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Comparing the Effects of Instrument-Assisted Soft Tissue Mobilization and Self-Stretching Techniques To Improve Pain, Range of Motion and Function in Athletes with Subacromial Impingement Syndrome

Protocol summary

Study aim
The aim of this study is to compare the effects of instrument assisted soft tissue mobilization and self-stretching techniques to improve shoulder pain, range of motion and function in athletes with subacromial impingement syndrome
Design
Randomized clinical trial; a single blinded study
Settings and conduct
Future Badminton Academy, Single blinded study (assessors of the study would be kept blind of the treatment group to which the patient will be allocated)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 20-40 years old, Both male and female athletes, Athletes with painful arc, Athletes with positive Hawkins–Kennedy and Neers sign, Athletes with unilateral/bilateral impingement. Non-inclusion criteria: Any other musculoskeletal disorder of shoulder, Any Previous surgery of shoulder, Patients with co-morbidities, Hypertension, Diabetes
Intervention groups
Control group: they will get Self-stretching techniques (e.g., cross body stretch, sleeper stretch) using towel, shoulder pulleys or Thera-bands, each technique was performed for at least 5-7 times with 5-10 seconds hold under the supervision of physiotherapist with proper instructions with base line treatment (Hot pack for 10 minutes, TENS 15 minutes) before stretching. Intervention group: they will get Hawk grip (HGPro multitool) under the supervision of Hawk-grip IASTM practitioner. Starting with the superficial muscles of the shoulder girdle, continuing along the intrascapular region and up into the cervical region main focus was on rotator cuff muscles (supraspinatus, infraspinatus, teres minor, subscapularis) with base line treatment (Hot Pack for 10 mint, TENS 15 min) before IASTM.
Main outcome variables
Function, Pain, Range of motion of shoulder

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210530051449N1
Registration date: 2021-09-24, 1400/07/02
Registration timing: retrospective

Last update: 2021-09-24, 1400/07/02
Update count: 0
Registration date
2021-09-24, 1400/07/02
Registrant information
Name
Urooj Afzal
Name of organization / entity
Riphah international univeristy lahore
Country
Pakistan
Phone
+92 42 35325503
Email address
uroojafzal95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-05, 1399/10/16
Expected recruitment end date
2021-06-05, 1400/03/15
Actual recruitment start date
2021-02-05, 1399/11/17
Actual recruitment end date
2021-07-05, 1400/04/14
Trial completion date
2021-07-05, 1400/04/14
Scientific title
Comparing the Effects of Instrument-Assisted Soft Tissue Mobilization and Self-Stretching Techniques To Improve Pain, Range of Motion and Function in Athletes with Subacromial Impingement Syndrome
Public title
Effects of Instrument-Assisted Soft Tissue Mobilization and Self-Stretching Techniques On Pain, Range of Motion and Function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 20-40 years old Both male and female athletes Athletes with painful arc Athletes with positive Hawkins–Kennedy and Neers sign Athletes with unilateral/bilateral impingement
Exclusion criteria:
Any other musculoskeletal disorder of shoulder Any Previous surgery of shoulder Patients with co-morbidities Hypertension Diabetes
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 26
Actual sample size reached: 22
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects fulfilling the inclusion criteria will be enrolled after independent outcome assessor then, coin toss method will be used for randomization. We simply flip the coin into the air and seeing which side lands facing up. The subject's randomization method reduces the chances of bias group allocation.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study would be single blinded as assessor of the study will be kept blind of the treatment group to which the patient will be allocated.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research & Ethical Review Committee, Riphah College of Rehab. & Allied Health Sciences.
Street address
Madar-e-Millat Road, Quaid-e-Azam Industrial Estate Quaid e Azam Industrial Estate, Lahore, Punjab
City
Lahore
Postal code
54000
Approval date
2020-12-24, 1399/10/04
Ethics committee reference number
REC/RCR & AHS/20/0406

Health conditions studied

1

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

Primary outcomes

1

Description
Pain
Timepoint
Before treatment and then on 6th week
Method of measurement
Numeric pain rating scale

2

Description
Function
Timepoint
Before treatment and on 6th week
Method of measurement
Oxford shoulder score

3

Description
Range of Motion
Timepoint
Before treatment and on 6th week
Method of measurement
Universal Goniometer

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Self-stretching techniques (e.g., cross body stretch, sleeper stretch) using towel, shoulder pulleys or Thera-bands were used on Group A, each technique was performed for at least 5-7 times with 5-10 seconds hold under the supervision of physiotherapist with proper instructions with base line treatment (Hot pack for 10 minutes, TENS 15 minutes) before stretching
Category
Rehabilitation

2

Description
Intervention group: Hawk grip (HGPro multitool) was used on group B under the supervision of Hawk-grip IASTM practitioner. Starting with the superficial muscles of the shoulder girdle, continuing along the intrascapular region and up into the cervical region main focus was on rotator cuff muscles (supraspinatus, infraspinatus, teres minor, subscapularis) with base line treatment (Hot Pack for 10 mint, TENS 15 min) before IASTM.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Future Badminton Academy
Full name of responsible person
Dr Muteeb Sohail Dar
Street address
Johar Town Badminton Hall
City
Lahore
Postal code
54000
Phone
+92 544 270702
Email
Fbcop321@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University, Lahore
Full name of responsible person
Urooj Afzal
Street address
Madar-e-Millat Road, Quaid-e-Azam Industrial Estate Quaid e Azam Industrial Estate, Lahore, Punjab
City
Lahore
Postal code
54000
Phone
+92 42 37414349
Email
uroojafzal95@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University, Lahore
Proportion provided by this source
100
Public or private sector
Private
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
Riphah International University, Lahore
Full name of responsible person
Tasneem Shehzadi
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Madar-e-Millat Road, Quaid-e-Azam Industrial Estate Quaid e Azam Industrial Estate, Lahore, Punjab
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 111 747 424
Email
tasneem.shehzadi@riphah.edu.pk
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah International University, Lahore
Full name of responsible person
Tasneem Shehzadi
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Madar-e-Millat Road, Quaid-e-Azam Industrial Estate Quaid e Azam Industrial Estate, Lahore, Punjab
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 111 747 424
Email
Tasneem.shehzadi@riphah.edu.pk
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Riphah International University, Lahore
Full name of responsible person
Urooj Afzal
Position
Post graduate student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Madar-e-Millat Road, Quaid-e-Azam Industrial Estate Quaid e Azam Industrial Estate, Lahore, Punjab
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 111 747 424
Email
uroojafzal95@gmail.com
Web page address

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
Yes - There is a plan to make this available
Title and more details about the data/document
All collected deidentified IPD will be shared.
When the data will become available and for how long
After Publication
To whom data/document is available
people working in academic institutions and researchers
Under which criteria data/document could be used
on permission from investigator
From where data/document is obtainable
Through email to Investigator uroojafzal95@gmail.com
What processes are involved for a request to access data/document
Through email to Investigator uroojafzal95@gmail.com
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