The effectiveness of Exercise therapy with and without complementary shock wave therapy on the pain and range of motion in patients with frozen shoulder
The effectiveness of exercise therapy with and without complementary shock wave therapy on the pain and range of motion in patients with frozen shoulder
Design
Clinical trials with a control group and an experimental group will be performed in both blind and random directions. Randomization will be done by computer numbers
Settings and conduct
Experimental group received six sessions of 45 to 60 minutes (18 sessions) of exercise for six weeks each week, and from week 3 to 6 of training, will receive exercise therapy with shock wave (1 in 5 days until 4 sessions). Positive control group Includes basic exercises (Joint play movements, stretching exercises, manipulation and PNF exercises, range of motion exercises and strength exercises) for six weeks, from week 3 on wards to weeks 6, while the shock wave device will be turn off and will be put on the patient's shoulder for a similar time. Patients and investigator and data analyst will be blind to the study
Participants/Inclusion and exclusion criteria
Study entry requirements: Having symptoms and signs of frozen shoulder disease for at least 3 months; Frozen shoulder disease according to orthopedic specialist diagnosis; Significant loss of shoulder joint mobility in active and passive motion; Nocturnal pain and daily activity in the shoulder joint;
Study no entry requirements: Having a history of illness and underlying injuries affecting the frozen shoulder such as fracture, dislocation, joint instability; Having a history of neuromuscular skeletal disease; Rotator Cuff Muscle Tear; History of previous surgeries; History of taking any medication or painkiller and Use of therapeutic measures for frozen shoulder problems
Intervention groups
Control group: They will do a exercise therapy program. Experimental group: they will be treated with exercise therapy and shock wave.
Main outcome variables
Improves shoulder pain and range of motion
General information
Reason for update
Acronym
ESWT
IRCT registration information
IRCT registration number:IRCT20200326046866N1
Registration date:2020-10-06, 1399/07/15
Registration timing:registered_while_recruiting
Last update:2020-10-06, 1399/07/15
Update count:0
Registration date
2020-10-06, 1399/07/15
Registrant information
Name
Alireza Rouhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3557 9744
Email address
raana.dini@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-01, 1399/07/10
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Exercise therapy with and without complementary shock wave therapy on the pain and range of motion in patients with frozen shoulder
Public title
The effectiveness of Exercise therapy and complementary shock wave therapy on improving the situation in patients with frozen shoulder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
with symptoms and signs of frozen shoulder disease for at least 3 months
with Frozen shoulder disease according to orthopedic specialist diagnosis
Significant loss of shoulder joint mobility in active and passive motion
Nocturnal pain and daily activity in the shoulder joint
Age range 40 to 60 years
Exclusion criteria:
history of illness and underlying injuries affecting the frozen shoulder such as fracture, dislocation, joint instability
history of neuromuscular skeletal disease
Rotator Cuff Muscle Tear
History of previous surgeries
History of taking any medication or painkiller and Use of therapeutic measures for frozen shoulder problems
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
13
In case group: 13 patients with frozen shoulder and at least 3 months duration of symptoms without any comorbid disorders who will be treated with Exercise therapy and shock wave. Control group: In case group: 13 patients with frozen shoulder and at least 3 months duration of symptoms without any comorbid disorders who will be treated with physiotherapy
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups A and B using computer randomization (using Excel program). This arrangement is written in envelopes and Put in a box and When selecting patients, they are treated according to this sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients ,investigator and data analyst will be blind to the study
But consequence assessor and data supervisor committee will be aware of study.
Patients: shock wave probe are gonna applied in both groups
But in the control group it will be in off mode.
Investigator and data analyst: they are going to analyze the data without any information about patients groups.
Placebo
Used
Assignment
Parallel
Other design features
In the control group, patients will receive exercise therapy for up to six weeks. but In the intervention group, the treatment protocol is performed in such a way that patients do exercise therapy for up to three weeks. From week three onward, they will be treated with exercise therapy (on days when they do not exercise therapy) for up to six weeks with a shock wave.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz Universityy of Medical Sciences
Street address
Ashpaz bashi Restaurant, front of Tareh Bar Square, Sheikh Shaltout Blvd
City
urmia
Province
West Azarbaijan
Postal code
5714965314
Approval date
2020-09-14, 1399/06/24
Ethics committee reference number
IR.TBZMED.REC.1399.640
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
Improve pain
Timepoint
Before starting the intervention- Six weeks after the intervention
Method of measurement
Visual Analogue Scale - Constant Murley Score
2
Description
Improve range of motion
Timepoint
Before starting the intervention- Six weeks after the intervention
Method of measurement
Shoulder Pain And Disability Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: It will use a shock wave therapy device with the specifications of ROSETTA the CR technology made in South Korea. The treatment protocol will be such that the person is sitting in the shock wave group with the shoulder away from the center with the elbow curve at an angle of 45 degrees and the arm at rest. Shock waves will shine on the sensitive points near the Rotator cuff joint in the small protrusion of the bone, below the tip of the shoulder. Shock wave will be performed once every five days for 4 consecutive weeks and in each session 3000 shocks with a frequency of 10 Hz.
Category
Rehabilitation
2
Description
Control group: An exercise therapy program is offered for six weeks and three sessions each week (between 45 and 60 minutes) that From week three onward, they receive the same treatment as the experimental group for up to six weeks, While the shock wave device is off and is placed on the patient's shoulder at the same time.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Behbood Physiotherapy Clinic
Full name of responsible person
Dr Amin Abdali
Street address
Ashpaz bashi Restaurant, In front of Tareh Bar Square, Sheikh Shaltout Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714965314
Phone
+98 44 3238 6555
Email
Raana.dini@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Samiiy
Street address
Tabriz university of medical science,Abady Ave, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3335 7310
Email
herasat@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Alireza Rouhani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
5Floor, Hakim Building, New Pastour Ave
City
Tabriz
Province
East Azarbaijan
Postal code
515 774 4897
Phone
+98 41 3557 9744
Email
rouhani.m.d@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Alireza Rouhani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
5Floor, Hakim Building, New Pastour Ave
City
Tabriz
Province
East Azarbaijan
Postal code
515 774 4897
Phone
+98 41 3557 9744
Email
rouhani.m.d@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Alireza Rouhani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
5Floor, Hakim Building, New Pastour Ave
City
Tabriz
Province
East Azarbaijan
Postal code
515 774 4897
Phone
+98 41 3557 9744
Email
rouhani.m.d@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
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
In case of journal editor requesting
When the data will become available and for how long
After submission until article publication
To whom data/document is available
Editors and reviewers
Under which criteria data/document could be used
For the next studies
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document