Melatonin effect on pain and patient disability after percutaneous lumbar disc decompression
Design
If there was any response to medical treatment after 3 months they undergo percutaneous lumbar disc decompression.
Then the patients were randomly placed in two groups of control (C) and melatonin (M) by Random Allocation Software 2.0 using block randomization method in groups of 10.There are 35 patients in each group . The patients group did not register in the file. So, the Physician performing the procedure and whom following the patients did not know about the patients grouping.
Settings and conduct
ُُStudy was done in patients with lumbar disc herniation who refer to the Rasoul Akram Hospital pain clinic.Patients who didn't respond to drug after 3 months the undergo PLDD and then randomly were devided in two groups by random allocation software and take their own drug inorde to the group belongs to.
Participants/Inclusion and exclusion criteria
Patients with lumbar radicular moderate to high pain,lumbar disc herniation in 1 to 3 lumbar levels based on MRI and physical examination ,that no respond to 3 months conservative treatment inserted to the study.
Intervention groups
After percutaneous laser disk decompression Patients randomly were divided into 2 groups.
Both of the groups receive pregabalin, diclofenac and vitamin B1 daily for 3 months orally but control group received melatonin3 mg for 3 months in addition.
Oral melatonin Effect on pain after percutaneous lumbar disc decompression
Public title
Oral melatonin effect on pain after percutaneous lumbar disc decompression: a double-blind randomized clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral or bilateral chronic radicular low back pain.
Moderate to high pain score (VAS 3 or higher).
Confirmation of LDH in one to three lumbar levels based on MRI and physical examination findings.
ASA class I-II.
No respond to conservative treatments (at least for three months)
Exclusion criteria:
Include disc extrusion or sequestration.
Disc height reduction of more than 50%.
Severe spinal deformity.
Tumor or spinal fracture or spondylolisthesis.
Local or systemic infection.
Use of anticoagulants.
History of allergic reaction to study drugs.
Pregnancy and breastfeeding.
Severe disorders.
Sudden onset of neurological deficit such as urinary and fecal incontinence.
History of lumbar spine surgery.
Peripheral neuropathy.
Patient refusal.
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
It was done as Random Allocation Block by (Random Allocation Software 2.0) in groups of 10 people.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients qrouping will not record in the file, so the physition who perform the procedure and whom examine in the clinic will not aware of the patients qrouping also they are not involve in the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran university of ethics committee
Street address
Rasool acam pain research center,4th step,department no 2.shr arar street,.
City
tehran
Province
Tehran
Postal code
1445613131
Approval date
2023-05-28, 1402/03/07
Ethics committee reference number
IR.IUMS.REC.1402.176
Health conditions studied
1
Description of health condition studied
Oral Melatonin effect on pain and disability after percutaneous disc decompression
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Determining the effect of oral melatonin on patients pain relief after lumbar disc decompression by SLR physical examination degree in intervention and control groups that will done by pain fellowship in pain clinic in specific time.
Timepoint
0,2 week,2nd month.3rd month
Method of measurement
Physical examination and determination SLR degree by pain fellowship in specific time.
2
Description
Determining the effect of oral melatonin on patients pain relief by ( Oswestry Disability Index) using questionnaire that complete by pain fellowship.
Timepoint
0,2 week,2nd month.3rd month
Method of measurement
Determination of McGill pain index using questionnaire that complete by pain fellowship.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients in trial group, will take 3 mg melatonin tablets in addition to drugs belong to control group. The drugs will register electronically and Medicines are prepared from the Rasool Aakram Hospital pharmacy. The patient does not pay the cost of the melatonin drug and the cost is paid to the pharmacy by researcher separatly . In this way, the drug producing company is same in all patients.
Category
Treatment - Drugs
2
Description
Control group:After PLDD patients will receive Diclofenac,pregsbaline and vitamin B1by electronic prescription.Drugs will be taken from Rasool Aakram Hospital pharmacy and drugs brand and company are the same in all patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool acram hospital
Full name of responsible person
Seyyedeh Fatemeh Morsali
Street address
4th floor,department no 2,pain research center of Rasool acram hospital,Shahr ara street
City
tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Email
fatemehmorssali@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Morsali
Street address
Iran University if medical science, Next to Milad Tower, Hemet Highway, Tehran
City
tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Email
fatemehmorssali@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
20
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Morsal
Position
fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Rasool Acram Pain Research Center Niayesh street,Sattarkhan ave,tehan
City
tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Email
fatemehmorssali@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Morsali
Position
pain fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Pain Research center of Rasool Acram hospital,Niayesh street,Sattar khan ave,Tehran city
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Email
fatemehmorssali@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
seyyedeh fatemehmorsali
Position
pain felloewship
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Rasool acram Pain Research Center,4th step,building no 2,Rasool acram hospital,shahr ara street,sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Fax
Email
fatemehmorssali@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Participants data can be shared
When the data will become available and for how long
starting one year after complete of study
To whom data/document is available
ِData will be shared for academic institutions.
Under which criteria data/document could be used
The reason of needding data must be determine with detail.
From where data/document is obtainable
fatemehmorssali@yahoo.com
What processes are involved for a request to access data/document
Up to one month after request they can receive data.