The effect of intramuscular injection of calcitonin on the functional status of patients with osteoarthritis of the knee
Design
A controlled clinical trial with parallel groups, one-way blind, randomized, phase 3-2 was performed on 40 patients and a simple individual randomization method with sealed envelope tools was used.
Settings and conduct
This randomized controlled trial will be designed and implemented during August-November 2020 in the pain clinic of Imam Hossein (AS) Hospital (Tehran, Iran). The physician who evaluates patients at the beginning and two months later does not know the patient group (case group or control group).
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 35-75 years; knee pain during past 6 months; at least two clinical symptoms of joint inflammation based on ACR criteria for osteoarthritis (either clinical or clinical plus radiographic).
Exclusion criteria: unwilling to participate in the study; history of cardiovascular, renal, hepatic or gastrointestinal disease; history of coagulopathy; currently using DMOADS agents (hydroxychloroquine, sulfasalazine, methotrexate, cyclosporine, azathioprine); pre-existing allergies to calcitonin; history of intra-articular injection into the affected knee within 3 months before study enrollment; those having already received total knee arthroplasty; recent history of substance abuse and those who considered unable to reliably report outcome measures due to cognitive impairment.
Intervention groups
All patients are randomly divided into two groups: one group is injected calcitonin (50 IU/ml intramuscularly) once a week for 4 consecutive weeks, and in case of pain, AcetaGel (500mg) and piroxicam (0.5% topical gel)are prescribed, and the second group is given only conservative treatments including AcetaGel (500mg) and piroxicam are given.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130518013364N9
Registration date:2021-01-17, 1399/10/28
Registration timing:retrospective
Last update:2021-01-17, 1399/10/28
Update count:0
Registration date
2021-01-17, 1399/10/28
Registrant information
Name
Mehrdad Taheri
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 7840
Email address
m.taheri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
2020-07-26, 1399/05/05
Actual recruitment end date
2020-12-14, 1399/09/24
Trial completion date
2020-12-22, 1399/10/02
Scientific title
Efficacy of Intramuscular Injection of Calcitonin on Pain & Functional Status of Patients with Knee Osteoarthritis
Public title
Efficacy of Intramuscular Injection of Calcitonin on Pain & Functional Status of Patients with Knee Osteoarthritis
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 35-75 years
knee pain during past 6 months
At least two clinical symptoms of joint inflammation based on ACR criteria for osteoarthritis
Exclusion criteria:
unwillingness to participate in the study
History of cardiovascular disease
History of renal disease
History of hepatic disease
History of gastrointestinal disease
History of coagulopathy
History of intra-articular injection into the affected knee within 3 months before
Currently using DMOADS agents (hydroxychloroquine, sulfasalazine, methotrexate, cyclosporine, azathioprine)
Pre-existing allergies to calcitonin
Previous knee arthroplasty
Recent history of substance abuse
Those who cannot report the result reliably due to cognitive impairment
Age
From 35 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization is done with sealed envelope tools in such a way that the letters A and B are inserted in the envelopes and patients are asked to select an envelope that the intervention group A and the group B will be as control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The physician who evaluates patients two months later, does not know the patient's group( case or control group).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Abbas Arabi Street, Yemen Street, Shahid Chamran highway, Shahid Beheshti University Of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1617763141
Approval date
2020-07-12, 1399/04/22
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.362
Health conditions studied
1
Description of health condition studied
Osteoarthritis of knee
ICD-10 code
M17.0
ICD-10 code description
Bilateral primary osteoarthritis of knee
Primary outcomes
1
Description
pain
Timepoint
At the beginning of the study (before the intervention) and two months after
Method of measurement
VAS
2
Description
WOMAC Index
Timepoint
At the beginning of the study (before the intervention) and two months after
Method of measurement
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group is injected calcitonin (50 IU/ml intramuscularly) once a week for 4 consecutive weeks, and in case of pain, AcetaGel (500mg) and piroxicam (0.5% topical gel) are prescribed.
Category
Treatment - Other
2
Description
Control group: The control group is given maintenance treatments, including AcetaGel and piroxicam (0.5% topical gel).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospitalʼs pain clinic
Full name of responsible person
Mehrdad Taheri
Street address
Shahid Madani street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarqi
Street address
Shahid Abbas Arabi Street, Yemen Street, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Taheri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Madani street-Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Taheri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Madani street-Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Taheri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Madani street-Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available