IRCT | Comparative study of the effect of kinesiotype and corrective movements on pain and shoulder function in impingement syndrome of shoulder

Protocol summary

Study aim: Determining and comparing the effect of kinesiotype and corrective movements on pain and shoulder function in impingement syndrome of shoulder
Design: The clinical trial has a control group, with parallel groups, single-blind, randomized, phase 3-2 on 50 patients, which will use random allocation software for randomization.
Settings and conduct: A single-blind clinical trial study will be performed to evaluate the effect of two methods of kinesiotype and corrective movements on shoulder pain and function in 50 patients with shoulder impingement syndrome referred to physical medicine clinics affiliated to Isfahan University of Medical Sciences in 2020.
Participants/Inclusion and exclusion criteria: Inclusion criteria include patients diagnosed with impingement syndrome of shoulder. Exclusion criteria include history of dislocation and traumatic injury and history of surgery on the shoulder joint, rotator cuff muscle rupture, shoulder joint instability, neurological problems of the neck, history of shoulder injection or shoulder or neck physiotherapy in the last six months, history of neurological diseases, the presence of any skin disease around the shoulder and scapula.
Intervention groups: For all patients, the required medication will be prescribed by a doctor. In addition, sports intervention will be prescribed for both groups in accordance with sports instructions to increase range of motion. Patients in the control group do not receive any other intervention, but for patients in the intervention group, in addition to medication and exercise, the kinesiotype tape will be used once a week during four weeks.
Main outcome variables: Shoulder pain, shoulder function

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20200825048515N3

Registration date: 2020-09-21, 1399/06/31

Registration timing: prospective

Last update: 2020-09-21, 1399/06/31

Update count: 0
Registration date: 2020-09-21, 1399/06/31

Registrant information: Name

Asieh Maghami Mehr

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 31 0000 0000

Email address

asimaghami@yahoo.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2020-10-22, 1399/08/01
Expected recruitment end date: 2021-03-21, 1400/01/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparative study of the effect of kinesiotype and corrective movements on pain and shoulder function in impingement syndrome of shoulder

Public title: The effect of kinesiotype and corrective movements on pain and shoulder function in impingement syndrome of shoulder
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Age over 18 years Diagnosis of impingement syndrome of shoulder by a physical therapist Satisfaction to participate in the study

Exclusion criteria:

1. History of dislocation and traumatic injury and history of surgery on the shoulder joint Deformity of the scapula and hunched back with the diagnosis of a physician specializing in physical medicine Rotator cuff muscle rupture Shoulder joint instability Neurological problems of the neck, such as neck radiculopathy Rheumatic diseases and destructive changes in the joints History of shoulder injection or shoulder or neck physiotherapy in the last six months by reviewing the patient's medical record History of neurological diseases such as stroke, multiple sclerosis The presence of any skin disease around the shoulder and scapula
Age: From 18 years old
Gender: Both

Phase

2-3

Groups that have been masked

Outcome assessor
Data analyser

Sample size

Target sample size: 50

Randomization (investigator's opinion)

Randomized

Randomization description

First, eligible patients will be selected using non-probability consecutive.Then, all patients are coded using computer randomization method using random allocation software and the codes will be randomly assigned to the intervention and control groups according to the order.

Blinding (investigator's opinion)

Single blinded

Blinding description

Given that the two methods of intervention are different, the researcher and the patient are aware of the two groups, but the person evaluating the patient's outcomes and the data analyst will not know the type of intervention.

Placebo

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 Jarib Ave, Azadi Square.

City

Isfaha

Province

Isfehan

Postal code

8174673461
Approval date: 2019-12-08, 1398/09/17
Ethics committee reference number: IR.MUI.MED.REC.1399.374

Health conditions studied

1

Description of health condition studied: Impingement syndrome of shoulder
ICD-10 code: M75.4
ICD-10 code description: Impingement syndrome of shoulder

Primary outcomes

1

Description: Shoulder pain
Timepoint: Before and three weeks after the intervention
Method of measurement: Visual analog scale(VAS)

2

Description: Shoulder function
Timepoint: Before and three weeks after the intervention
Method of measurement: By criteria Disabilities of the Arm, Shoulder and Hand (DASH)

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: For all patients, meloxicam 15 mg tablets daily, as well as baclofen tablets, half a tablet on the first night and on the following nights, one tablet every night will be recommended, which will be used for 3 weeks. Exercise intervention will also prescribe exercises for increasing range of motion three times a day for both groups and five times each time following the exercise instructions. This exercise may be unique to each patient depending on the patient's condition and the amount of pain. For patients in the intervention group, in addition to medication and exercise, the kinesiotype tape will be used once a week during four weeks.
Category: Treatment - Other

2

Description: Control group: For all patients, meloxicam 15 mg tablets daily, as well as baclofen tablets, half a tablet on the first night and on the following nights, one tablet every night will be recommended, which will be used for 3 weeks. Exercise intervention will also prescribe exercises for increasing range of motion three times a day for both groups and five times each time following the exercise instructions. This exercise may be unique to each patient depending on the patient's condition and the amount of pain. Patients in the control group do not receive any other intervention.
Category: N/A

Recruitment centers

1

Recruitment center: Name of recruitment center

Physical medicine clinics affiliated to Isfahan University of Medical Sciences

Full name of responsible person

Parisa Taheri

Street address

Office of Physical Medicine, Al-Zahra Hospital, Sefeh St., Isfahan

City

Isfahan

Province

Isfehan

Postal code

8174675731

Phone

+98 31 3668 5555

Fax

Email

Prs_taheri@yahoo.com

1

Sponsor: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Shaghayegh Haghjoo Javanmard

Street address

Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.

City

Isfahan

Province

Isfehan

Postal code

8174673461

Phone

+98 31 3668 8597

Email

dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: No
Title of funding source: Isfahan 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

Parisa Taheri

Position

Assistant Professor

Latest degree

Specialist

Other areas of specialty/work

Physical Medicine

Street address

Office of Physical Medicine, Al-Zahra Hospital, Sefeh St., Isfahan

City

Isfahan

Province

Isfehan

Postal code

8174675731

Phone

+98 31 3668 5555

Email

Prs_taheri@yahoo.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Parisa Taheri

Position

Assistant Professor

Latest degree

Specialist

Other areas of specialty/work

Physical Medicine

Street address

Office of Physical Medicine, Al-Zahra Hospital, Sefeh St., Isfahan

City

Isfahan

Province

Isfehan

Postal code

8174675731

Phone

+98 31 3668 5555

Email

Prs_taheri@yahoo.com

Person responsible for updating data

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Zahra Shirani

Position

Resident

Latest degree

Medical doctor

Other areas of specialty/work

Medical Physics

Street address

Ayatollah Khademi St., Foroughi St.

City

Isfahan

Province

Isfehan

Postal code

8179969220

Phone

+98 31 3668 3255

Email

zahrashirani278@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD: There is no further information
Study Protocol: No - There is not a plan to make this available
Statistical Analysis Plan: No - There is not a plan to make this available
Informed Consent Form: No - There is not 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: No - There is not a plan to make this available

Comparative study of the effect of kinesiotype and corrective movements on pain and shoulder function in impingement syndrome of shoulder