Comparison of the pain-relief effect of herbal ointment versus piroxicam gel in patients with musculoskeletal pain: a triple blind randomized clinical trial
Objectives: To compare the pain-relief effect of herbal ointment versus piroxicam gel in patients with musculoskeletal pain.
Design: A triple blind randomized clinical trial.
Setting and conduct: The eligible patients with musculoskeletal pain who will refer to Shahid Mobasher Kashani Clinic during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 70 years; musculoskeletal pain.
Exclusion criteria: Pregnancy and breastfeeding; cutaneous disease; sensitivity of herbal compound.
Intervention group: Topical using herbal ointment twice a day for one week.
Control group: Topical using piroxicam gel twice a day for one week.
Primary outcome: Severity of the pain using visual analog scale (VAS) before intervention and one and three weeks after treatment.
Secondary outcome: Morning stiffness through taking history before intervention and one and three weeks after treatment
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201708029014N177
Registration date:2017-08-05, 1396/05/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-05, 1396/05/14
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the pain-relief effect of herbal ointment versus piroxicam gel in patients with musculoskeletal pain: a triple blind randomized clinical trial
Public title
Comparison of the pain-relief effect of herbal ointment versus piroxicam gel in patients with musculoskeletal pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 70 years; musculoskeletal pain.
Exclusion criteria: Pregnancy and breastfeeding; cutaneous disease; sensitivity of herbal compound.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Approval date
2017-07-29, 1396/05/07
Ethics committee reference number
IR.UMSHA.REC.1396.345
Health conditions studied
1
Description of health condition studied
Musculoskeletal pain
ICD-10 code
M95
ICD-10 code description
Other acquired deformities of musculoskeletal system and connective tissue
Primary outcomes
1
Description
Severity of the pain
Timepoint
before intervention and one and three weeks after treatment
Method of measurement
using visual analog scale (VAS)
Secondary outcomes
1
Description
Morning stiffness
Timepoint
before intervention and one and three weeks after treatment
Method of measurement
through taking history
Intervention groups
1
Description
Intervention group: Topical using herbal ointment twice a day for one week.
Category
Treatment - Drugs
2
Description
Control group: Topical using piroxicam gel twice a day for one week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mobasher Kashani Clinic
Full name of responsible person
Dr Bijan Heidari
Street address
Shahid Mobasher Kashani Clinic, Mahdieh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 and Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
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
School of Pharmacy
Full name of responsible person
Dr Dara Dastan
Position
Pharmacologist
Other areas of specialty/work
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
d.dastan@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Mobasher Kashani Clinic
Full name of responsible person
Dr Bijan Heidari
Position
Orthopedist
Other areas of specialty/work
Street address
Shahid Mobasher Kashani Clinic, Mahdieh Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
dr.bijanheidari80@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)