The effect of vitamin D on the control of chronic Musculoskeletal pain.
Design
Patients will be divided into two groups of 40 individuals in pairs, without randomization or blinding. The first group will receive 500 mg of naproxen daily in a single dose and the second group will receive a 300,000 unit intramuscular injection of naproxen every two weeks. Patients will be evaluated after 10 weeks and their pain levels will be measured by the NRS questionnaire.
Settings and conduct
A study will be conducted to determine the effect of vitamin D on chronic musculoskeletal pain in Fatemi Hospital of Ardabil.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients included in the study have chronic muscle pain and vitamin D levels are less than 30 ng / dl and are indicated for naproxen intake.
Exclusion criteria: Having underlying disease such as diabetes, cancer, rheumatoid arthritis
Intervention groups
Patients will be randomly divided into two groups of 40 each.The first group will receive 500 mg of naproxen daily in a single dose and the second group will receive a 300,000 unit intramuscular injection of naproxen every two weeks.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191019045153N1
Registration date:2019-12-07, 1398/09/16
Registration timing:retrospective
Last update:2019-12-07, 1398/09/16
Update count:0
Registration date
2019-12-07, 1398/09/16
Registrant information
Name
Aydin Arabzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3323 0739
Email address
z.pouaziz@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Vitamin D on the Treatment of Patients with Chronic Musculoskeletal Pain with Serum Vitamin D Deficiency
Public title
The Effect of Vitamin D on the Treatment of Patients with Chronic Musculoskeletal Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 15 to 45years
History of Chronic Pain Musculoskeletal Pain
Low level of vitamin D, less than 30 n / ml
Exclusion criteria:
Having underlying diseases like diabetes, cancer, rheumatologic disease
Age
From 15 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
No. 1, Daneshgah Ave
City
Ardabil
Province
Ardabil
Postal code
5613843791
Approval date
2019-10-26, 1398/08/04
Ethics committee reference number
IR.ARUMS.REC.1398.401
Health conditions studied
1
Description of health condition studied
Musculoskeletal Pain
ICD-10 code
M79.6
ICD-10 code description
Pain in limb, hand, foot, fingers and toes
Primary outcomes
1
Description
Pain
Timepoint
At baseline and then 10 weeks after treatment
Method of measurement
NRS (numerical rating scale) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: This group includes 40 patients with chronic musculoskeletal pain who have vitamin D levels less than 30 ng / ml. These patients will receive 500 mg of oral naproxen daily. The pill will be a single daily dose of Tehran medicine.
Category
Treatment - Drugs
2
Description
Intervention group2: This group includes 40 patients with chronic musculoskeletapain who have vitamin D levels less than 30 ng / ml. These patients will receive 500 mg oral naproxen daily and a 300,000 unit dose of vitamin D every two weeks. The tablets will be supplied in a single daily dose and manufactured by Caspian Company's Vitamin D and Ampoule Vitamin D tablets and will be given by injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemi hospital
Full name of responsible person
Zahra Pouraziz
Street address
No. 1, Emam Khomeyni Ave
City
Ardabil
Province
Ardabil
Postal code
5613843792
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Parvaneh Naftchi
Street address
No. 1, Daneshgah Ave
City
Ardabil
Province
Ardabil
Postal code
5613874587
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Aydin Arabzadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No. 1, Emam Khomeyni Ave
City
Ardabil
Province
Ardabil
Postal code
5613843793
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Aydin Arabzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No. 1, Emam Khomeyni Ave
City
Ardabil
Province
Ardabil
Postal code
56138791
Phone
009845230739
Email
meisamfooladi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Aydin Arabzadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No. 1, Emam Khomeyni Ave
City
Ardabil
Province
Ardabil
Postal code
5613843791
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.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
Undecided - It is not yet known if there will be 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
The questionnaires will be made available anonymously and with a file number.
When the data will become available and for how long
پس از اتمام مطالعه
To whom data/document is available
University professors
Under which criteria data/document could be used
In order to find out how to work in SPSS file, anonymous questionnaires will only be available with file number.
From where data/document is obtainable
Contact Dr. Aydin Arabzadeh.
What processes are involved for a request to access data/document
Information is available after contacting Dr. Vahid Adiban and University approval.