Center affiliated to Iran University of Medical Sciences. In the intervention group, in addition to the usual treatment, patients listen to a five-minute piece of Iranian "Nava" musical dastgah once a day. And in the control group, patients receive only the usual treatment. The duration of this treatment period is ten days.
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Participants/Inclusion and exclusion criteria
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Diagnosis of sciatica (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; fluency in Persian.
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Intervention groups
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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 "Nava" 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).
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Main outcome variables
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(Visual Analogue Scale) VAS; Roland- Morris disability questionnaire score
General information
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Reason for update
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This study needs more time than the previous expected time frame due to the COVID_19 outbreaks.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210226050508N1
Registration date:
2021-05-31, 1400/03/10
Registration timing:
prospective
Last update:
2022-01-19, 1400/10/29
Update count:
1
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Registration date
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2021-05-31, 1400/03/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-06-22, 1400/04/01
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Expected recruitment end date
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2022-08-23, 1401/06/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Assessment of therapeutic effects of Iranian Nava musical dastgah on Sciatica and comparing it with the conventional medical treatment: a randomised control trial
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Public title
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Assessment of therapeutic effects of Iranian Nava musical dastgah on Sciatica and comparing it with the conventional medical treatment: a randomised control trial
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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From 35 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
112
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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This is the first clinical study dedicated specifically to the therapeutic effects of the Iranian Nava music Dastgah.
Ethics committees
1
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Ethics committee
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Approval date
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2021-02-13, 1399/11/25
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Ethics committee reference number
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IR.IUMS.REC.1399.1237
Health conditions studied
1
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Description of health condition studied
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Low back pain (Sciatica)
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ICD-10 code
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M54.30
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ICD-10 code description
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Sciatica, unspecified side
Primary outcomes
1
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Description
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VAS (Visual Analogue Scale)
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Timepoint
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At the beginning of the study, the tenth day and the thirtieth day
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Method of measurement
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Visual Analogue Scale questionnaire
2
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Description
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Roland- Morris disability questionnaire score
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Timepoint
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At the beginning of the study, the tenth day and the thirtieth day
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Method of measurement
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Roland- Morris disability questionnaire
Secondary outcomes
1
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Description
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Speilberger State – Trait Anxiety Inventory score
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Timepoint
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At the beginning of the study, the tenth day and the thirtieth day
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Method of measurement
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Speilberger State – Trait Anxiety Inventory
2
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Description
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Daily consumption of analgesic medication
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Timepoint
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At the beginning of the study, the tenth day and the thirtieth day
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Method of measurement
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Questionnaire
3
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Description
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Salmannezhad Mizaj Identification Questionnaire score
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Timepoint
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At the beginning of the study
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Method of measurement
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Salmannezhad Mizaj Identification Questionnaire in Persian Medicine
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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).
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available