This study is conducted to evaluate the effect of nasal calcitonin on pain and range of motion improvement in patients with shoulder adhesive capsulitis.
Design
A randomized, blinded clinical trial with two parallel groups of 100 patients.
Settings and conduct
This study is done in Kashani hospital , Isfahan, iran.
Participants/Inclusion and exclusion criteria
Inclusion criterion:
۱. Patients diagnosed with adhesive capsulitis( Diagnostic criterion: 1. Shoulder pain and stiffness for at least 4 weeks 2.Severe shoulder pain that restricts daily activities 3. Nocturnal pain 4. Limitation in active and passive range of motion
۲. Patients in first stage of disease( Progressive pain and limitation in range of motion from past 3 months)
۳. Patient agreement to enter the trial
۴. 30 to 60 years old patients
Exclusion criterion:
1. Patients with history of trauma, surgery, corticosteroid injection or any previous injury to the shoulder.
2. Patients who had received other treatments including surgical or nonsurgical treatments prior to entering the trial.
Intervention groups
Intervention group: This group receives nasal calcitonin spray. It should be used with dosage of one puff daily for 8 weeks.
Control group: This group does not receive calcitonin spray
Main outcome variables
Pain ; Range of motion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210223050470N1
Registration date:2021-05-22, 1400/03/01
Registration timing:prospective
Last update:2021-05-22, 1400/03/01
Update count:0
Registration date
2021-05-22, 1400/03/01
Registrant information
Name
Shakiba Dehghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 8644
Email address
shakibadehghanii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Calcitonin effects on shoulder adhesive capsulitis
Public title
Calcitonin in shoulder adhesive capsulitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with adhesive capsulitis (Diagnostic criterion: 1. Shoulder pain and stiffness for at least 4 weeks 2. Severe shoulder pain that restricts daily activities 3. Nocturnal pain 4. Limitation in active and passive range of motion
Patients in first stage of disease( Progressive pain and limitation in range of motion from past 3 months.)
Patient agreement to enter the trial
30 to 60 years old patients
Exclusion criteria:
Patients with history of trauma, surgery, corticosteroid injection or any previous injury to the shoulder
Patients who had received other treatments including surgical or nonsurgical treatments prior to entering the trial
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Using statistical software, a set of numbers is generated and formed in the form of random permutation blocks with a volume of 4. The two smaller numbers in each block are for patients receiving calcitonin, and the two larger numbers are for patients not receiving calcitonin. Each patient is assigned a number according to the order of enrollment, and depending on whether the number assigned to the patient in the permutation block of 4 is among the large numbers or small numbers, the patient is either in the spray receiving group or the group who do not receive spray.
Blinding (investigator's opinion)
Single blinded
Blinding description
Principal Investigator who initially examines the patients to assess inclusion and exclusion criterion and determines the eligible patients to enter the intervention and visits them in the follow-up process, is unaware of which group the patients are in. Another person divides patients into two groups according to the aforementioned randomization method, the group receiving the spray and the group who do not not receive the spray. The data analyzer is also unaware of which group the patients belonged to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan university of medical science
Street address
No 38, 2nd alley, Mollasadra St.
City
Isfahan
Province
Isfehan
Postal code
8168613441
Approval date
2021-03-19, 1399/12/29
Ethics committee reference number
IR.MUI.MED.REC.1399.1181
Health conditions studied
1
Description of health condition studied
adhesive capsulitis of shoulder
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder
Primary outcomes
1
Description
Pain severity
Timepoint
Before starting the intervention, 2 months and 6 months after starting the intervention
Method of measurement
By Visual Analogue Scale( VAS )
2
Description
Shoulder range of motion
Timepoint
Before starting the intervention, 2 months and 6 months after starting the intervention
Method of measurement
By physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: this group receives nasal calcitonin spray. It should be used with dosage of one puff daily for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: this group does not receive calcitonin spray.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Mohammad Dehghani
Street address
Kashani St.
City
Isfahan
Province
Isfehan
Postal code
8168613441
Phone
+98 31 3233 0091
Email
shakibadehghanii@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vice President for Research and Technology of isfahan university of medical science
Street address
Isfahan university of medical science , hezarjarib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Email
shakibadehghanii@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Dehghani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
No 38, 2nd alley, Mollasadra St.
City
Esfahan
Province
Isfehan
Postal code
8168613441
Phone
0098316688644
Email
shakibadehghanii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Dehghani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
No 38, 2nd alley, Mollasadra St.
City
Isfahan
Province
Isfehan
Postal code
8168613441
Phone
0098316688644
Email
m_dehghani@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shakiba Dehghani
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
No. 38, 2nd alley, Mollasadra street
City
Isfahan
Province
Isfehan
Postal code
8168613441
Phone
+98 31 3668 8644
Fax
Email
shakibadehghanii@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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data is encrypted in order to make the identities of individuals unidentifiable and confidential
When the data will become available and for how long
after
To whom data/document is available
University Ethics Committee, Project Arbitration Committee, Article Arbitration Committee and other researchers
Under which criteria data/document could be used
ystematic review or meta-analysis by mentioning the document
From where data/document is obtainable
Dr. mohammad dehghani
What processes are involved for a request to access data/document
After submitting the application via academic email, we will provide the information files to the individuals within a maximum of one month.