Determining efficacy of melatonin, and zolpidem on the sleep quality, and severity of pain in the patients with chronic non-specific low back pain
Design
In this research, 46 eligible patients with low back pain referring to Mahdieh Clinic in Kermanshah were chosen purposefully and were refereed to Sleep Research Center and their pain was assessed and their sleep status were mentally and objectively assessed and they were randomly allocated in one of three groups of receiving:1-melatonin, 2-zolpidem, and 3-placebo. After one month of physiotherapy treatment their pain and sleep quality were reassessed.
Settings and conduct
Physiotherapy treatment was done in Mahdieh Clinic in Kermanshah and pain and sleep status was assessed in Sleep Research Center of Kermanshah medical university.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Having nonspecific low back pain, Age of 30-65 y, having insomnia.
Exclusion Criteria:
Having other sleep problems, having other musculoskletal disorders.
Sleep quality based on Pittsburgh questionnaire.
Sleep quality based on Actigraphy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111109008035N4
Registration date:2017-12-29, 1396/10/08
Registration timing:registered_while_recruiting
Last update:2017-12-29, 1396/10/08
Update count:0
Registration date
2017-12-29, 1396/10/08
Registrant information
Name
MohammadBagher Shamsi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3838 4185
Email address
mshamsi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of efficacy of melatonin, and zolpidem on the sleep quality, and severity of pain in the patients with chronic non-specific low back pain
Public title
The study of efficacy of melatonin, and zolpidem on the sleep quality, and severity of pain in the patients with chronic non-specific low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with non-specific low back pain who complain of insomnia and poor quality of sleep for more than 1 month.
Exclusion criteria:
Herniated lumbar discopathy; malignancy; sleep apnea; psychosis; drug abuse; past history of other sleep disorders and medical problems affecting sleep quality such as diabetes mellitus & chronic renal failure.
Age
From 30 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Table of random numbers will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants are blind. The psychologist who will do assessment of pain intensity and also sleep quality mentally (by questionnaire) and objective (by actigraph) and the physiotherapist who will physically treat the participants are blind too.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences,
Street address
Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2017-09-27, 1396/07/05
Ethics committee reference number
IR.KUMS.ERC.1396.348
Health conditions studied
1
Description of health condition studied
Low Back Pain
ICD-10 code
M54.9
ICD-10 code description
Dorsalgia, unspecified
Primary outcomes
1
Description
Sleep quality
Timepoint
At the start and end of the study
Method of measurement
Pittsburgh questionnaire and Actigraphy
Secondary outcomes
1
Description
Visual Analogue Scale
Timepoint
At the start and end of the study
Method of measurement
Visual Analogue Scale
2
Description
Disability
Timepoint
At the start and end of the study
Method of measurement
With Oswestry disability index
Intervention groups
1
Description
Melatonin or N-acetyl-5-methoxy tryptamine 3 milligrams per night for one month (during 20 physiotherapy sessions on alternate days)
Category
Treatment - Drugs
2
Description
Zolpidem or Ambien 5 milligrams per day for one month (during 20 physiotherapy sessions on alternate days)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Outpatient Clinic of Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Bagher Shamsi
Street address
Javanshir Street
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3827 9697
Email
mbshamsi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farid Najafi
Street address
Shahid beheshti Boulevard,
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3827 9697
Email
mbshamsi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
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
Kermanshah University of Medical Sciences
Full name of responsible person
MohammadBagher Shamsi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Kermanshah University of Medical Sciences, Shahid Behshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3724 1929
Fax
Email
mbshamsi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences,
Full name of responsible person
MohammadBagher Shamsi
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Kermanshah University of Medical Sciences, Shahid Behshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3724 1929
Fax
Email
mbshamsi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
MohammadBagher Shamsi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Kermanshah University of Medical Sciences, Shahid Behshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 1724 1929
Fax
Email
mbshamsi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All collected deidentified data will be shared with others.
When the data will become available and for how long
Starting 6 months after relative manuscript publication.
To whom data/document is available
Researchers working in academic institutions or people working in businesses can also apply to receive it.
Under which criteria data/document could be used
No access criteria for data/documents.
From where data/document is obtainable
Correspond with Dr MohammadBagher Shamsi.
What processes are involved for a request to access data/document
Correspond with and email to Dr MohammadBagher Shamsi.