The aim of this study is to evaluate the effect of Calcitonin on shoulder adhesive capsulitis. In a randomized triple blinded clinical trial, 72 patients with shoulder adhesive capsulitis referring to orthopedic clinic of Shohada Hospital, Tabriz, Iran, will be randomly divided into two groups. The key inclusion criteria are to have shoulder adhesive capsulitis and not to receive any kind of systemic corticosteroid. Exclusion criteria will include occurrence of any intolerable adverse effect. Calcitonin 200 units/mg nasal spray made by Sina Darou Corporation will be administered for intervention group one puff daily for six weeks while patients in control group will receive placebo with the same shape and size of the original drug made by the same manufacturer for the same period. All the individuals will be assessed for the severity of pain, joint range of motion and SPADI, DASH and HAQ scoring before and 3, 6 and 12 weeks after the initiation of the treatment. Then the gathered data will be compared within and between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013080414271N1
Registration date:2013-08-25, 1392/06/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-25, 1392/06/03
Registrant information
Name
Alireza Rouhani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1658 4305
Email address
rouhania@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Calcitonin effects on shoulder Adhesive capsulitis
Public title
Calcitonin in treatment of shoulder capsulitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (To have shoulder adhesive capsulitis; not to have history of surgery or any prior trauma to the shoulder; not to have a systemic disease like diabetes or hypo or hyperthyroidism; not to receive any kind of systemic corticosteroid)
Exclusion criteria: (Occurrence of intolerable adverse effects)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Sq.
City
Tabriz
Postal code
Approval date
2013-04-21, 1392/02/01
Ethics committee reference number
9228
Health conditions studied
1
Description of health condition studied
Shoulder adhesive capsulitis
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder
Primary outcomes
1
Description
Pain severity
Timepoint
Before the initiation of the treatment and 3, 6 and 12 weeks after the initiation of the treatment.
Method of measurement
Using Visual Analog Scale
2
Description
Shoulder range of motion
Timepoint
Before the initiation of the treatment and 3, 6 and 12 weeks after the initiation of the treatment.
Method of measurement
Using physical examination
3
Description
DASH score
Timepoint
Before the initiation of the treatment and 3, 6 and 12 weeks after the initiation of the treatment.
Method of measurement
Using DASH questionnaire
4
Description
SPADI score
Timepoint
Before the initiation of the treatment and 3, 6 and 12 weeks after the initiation of the treatment.
Method of measurement
Using SPADI questionnaire
5
Description
HAQ score
Timepoint
Before the initiation of the treatment and 3, 6 and 12 weeks after the initiation of the treatment.
Method of measurement
Using HAQ questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
For intervention group: Calcitonin 200 units/mg nasal spray made by Sina Darou Corporation will be administered for six weeks.
Category
Treatment - Drugs
2
Description
For control group: Placebo nasal spray with the same shape and size of the Calcitonin nasal spray made by Sina Darou one puff daily for sex weeks will be administered.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Shohada Hospital
Full name of responsible person
Alireza Rouhani
Street address
Shohada Hospital, Parvaz st.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
AliReza Ostad Rahimi
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah Avenue, Daneshgah Square
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mahmoud Barzgar
Position
Resident of orthopedics
Other areas of specialty/work
Street address
Shohada Hospital, Parvaz st.
City
Tabriz
Postal code
Phone
+98 41 1335 7310
Fax
Email
Mahmud.barzgar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Rouhani
Position
Orthopedist/Associate professor
Other areas of specialty/work
Street address
Shohada Hospital, Parvaz st.
City
Tabriz
Postal code
Phone
+98 41 1335 7310
Fax
Email
rouhania@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Hemmati
Position
General physician
Other areas of specialty/work
Street address
Emam Reza Hospital, Daneshgah Ave.
City
Tabriz
Postal code
Phone
+98 41 1658 4305
Fax
Email
mehdi.hemmati@rocketmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)