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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General information
2022-02-20, 1400/12/01
2022-08-23, 1401/06/01
2022-0208-2023 00:00:00
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This study needs more time than the previous expected time frame due to the COVID_19 outbreaks.
This study needs more time than the previous expected time frame due to the COVID_19 outbreaks.
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به علت همه گیری بیماری کووید_19 بیمارگیری مدت زمان بیشتری نیازمند است و در بازه زمانی پیشبینی شده تکمیل نمی گردد.
به علت همه گیری بیماری کووید_19 بیمارگیری مدت زمان بیشتری نیازمند است و در بازه زمانی پیشبینی شده تکمیل نمی گردد.
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: مسعود سلیمانی
Full name of responsible person - Persian: masoud soleymani
Street address - English: Iran University of Medical Sciences Shahid Hemmat Highway
Street address - Persian: بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 8670 2504
Fax: +98 21 8862 2307
Email: research-m@iums.ac.ir
Web page address: https://vcr.iums.ac.ir/
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Masoud Soleymani
Full name of responsible person - Persian: مسعود سلیمانی
Street address - English: Iran University of Medical Sciences, Shahid Hemmat Highway
Street address - Persian: بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8670 2504
Fax: +98 21 8862 2307
Email: research-m@iums.ac.ir
Web page address: https://vcr.iums.ac.ir/
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: مسعود سلیمانیMasoud Soleymani Full name of responsible person - Persian: masoud soleymaniمسعود سلیمانی Street address - English: Iran University of Medical Sciences, Shahid Hemmat Highway Street address - Persian: بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران City - English: tehranTehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۹۶۱۴۵۳۵1449614535 Phone: +98 21 8670 2504 Fax: +98 21 8862 2307 Email: research-m@iums.ac.ir Web page address: https://vcr.iums.ac.ir/
Protocol summary
Study aim
Determining the therapeutic effects of Iranian "Nava" musical dastgah in the treatment of sciatica and comparing its efficacy with the common treatment
Design
Clinical trial with parallel control group, performed on 112 patients, outcome assessment is blind
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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).
This study needs more time than the previous expected time frame due to the COVID_19 outbreaks.
Acronym
IRCT registration information
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
Registration date
2021-05-31, 1400/03/10
Registrant information
Name
mona haghighi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 0356
Email address
dr.mona.haghighi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of therapeutic effects of Iranian Nava musical dastgah on Sciatica and comparing it with the conventional medical treatment: a randomised control trial
Public title
Assessment of therapeutic effects of Iranian Nava musical dastgah on Sciatica and comparing it with the conventional medical treatment: a randomised control trial
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
This is the first clinical study dedicated specifically to the therapeutic effects of the Iranian Nava music Dastgah.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-02-13, 1399/11/25
Ethics committee reference number
IR.IUMS.REC.1399.1237
Health conditions studied
1
Description of health condition studied
Low back pain (Sciatica)
ICD-10 code
M54.30
ICD-10 code description
Sciatica, unspecified side
Primary outcomes
1
Description
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
2
Description
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
Secondary outcomes
1
Description
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
2
Description
Daily consumption of analgesic medication
Timepoint
At the beginning of the study, the tenth day and the thirtieth day
Salmannezhad Mizaj Identification Questionnaire in Persian Medicine
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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).