Comparison of rotational and elevatory resistive exercises on acromiohumeral distance in people with shoulder impingement syndrome: A randomized clinical trial
Comparison of the effect of rotational and elevatory resistance exercises on acromiohumeral distance in patients with shoulder impingement syndrome
Design
54 patients with shoulder impingement syndrome are randomly divided into 3 groups. The study is a randomized clinical trial. The Stratified Permuted Block Randomization method is used for randomization. The two intervention groups receive exercise therapy and the third group is considered as the control group. Acromiohumeral distance measurement is done once before the intervention and once after the intervention.
Settings and conduct
This study is performed at the neuromuscular Rehabilitation Research Center. Patients are invited to participate in the study based on their physician's diagnosis
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1.Aged 17 to 35 years 2.History of pain in anterior and lateral of the upper shoulder that has lasted more than a week in the last six months 3. Having at least three of the following: Positive Neer test - Positive Hawkins kennedy test - Positive Job test - Painful arch during flexion and abduction movements - Pain during resisted lateral rotation and / or resisted abduction
Exclusion criteria:Body mass index (BMI) above 25 kg/m2. Complete rupture of the rotator cuff. Moderate to severe glenohumeral or acromioclavicular joint osteoarthritis. Glenohumeral joint instability including previous dislocation or subluxation. Previous shoulder fracture
Intervention groups
The intervention of the first group is rotational resistance exercises and the intervention of the second group is elevatory resistance exercises. The control group does not receive any intervention and is only evaluated.
Main outcome variables
Measurement of acromiohumeral distance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211229053567N1
Registration date:2022-01-17, 1400/10/27
Registration timing:prospective
Last update:2022-01-17, 1400/10/27
Update count:0
Registration date
2022-01-17, 1400/10/27
Registrant information
Name
Cyrus Taghizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 1022
Email address
mohsen.pkdmn.1376@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of rotational and elevatory resistive exercises on acromiohumeral distance in people with shoulder impingement syndrome: A randomized clinical trial
Public title
The effect of rotational and elevatory resistive exercises on acromiohumeral distance in patients with shoulder impingement syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 17 to 35 years
History of pain in anterior and lateral of the upper shoulder that has lasted more than a week in the last six months
Having at least three of the following: Positive Neer test ;Positive Hawkins-kennedy test ;Positive Job test ;Painful arch during flexion and abduction movements ;Pain during resisted lateral rotation and / or resisted abduction
Exclusion criteria:
Body mass index (BMI) above 25 kg/m2.
Complete rupture of the rotator cuff
Moderate to severe glenohumeral or acromioclavicular joint osteoarthritis
Glenohumeral joint instability including previous dislocation or subluxation
Previous shoulder fracture
Neurological defect of the upper limb
Systemic diseases such as rheumatoid arthritis
Neck pain with somatic or radicular pain pattern
Previous history of shoulder surgery
Corticosteroid injection in the shoulder during the last month
Loss of range of motion of the shoulder joint (for example due to adhesions)
Malignancy and hemophilia
Deformity in the shoulder
Osteoporosis
Any history of damage to the brachial plexus
Any subcutaneous inflammation
Age
From 17 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are randomly assigned using the Stratified Permuted Block Randomization method with 6 9 blocks assigned to three groups. In this method, A will represent group one (rotational resistance exercises), B will represent group two (elevatory resistance exercises) and C will represent the control group. In this way, the order of interventions A, B and C in the form of blocks from 1 to 6 is determined by the methodological consultant of the project, and is provided to the executive supervisor of the project, and the researcher obtains an assignment from the executive supervisor to assign each qualified person. Slowly The supervisor first selects the block using a random number generator (or dice) and then the eligible individuals are assigned to one of three groups A, B or C in a predetermined order. It should be noted that if a block is selected based on random numbers that have already filled all 9 sequences, another random number will be selected again for that person.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees of Semnan University Of Medical Sciences and Health Services
Street address
Semnan university of medical sciences , Basij Blvd , Semnan city
City
Semnan
Province
Semnan
Postal code
35147-99442
Approval date
2021-12-28, 1400/10/07
Ethics committee reference number
IR.SEMUMS.REC.1400.236
Health conditions studied
1
Description of health condition studied
shoulder impingement syndrome
ICD-10 code
M75.4
ICD-10 code description
Impingement syndrome of shoulder
Primary outcomes
1
Description
Acromiohumeral distance
Timepoint
Before the intervention and after the intervention
Method of measurement
Ultrasonography device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Rotational shoulder resistance exercises are performed three times a week for 6 consecutive weeks, including 1) The patient is placed in a sitting position on a chair and the therapist stands on the affected side and the patient's elbow is placed at 90 degrees flexion. The patient moves the internal rotation of the arm from the end of the external rotation range to the end of the internal rotation range against the therapist's resistance. In order to prevent compensatory movements in the shoulder, the therapist holds the patient's elbow steady with one hand and applies resistance with the other hand on the end of the patient's forearm. The patient stands and elbows are placed at 90 degrees of flexion. The patient moves the external rotation of the arm from the end of the internal rotation range to the end of the external rotation range against the therapist's resistance. In order to prevent compensatory movements in the shoulder, the therapist holds the patient's elbow with one hand and applies resistance with the other hand on the end of the patient's forearm. 3) The patient is placed in a sitting position and the therapist is on the affected side Stand and elbow at 90 degrees flexion. The patient is asked to place the shoulder at angles of 30, 90, and 150 degrees around the scapula, and then the therapist applies force to the end of the patient's forearm to create internal rotation and external rotation of the arm, and the patient is asked to contract. Keep the shoulder isometric in the same position. In order to prevent compensatory movements in the shoulder, the therapist holds the patient's elbow with his hand.
Category
Treatment - Other
2
Description
Intervention group 2: elevatory shoulder resistance exercises are performed three sessions per week for 6 consecutive weeks, including 1) the patient is sitting on a chair and the therapist is standing on the affected side. The elbow is slightly bent at the flexion and thumb to create an external rotation in the arm facing the ceiling. The patient is then asked to move his or her process on the scapula to an angle of 150 degrees against resistance by the therapist. In order to apply the resistance force, the therapist's hand is placed on the end of the patient's forearm. 2) The patient is placed in a sitting position and the therapist stands on the affected side. The elbow is slightly bent at the flexion and thumb to create an external rotation in the arm facing the ceiling. The patient is asked to place the shoulder at 30, 90, and 150 degrees of rotation at the scapula, and then the therapist randomly applies force to the patient's forearm to raise and lower the patient's shoulder, and the patient is asked to contract. Maintain the isometric shoulder in the same position.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences
Full name of responsible person
Cyrus Taghizadeh
Street address
Qods Blvd, Semnan City
City
Semnan
Province
Semnan
Postal code
35196-98375
Phone
+98 23 3332 8502
Email
nmrrc@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohamad Khani
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan city
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3344 1022
Email
info@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Cyrus Taghizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan city
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3344 1022
Email
info@semums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Syrus Taghizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Semnan University of Medical Sciences.Basij Blvd, Semnan city
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3344 1022
Email
info@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Cyrus Taghizade
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan city
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3344 1022
Email
info@semums.ac.ir
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available