Comparing the effect of home based exercise and routine physiotherapy on pain and function in patients with adhesive capsulitis of shoulder:a randomized clinical trial
The aim of this study is to compare home based exercise to physiotherapy treatment on pain and function of patients with adhesive capsulitis. In this single blind (assessor blinding), phase 3, clinical randomized trial 50 patients (from Firouzgar university hospital, Tehran) suffering from frozen shoulder for more than 3 month, aged between 30 and 65 year and without any systemic disease will be randomly divided into two groups using sealed envelopes. The first group will receive routine physiotherapy treatment including 10 sessions of physical modality and specific stretching and strengthening exercises, while the second group will only be thought the same specific exercises and will be advised to perform them at home and stay as much active as they can. Pain (using visual analogue scale) and function (using oxford shoulder score) will be measured before and after treatment as well as in 2 months follow up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016053021139N6
Registration date:2016-06-29, 1395/04/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-29, 1395/04/09
Registrant information
Name
Safoora Ebadi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 175 7107
Email address
ebadi.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2016-06-30, 1395/04/10
Expected recruitment end date
2016-09-26, 1395/07/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of home based exercise and routine physiotherapy on pain and function in patients with adhesive capsulitis of shoulder:a randomized clinical trial
Public title
Comparing exercising at home to routine physiotherapy on frozen shoulder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having adhesive capsulitis for more than 3 months; No history of surgery or fracture in upper extremity or spine; Not having any systemic disease; Have not received physiotherapy treatment of any kind during last 6 months; Not pregnant; Not having psychological problems or not using any medicine related to psychological problems
Exclusion Criteria:
Patients who are unwilling to continue treatment; Violation of any one of inclusion criteria
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization is by using sealed envelopes.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences ,Shahid Hemmat Highway .Tehran,1449614535,IRAN
City
Tehran
Postal code
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
IR.IUMS.REC 1394.00637663021
Health conditions studied
1
Description of health condition studied
Frozen shoilder
ICD-10 code
M75.0
ICD-10 code description
Frozen shoulder Periarthritis of shoulder
Primary outcomes
1
Description
Pain
Timepoint
Before treatment, After 10 sessions of treatment, In 2 months followup
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Function
Timepoint
Before treatment, After 10 sessions of treatment, In 2months followup
Method of measurement
Oxford Shoulder Score
Intervention groups
1
Description
Intervention group:
10 sessions of physiotherapy 3 days per week including physical modality, mobilization and specific strengthening and stretching exercises at home
Category
Rehabilitation
2
Description
Control group:
Learning to perform specific strengthening and stretching exercises at home and being advised to stay active at home
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Firouzgar Hospital
Full name of responsible person
Dr. Safoora Ebadi
Street address
Physical Medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin St., Karim khane zand St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr. Javad Ali Musavi
Street address
Iran University of Medical Sciences ,Shahid Hemmat Highway .Tehran,1449614535,IRAN
City
Tehran
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, Iran 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
Iran University of Medical Sciences; Faculty of Medicine
Full name of responsible person
Dr. Safoora Ebadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin St., Karim khane zand St.
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
Email
ebadi.s@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical sciences, Faculty of Medicine
Full name of responsible person
Dr. Safoora Ebadi
Position
Assistant professor, PhD Pt
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin St., Karim khane zand St.
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
Email
ebadi.s@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical sciences
Full name of responsible person
Dr. Safoora Ebadi
Position
Assistant professor, PhD pt
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin St., Karim khane zand St.
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
Email
ebadi.s@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)