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Evaluation of response to calcitonin treatment in patients with frozen shoulder in selected hospitals of Islamic Azad University of Medical Sciences, Tehran in 2022

Protocol summary

Study aim
Determination of response to treatment with calcitonin in patients with frozen shoulder
Design
This research has two groups of common treatment and combined treatment, which is based on the random selection of samples based on the inclusion criteria and is done by lottery. The sample size of the study is 64 people and the clinical trial phase.
Settings and conduct
The samples are divided into two separate groups, the common treatment group receives current common treatments, but the combined treatment group receives intranasal calcitonin spray of 200 units in addition to common treatments, the results are compared, the place of study Orthopedic clinic is a selected hospital of Tehran Islamic Azad University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with a clinical diagnosis of frozen shoulder based on symptoms including limitation in all active and passive movements of the shoulder joint in all directions along with relatively severe pain, reduced range of motion of the shoulder and definitive confirmation of the diagnosis with the help of MRI of the shoulder joint Conditions of non-entry: The patient's shoulder pain is accompanied by other causes other than the diagnosis of frozen shoulder, such as strain, dislocation, separation, tendonitis, bursitis, rotator cuff tendon rupture, fracture, etc.
Intervention groups
Common treatment group: Aspirin administration, non-steroidal anti-inflammatory drugs, intra-articular injection of steroid and physiotherapy. Combined treatment group: 200 units intranasal calcitonin spray is prescribed along with the common treatment.
Main outcome variables
Improvement of pain and range of motion in patients with frozen shoulder after receiving intranasal calcitonin spray

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220523054971N1
Registration date: 2023-04-03, 1402/01/14
Registration timing: registered_while_recruiting

Last update: 2023-04-03, 1402/01/14
Update count: 0
Registration date
2023-04-03, 1402/01/14
Registrant information
Name
Pedram Nourmandipoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2219 4993
Email address
pedramnourmandipoor7536@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-19, 1400/09/28
Expected recruitment end date
2023-08-22, 1402/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of response to calcitonin treatment in patients with frozen shoulder in selected hospitals of Islamic Azad University of Medical Sciences, Tehran in 2022
Public title
Effect of calcitonin in frozen shoulder treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a clinical diagnosis of frozen shoulder Patients symptoms including limitation in all active and passive movements of the shoulder joint in all directions Patients with relatively severe pain Patients with reduction in the range of motion of the shoulder Definite confirmation of the diagnosis with the help of MRI of the shoulder joint
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is based on a simple random sampling method and based on lottery, cards are prepared according to the sample volume and the desired number is recorded on each card, the cards are placed in a box, then the cards are mixed, and they get out of the box by accident and one after the other until the capacity of both groups is completed.
Blinding (investigator's opinion)
Single blinded
Blinding description
After determining the samples of the combined treatment group and obtaining informed consent from them, calcitonin nasal spray is added to the common treatment of this group of patients.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran Islamic Azad University of Medical Sciences
Street address
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St., Aineh Blvd., Amir Pabarja St., Gholhak Blvd., Doctor Shariati Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2022-05-16, 1401/02/26
Ethics committee reference number
IR.IAU.TMU.REC.1401.012

Health conditions studied

1

Description of health condition studied
Frozen shoulder
ICD-10 code
M75.00
ICD-10 code description
Adhesive capsulitis of unspecified shoulder

Primary outcomes

1

Description
Pain changes with visual analogue scale(VAS)
Timepoint
6 weeks after receiving calcitonin nasal spray
Method of measurement
Visual analogue scale

2

Description
Changes in the range of motion with the angle scale in degrees
Timepoint
6 weeks after receiving calcitonin nasal spray
Method of measurement
Degrees of angle

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients receiving calcitonin nasal spray in addition to common treatments; In this group of patients, intranasal calcitonin spray of 200 units is prescribed along with current common treatments such as aspirin, ibuprofen, intra-articular injection of steroids and physical therapy; the effect of this treatment method is checked from the time of administration to 6 weeks later in the form of face-to-face interview or phone call and compared with the results of the control group.
Category
Treatment - Drugs

2

Description
Control group: Patients receiving common treatments; This group of patients receives current common treatments such as aspirin, ibuprofen, intra-articular injection of steroids and physiotherapy, and the results of the intervention group are compared with the results of this group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin Javadieh Hospital
Full name of responsible person
Dr Naser Rahbar
Street address
In front of Sardar jangal Park, Shirmohammadi St., Naziabad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6550
Fax
+98 21 5534 6301
Email
amhos@iautmu.ac.ir
Web page address
https://tms.iau.ir

2

Recruitment center
Name of recruitment center
Bu Ali Hospital
Full name of responsible person
Dr Alireza Teimouri
Street address
At the beginning of Damavand St., Imam Hossein Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
17117
Phone
+98 21 3334 8036
Fax
+98 21 3378 6182
Email
booali.hospital96@gmail.com
Web page address
https://tms.iau.ir/bouali

3

Recruitment center
Name of recruitment center
Farhikhtegan Hospital
Full name of responsible person
Dr Hamidreza Gholamrezaiee
Street address
In front of the Central Organization Islamic Azad University, University Sq., The End of Sattari North Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4486 7262
Fax
+98 21 4484 5171
Email
farhikhteganhospital@gmail.com
Web page address
https://tms.iau.ir/farhikhtegan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Masoud Parsania
Street address
Tehran Islamic Azad University Of Medical Sciences, Danesh Dead-end., Attari Moghaddam St., Shahid Khaghani St., Shariati St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Fax
+98 21 2200 8049
Email
iau-tmuj@yahoo.com
Web page address
https://tms.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Dr Afshin Farhadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Amiralmomenin Hospital, In front of Sardar Jangal Park, Shirmohammadi St., Naziabad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6550
Email
afshinfarhadi53@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Afshin Farhadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Amiralmomenin hospital, In front of Sardar Jangal Park, Shirmohammadi St., Naziabad., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6550
Email
afshinfarhadi53@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Afshin Farhadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Amiralmomenin Hospital, In front of Sardar Jangal Park, Shirmohammadi St., Naziabad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6550
Email
afshinfarhadi53@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
Yes - There is 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
All data can be shared after de-identifying study participants.
When the data will become available and for how long
Access to the data starts 6 months after the publication of the thesis.
To whom data/document is available
General doctors and orthopedic specialists
Under which criteria data/document could be used
The data can be used for further research to achieve the definite effect of the treatment method, to access the data, you should talk to the scientific officer of the research.
From where data/document is obtainable
Visit in person to Dr. Afshin farhadi at the address of Tehran, Naziabad, Shirmohammadi St., In front of Sardar Jangal Park, Amiralmomenin Javadieh Hospital, Building No. 3, Orthopedic Clinic
What processes are involved for a request to access data/document
Visit in person to obtain permission from the scientific research officer
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