Purpose: Studying effects of ostrich oil on musculoskeletal pain comparing with the placebo effect. Method: 60 patients with musculoskeletal pain without history of operation and injection will be included in this study. In case of dissent or requirement of operation or splint, they will be excluded. Using Excel software, we divided the numbers 1-60 into two groups randomly. The numbers will be allocated to drug (Ostrich oil) and placebo (Olive oil) groups.
Random packets containing the prescriptions will be provided. Sealed packets will be given to patients randomly whereas the inside information is not visible and patients and the physician won’t be aware of the grouping. Ostrich oil and olive oil will be previously kept in hospital’s drug store and patients will receive the oil by going to the drugstore. Patients’ names and their specific codes will be recorded in a log. Each patient will receive a packet and a brochure containing the instruction. Patients will be asked to spray the topical medication on the skin twice per day and massage it for 5 minutes.
Follow-up visits will be after 1 week (5-10 days), 2 weeks (10-16 days) and a month (4-6 weeks) and related questionnaires will be completed by an examiner who also won’t be aware of the groups. The outcomes such as amount of pain, symptom improvement time, area of pain, and quality of life will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122831631N1
Registration date:2017-08-17, 1396/05/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-17, 1396/05/26
Registrant information
Name
Amir Reza Kachooei
Name of organization / entity
Orthopedic research center, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 7453
Email address
kachoeear@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Prolife compony
Expected recruitment start date
2017-07-15, 1396/04/24
Expected recruitment end date
2018-12-30, 1397/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical trial to compare the effect of ostrich oil versus placebo on pain in patients with muscluskeletal disorders
Public title
The effect of ostrich oil on musculoskeletal disorders' pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being an adult and having musculoskeletal pain; Having no medical history of injection, surgery and topical medicine on the area.
Exclusion criteria:
No willingness for participation;
Requiring to use brace or cast;
Having other conditions such as CTS;
Requiring physical therapy;
Having history of surgery on the area .
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Using Excel software, we divided the numbers 1-60 into two groups randomly. The numbers were allocated to drug and placebo groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics committee of Vice Chancellor of Research Mashhad University of Medical Sciences
Street address
Centeral building of Mashhad University of Medical Sciences(Ghoreishii), Daneshgah St, Mashhad, Khorasan Razavii, Iran
City
Mashhad
Postal code
Approval date
2017-05-20, 1396/02/30
Ethics committee reference number
IR.MUMS.REC.1396.36
Health conditions studied
1
Description of health condition studied
Musculoskeletal pain
ICD-10 code
M79.1
ICD-10 code description
Myalgia
Primary outcomes
1
Description
Pain intensity
Timepoint
Before intervention, and 1 week(5-10 days), 2 weeks(10-16 days), one month(4-6 weeks) after intervention
Method of measurement
VAS and McGill questionnaire
Secondary outcomes
1
Description
Symptoms improvement time
Timepoint
At the begining and at the end of the trial
Method of measurement
VAS and McGill questionnaire
2
Description
Area of pain
Timepoint
Before and after the intervention
Method of measurement
using the "area of pain" diagram and software for calculating the area
3
Description
Quality of Life
Timepoint
Before and after intervention
Method of measurement
WHOQOL questionnaire
Intervention groups
1
Description
Intervention group:
Each patient will receive a packet and a brochure containing the instructions. Patients will be asked to spray the topical medication(ostrich oil) on the skin twice per day and massage the area for 5 minutes.
The oil is provided by Prolife Company.
Category
Treatment - Drugs
2
Description
Control group:
Each patient will receive a packet and a brochure containing the instruction. Patients will be asked to spray the topical medication(olive oil) on the skin twice per day and massage it for 5 minutes.
The oil is provided by Prolife Company.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital clinic
Full name of responsible person
Ali Talebi
Street address
Parastar St, Ahmadabad Blvd
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Prolife Company
Full name of responsible person
Mr Shirzad
Street address
20th avenue, Valiasr St
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Prolife Company
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Vice Chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Ghoreishi Building, Daneshgah St
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Mashhad University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Orthopedic research center
Full name of responsible person
Niloufar Alavi
Position
Bimedical Engineer
Other areas of specialty/work
Street address
Orthopedic Research Center, Ghaem Hospital, Ahmadabad Blvd
City
Mashhad
Postal code
9176699199
Phone
+98 51 3841 7453
Fax
+98 51 3841 7453
Email
alavi.niloofar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir Reza Kachooei
Position
Fellowship Trained Orthopaedic Hand and Elbow Surgeon, Assistant Professor, Mashhad University Of Me
Other areas of specialty/work
Street address
Orthopedic Research center, Ghaem Hospital, AhmadAbad BLVD
City
Mshhad
Postal code
9176699199
Phone
+98 51 3841 7453
Fax
+98 51 3841 7453
Email
KachoeeAR@mums.ac.ir;arkachooei@gmail.com
Web page address
http://kachooei.com
Person responsible for updating data
Contact
Name of organization / entity
Orthopedic Research Center
Full name of responsible person
Niloufar Alavi
Position
Biomedical engineer, Bachelor degree
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmadabad Blvd
City
Mashhad
Postal code
9176699199
Phone
+98 51 3841 7453
Fax
+98 51 3841 7453
Email
alavi.niloofar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)