The effect of the kinetic chain exercise base approach on pain, disability, function, muscle strength and shoulder kinematics in patients with anterior shoulder instability: a randomized controlled trial
The purpose of this study is to investigate the effect of conventional physiotherapy along with designed exercises based on kinetic chain on pain, functional disability, muscle strength and kinematics of the scapula in people with anterior shoulder instability syndrome compared to people who receive conventional physiotherapy along with conventional exercises in this problem
Design
This study is a double-blind randomized controlled clinical trial with 42 participants
Settings and conduct
Comparison of exercises based on kinetic chain with conventional exercises, on patients referred to the Faculty of Rehabilitation, University of Iran. The assessor and the analyzor are unaware of the group of people
Participants/Inclusion and exclusion criteria
Include criteria: 1) Men and women 18 to 45 years old. 2) A history of one-way dislocation in the anterior direction of the shoulder. 3) The dislocation has been confirmed using MRI imaging methods and diagnosed by a orthopedic surgeon and has been closed reduction.
Exclude criteria: humeral head fractures and/or bony Bankart lesions that require early surgery (assessed by an orthopedic surgeon). 2) Previous surgery on the injured shoulder joint 3) Doubt about the diagnosis of certain diseases (such as rheumatoid arthritis, cancer, neurological disorders, fibromyalgia, mental illnesses). 4) Sensory and motor deficit in the neck and shoulder (damage to the roots of the brachial plexus nerves and damage to peripheral nerves branches from it that leads to sensory or motor disorders in the shoulder). 5) Child birth in the last six months.
Intervention groups
The treatment group: receiving basic treatment with kinetic chain exercises. The control group: receiving basic treatment and conventional exercises
Main outcome variables
Functional disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190315043058N4
Registration date:2024-04-10, 1403/01/22
Registration timing:prospective
Last update:2024-04-10, 1403/01/22
Update count:0
Registration date
2024-04-10, 1403/01/22
Registrant information
Name
Ismail Ebrahimi Takamjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2239 2426
Email address
ebrahimitakamjani.e@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the kinetic chain exercise base approach on pain, disability, function, muscle strength and shoulder kinematics in patients with anterior shoulder instability: a randomized controlled trial
Public title
The effect of the kinetic chain exercise on anterior shoulder instability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women age between 18 to 45 years
History of one-way dislocation in the anterior direction of the shoulder, so that it has happened one to three times
The dislocation has been confirmed using MRI imaging methods and diagnosed by a orthopedic surgeon and has been closed reduction manner
Patients are evaluated within 1 to 3 weeks after the current shoulder injury. This screening was done to ensure that all had completed initial immobilization of the shoulder after reduction
Exclusion criteria:
Humeral head fractures and/or bony Bankart lesions that require early surgery (assessed by an orthopedic surgeon)
Previous surgery on the injured shoulder joint
Doubtful of diagnoses of certain diseases (such as rheumatoid arthritis, cancer, neurological disorders, fibromyalgia, mental disorder )
Sensory and motor deficits in the neck and shoulder (damage to the roots of brachial plexus nerves and damage to peripheral nerves branching from it that leads to sensory or motor impairment in the shoulder)
Giving birth in the last six months
Failure to complete/absence from more than two consecutive sessions or three alternate sessions
Disorders such as stroke, epilepsy and Parkinson's or cognitive impairment
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
After the initial assessment, the samples that meet the include criteria the study and do not exclude criteria, through simple randomization method and creating random blocks of 4 or 6 equally into two treatment intervention groups (kinetic chain exercise based treatment) 21 persons and the control group (conventional treatment) 21 persons will be divided. The random sequence will be created using the randomization website. The person who creates the random sequence will not be involved in any other phase of the research
Blinding (investigator's opinion)
Double blinded
Blinding description
The assessor does not know which group the participants are in, either control or treatment.
The analyzer also does not know which 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
Ethics committee of Iran university of medical sciences
Street address
Hemmat Highway., next to Milad Tower Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1341853347
Approval date
2024-03-13, 1402/12/23
Ethics committee reference number
IR.IUMS.REC.1402.1216
Health conditions studied
1
Description of health condition studied
People with traumatic dislocation of the shoulder in anterior direction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Functional disability
Timepoint
Before starting the treatment, after the last treatment session and three months after the last treatment session as a follow-up
Method of measurement
Persian version of Western Ontario Shoulder Instability (WOSI)
Secondary outcomes
1
Description
Pain intensity
Timepoint
Before starting the treatment, after the last treatment session and three months after the last treatment session as a follow-up
Method of measurement
Visual Analogue Scale
2
Description
Kinesiophobia
Timepoint
Before starting the treatment, after the last treatment session and three months after the last treatment session as a follow-up
Method of measurement
Persian version of Tampa Scale Kinesiophobia
3
Description
Active and passive rang of motion
Timepoint
Before starting the treatment, after the last treatment session and three months after the last treatment session as a follow-up
Method of measurement
The active range of motion of participant using the motion capture system and the passive range of participant without pain were measured using the clinometer application installed on the smartphone.
4
Description
Scapular kinematic
Timepoint
After last treatment session
Method of measurement
Using Motion Capture analysis system
5
Description
Strength
Timepoint
Before starting the treatment, after the last treatment session
Method of measurement
Manual dynamo-meter
Intervention groups
1
Description
Intervention group: Specific exercises based on the rehabilitation of the shoulder kinetic chain in addition to basic treatment that includes the use of electrical stimulation currents for pain control and muscle retraining for the rotator cuff muscles will be used. The parameters of the electric currents used include conventional TENS with a frequency of 150 Hz and a pulse duration of 50 microseconds, and also for muscle training functional faradic with parameters of a frequency of 30 Hz and a pulse duration of 300 microseconds and a 1 to 1 On/Off time will be used. Patient's sensation: Tingling will be within the patient's tolerance range.
Category
Treatment - Other
2
Description
Control group: Conventional exercises related to anterior shoulder instability in addition to basic treatment that includes the use of electrical stimulation currents for pain control and muscle retraining for the rotator cuff muscles will be used. The parameters of the electric currents used include conventional TENS with a frequency of 150 Hz and a pulse duration of 50 microseconds, and also for muscle training functional faradic with parameters of a frequency of 30 Hz and a pulse duration of 300 microseconds and a 1 to 1 On/Off time will be used. Patient's sensation: Tingling will be within the patient's tolerance range.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy Clinic of Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Javad Abdolhamidi
Street address
Shahnazari Ave., Mirdamad Blvd., Tehran Town
City
Tehran
Province
Tehran
Postal code
1998135353
Phone
+98 21 2222 2167
Email
abdolhamidi.pt@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Reza Falak
Street address
Hemmat Highway., Next to Milad Tower., Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86710
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Esmaeel Ebrahimi Takamjani
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shahnazari Ave., Mirdamad Blvd., Tehran Town
City
Tehran
Province
Tehran
Postal code
1998135353
Phone
+98 21 2239 2426
Email
ebrahimitakamjani.e@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Javad Abdolhamidi
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Shahnazari Ave., Mirdamad Blvd., Tehran Town
City
Tehran
Province
Tehran
Postal code
1998135353
Phone
+98 21 2239 2426
Email
abdolhamidi.pt@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Esmaeel Ebrahimi Takamjani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shahnazari Ave., Mirdamad Blvd., Tehran Town
City
Tehran
Province
Tehran
Postal code
1998135353
Phone
+98 21 2239 2426
Email
abdolhamidi.pt@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available