Protocol summary

Study aim
The aim of this study is to compare the effects of Maitland mobilization techniques with and without Kinesio taping in patients with shoulder subacute adhesive capsulitis.
Design
Twenty four patients with adhesive capsulitis will be divided into two intervention and control groups (Kinesio taping plus Maitland Mobilization, and Maitland Mobilization alone) by simple randomization using a sealed envelope. The study is single blinded and the third phase.
Settings and conduct
Adhesive capsulitis is a disease characterized by limited active and passive range of motion at the glenohumeral joint, leading to pain and loss of motion. Maitland mobilization is used in the treatment of Adhesive capsulitis in physiotherapy. Kinesio taping is a non-invasive way of treating musculoskeletal injuries which mimics and improves the function of muscle fibers and tendons. This study will be performed on patients referred to the outpatient physiotherapy clinic of the School of Rehabilitation. The study will be single blinded. Patients have no knowledge about the type of the interventions used and the coding to the evaluation forms will be used for blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 40-60 years, primary type and sub- acute stage of adhesive capsulitis, restriction of movements in capsular Pattern. Exclusion criteria: History of shoulder dislocation, fractures and surgery, cervical spine symptoms, neurological condition, hypersensitivity to tape, uncontrolled diabetes, supraspinatus tendon rapture, major cardiopulmonary problems.
Intervention groups
Both groups will receive supervised exercises. Intervention group will receive the Maitland mobilization and kinesio taping, and the control group, the Maitland mobilization alone.
Main outcome variables
Pain, range of motion, Muscular torque, Shoulder Discomfort and Disability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210214050356N4
Registration date: 2022-08-02, 1401/05/11
Registration timing: registered_while_recruiting

Last update: 2022-08-02, 1401/05/11
Update count: 0
Registration date
2022-08-02, 1401/05/11
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
2022-07-23, 1401/05/01
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Maitland Mobilization Techniques with and without Kinesio Taping in Patients with Shoulder Subacute Adhesive Capsulitis
Public title
Manual Therapy and Taping in Adhesive Shoulder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 40-60 years Primary type and sub-acute stage of adhesive capsulitis Patients with minimum of grade 3 muscle strength Individuals with restriction of movements in capsular Pattern
Exclusion criteria:
History of shoulder dislocation and fractures Concomitant cervical spine symptoms History of shoulder surgery History of neurological condition (stroke, parkinsonism) Individuals with hypersensitivity to kinesio tape Individuals with uncontrolled diabetes Supraspinatus tendon rapture Major cardiopulmonary problems
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
After initial assessments, patients are randomly assigned to one of the two groups of intervention and control (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 and if the patient chose the envelope containing red paper will be in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
As mentioned above, the study will be single-blinded. In this way, the participants know in which group they are. Also the therapist, who is the one applying the different interventions and assessing the outcome measures, knows the participants' groups. But the data analyzer is unaware of which study group the data belongs to.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation- Tehran University of
Street address
Vice Chancellor for Research, 6th Floor, Central University Organization, Corner of Ghods St, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۵۳۷۶۱
Approval date
2022-07-05, 1401/04/14
Ethics committee reference number
IR.TUMS.FNM.REC.1401.037

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
Timepoint
Before intervention- After the last session of intervention
Method of measurement
Visual Analogue Scale

2

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

3

Description
Muscular Torque
Timepoint
Before intervention- After the last session of intervention
Method of measurement
Motion Analysis and software

4

Description
Shoulder Discomfort and Disability Index
Timepoint
Before intervention- After the last session of intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group (n = 12) will receive Maitland mobilization techniques plus kinesio taping with supervised exercise three sessions in a week for four weeks.
Category
Rehabilitation

2

Description
Control group (n = 12) will receive Maitland mobilization techniques with supervised exercise three 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
corner of Ghods Street, Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۵۳۷۶۱
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
۱۴۱۷۶۵۳۷۶۱
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 Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Fax
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 manual therapy.
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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