The results of this study may help to improve the therapeutic quality of Frozen Shoulder patients and determine which of the two standard physiotherapy and Tecar therapy can improve the shoulder range of motion and Shoulder Pain and Disability Index in these patients. It also can help physiotherapists choose the most effective treatment for frozen shoulder patients.
Design
Double blind RCT, with control and intervention group, with sample size of 15 patient in each group. Grouping is done randomly through the random number table.
Settings and conduct
The study is being conducted in a private physiotherapy clinic. All participants are evaluated for passive shoulder range of motion by Inclinometer and for shoulder pain and disability index by this questionnaire before, one day after and 4 weeks after the end of treatments. Participants and assessor are blind of the type of treatment and treatment groups.
Participants/Inclusion and exclusion criteria
Participants in this study are male and female patients with frozen shoulder between 41 to 72 years old, with shoulder pain and movement limitation for at least 3 months, and the limitation of passive external rotation of the shoulder greater than 30 degree compared to the contralateral side.
Patients with bilateral frozen shoulder and those with systemic inflammatory diseases, malignancies, complete rotator cuff tear, history of shoulder joint surgery and ... are excluded from this study.
Intervention groups
In this study, both control and intervention groups receive 8 session of standard physiotherapy treatment; consisting of continuous ultrasound and TENS over the shoulder joint and home exercise program. The intervention group will receive 10 minute Tecar therapy at the end of each session following standard physiotherapy.
Main outcome variables
Shoulder Pain and disability Index; Passive shoulder range of motion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191130045550N1
Registration date:2020-01-07, 1398/10/17
Registration timing:prospective
Last update:2020-01-07, 1398/10/17
Update count:0
Registration date
2020-01-07, 1398/10/17
Registrant information
Name
Maryam Raeisi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3420 1795
Email address
m.raeisi@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-15, 1398/12/25
Expected recruitment end date
2020-11-10, 1399/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Tecar therapy on shoulder passive Range of Motion and Shoulder Pain and Disability Index in patients with frozen shoulder
Public title
Evaluating the effect of Tecar therapy in patients with frozen shoulder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female patients with Frozen Shoulder between 41 and 72 years of age
Shoulder pain and movement limitation of minimum 3 months duration
Restriction of passive external rotation more than 30° in the glenohumeral joint compared to the contralateral side
Restriction of passive motion of at least a second plane of movement more than 30° in the glenohumeral joint compared to the contralateral side
Have enough ability to fill out the questionnaire
Exclusion criteria:
Bilateral Frozen shoulder
Systemic inflammatory joint disease like Rheumatoid arthritis, psoriasis arthritis and ...
Malignancies
Medical conditions such as cardiac diseases, infections and coagulation disorders
Full thickness tear of rotator cuff
History of shoulder joint surgery
Neurological disorders of the upper limb
Osteoarthritis of the glenohumeral joint
Fractures of upper limb
Cervical radiculopathy
Impaired sensation of hot and cold
Subjects who had a cardiac pacemaker
Pregnancy
Subjects who had physiotherapy treatment in the past 6 weeks
Taking analgesic or anti-inflammatory drugs
Age
From 41 years old to 72 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Half of all sample numbers will be randomly selected from the random number table to form Group 1 and the remaining numbers will be Group 2.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are blind to which of the two intervention control groups. The person evaluating the data is a person other than the researcher and is kept blind and unaware of the treatment group.
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 Sciences
Street address
Hezar jerib Ave., Isfahan University Of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
0000081746
Approval date
2019-11-12, 1398/08/21
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.447
Health conditions studied
1
Description of health condition studied
Frozen shoulder
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder
Primary outcomes
1
Description
Shoulder joint passive range of motion
Timepoint
Before treatment, 1 days after last session, 4 weeks after treatment
Method of measurement
Digital inclinometer
2
Description
Shoulder Pain and Disability Index
Timepoint
Before treatment, 1 days after last session, 4 weeks after treatment
Method of measurement
shoulder pain and disability index Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Standard physiotherapy and Tecar therapy, 8 session every other day, including 5 minute continuous ultrasound on the shoulder joint, 20 minute TENS on the shoulder joint, therapeutic exercise, Tecar therapy 10 minute on the shoulder joint
Category
Rehabilitation
2
Description
Control group: Standard physiotherapy, 8 session every other day, including 5 minute continuous ultrasound on the shoulder joint, 20 minute TENS on the shoulder joint, therapeutic exercise
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tan Aram Private physiotherapy clinic
Full name of responsible person
Maryam Raeisi
Street address
Unit 2, Elahieh Complex, Shahid Turki Alley, Sohrevardi Ave.
City
Isfahan
Province
Isfehan
Postal code
8177799886
Phone
+98 31 3777 2458
Email
maraym.raeisi92@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh HaghJoo Javanmard
Street address
Building 4, Hezar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
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
Maryam Raeisi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
0000081746
Phone
+98 31 3792 5000
Fax
Email
m.raeisi@rehab.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Raeisi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
0000081746
Phone
+98 31 3792 5000
Fax
Email
m.raeisi@rehab.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Raeisi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
0000081746
Phone
+98 31 3792 5000
Fax
Email
m.raeisi@rehab.mui.ac.ir
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 potential data is shared after unidentifiable people.
When the data will become available and for how long
Start of access period from 2021
To whom data/document is available
Researchers working in academic and scientific institutions