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Comparison of application of the Radial Vs. focused probes of extracorporeal shockwave therapy on Pain, ROM, and function in patients with adhesive capsulitis

Protocol summary

Study aim
To compare application of the radial vs. focused probes of extracorporeal shockwave therapy on pain, range of motion, and function in patients with adhesive capsulitis
Design
Forty patients with adhesive capsulitis are divided into two intervention groups (radial and focused shockwave) by simple randomization using a sealed envelope. The study is double blinded and the third phase.
Settings and conduct
Adhesive capsulitis (AC) is an inflammatory disorder that causes shoulder stiffness and pain. Shockwave therapy is widely used for treatment of AC, although to our knowledge no research has directly compared the effectiveness of focused shockwave and radial shockwave on pain, range of motion, and function of patients with AC. This study will be performed on patients referred to the outpatient physiotherapy clinic of the School of Rehabilitation. The study will be double blinded. Patients have no knowledge about the type of the probe used and the coding to the evaluation forms will be used for blinding.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Participants above the age of 18 years old with definitive diagnosis of sub- acute and chronic unilateral adhesive capsulitis Exclusion Criteria: History of fractures, surgery and inflammatory arthropathy in shoulder, cancer, tumors, bleeding disorders, and Aspirin intake during the last 3 days
Intervention groups
Both intervention groups will receive routine treatments including infrared, ultrasound, supervised and home exercises. One of the intervention groups will receive the radial shockwave and the other, the focused shockwave.
Main outcome variables
Pain at rest and during exercise, range of motion, scapular dyskinesia, DASH (Disabilities of the arm, shoulder, and hand) score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210214050356N3
Registration date: 2022-03-21, 1401/01/01
Registration timing: prospective

Last update: 2022-03-21, 1401/01/01
Update count: 0
Registration date
2022-03-21, 1401/01/01
Registrant information
Name
Sara Fereydounnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 8468
Email address
s-fereydounnia@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2022-06-05, 1401/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of application of the Radial Vs. focused probes of extracorporeal shockwave therapy on Pain, ROM, and function in patients with adhesive capsulitis
Public title
Efficacy of mechanical wave in treatment of adhesive capsulitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants with sub-acute and chronic adhesive capsulitis (AC) A history of at least 4 months The diagnosis was confirmed clinically by physical examination The presence of AC on one side The age above 18 years old
Exclusion criteria:
Compound shoulder injuries Shoulder fractures Previous shoulder surgery Cancer Tumors Inflammatory Arthropathies of the Shoulder Bleeding disorders Anticoagulant medication Aspirin intake during the last 3 days Other pathologies of the shoulder such as tendonitis, and impingement
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
After initial assessments, patients are randomly assigned to one of the two groups of intervention 1 and intervention 2 (method: simple randomization - unit: individual). One envelope containing blue paper and one envelope containing red paper (randomization tool: sealed envelope) are given to the patients, if the patient choose the envelope containing blue paper, will be in the intervention group 1 and if he chose the envelope containing red paper will be in the intervention group 2.
Blinding (investigator's opinion)
Double blinded
Blinding description
As mentioned above, the study will be double-blinded. In this way, the participants do not know in which group they are. Participants only know that shockwave are used for them and have no knowledge of the type of probe (focused, radial). The data analyzer is also unaware of which study group the data belongs to. But the therapist, who is the one applying the different probes, assessing the outcome measures, knows the participants' groups
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Vice Chancellor for Research, 6th Floor, Central University Organization, Corner of Ghods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2022-03-06, 1400/12/15
Ethics committee reference number
IR.TUMS.FNM.REC.1400.216

Health conditions studied

1

Description of health condition studied
Adhesive Capsulitis of Shoulder
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder

Primary outcomes

1

Description
Pain at rest
Timepoint
Before intervention- After the last session of intervention
Method of measurement
Visual Analogue Scale

2

Description
Pain during activity
Timepoint
Before intervention- After the last session of intervention
Method of measurement
Visual Analogue Scale

3

Description
Range of Motion
Timepoint
Before intervention- After the last session of intervention
Method of measurement
Goniometer

4

Description
Function
Timepoint
Before intervention- After the last session of intervention
Method of measurement
The DASH (Disabilities of the Arm, Shoulder, and Hand) scale

5

Description
Scapular Dyskinesia
Timepoint
Before intervention- After the last session of intervention
Method of measurement
Caliper

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Group 1 (n = 20) will receive extracorporeal shockwave radial probe with conventional therapy (Infra-red, Ultrasound, supervised exercise & home exercises, two sessions in a week for four weeks.
Category
Rehabilitation

2

Description
Intervention group 2: Group 2 (n = 20) will receive extracorporeal shockwave focused probe with conventional therapy (Infra-red, Ultrasound, supervised exercise & home exercises, two sessions in a week for four weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Sara Fereydounnia
Street address
Vice Chancellor for Research and Technology, sixth floor, Central University Organization, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 7752 8468
Email
s-fereydounnia@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Vice Chancellor for Research and Technology, sixth floor, Central University Organization, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3639
Email
research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Sara Fereydounnia
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche- Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Fax
Email
S-fereydounnia@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Shadmehr
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche- Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Fax
Email
Shadmehr@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sara Fereydounnia
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche shemiran, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
s-fereydounnia@sina.tums.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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
Access period starts 3 months after the articles are published.
To whom data/document is available
For researchers working in academic, scientific and hospital institutions
Under which criteria data/document could be used
Researchers working in the field of musculoskeletal physiotherapy and electrotherapy.
From where data/document is obtainable
Applicants for documentation can contact Dr. Sara Fereydounnia via email. S-fereydounnia@sina.tums.ac.ir
What processes are involved for a request to access data/document
Once they have the necessary criteria, the information will be provided to them within a month.
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