Protocol summary

Study aim
To compare the effects of pectoralis minor stretch with and without myofascial release on pain, range of motion and functional performance in Tennis players with sub-acromial impingement.
Design
Randomized Clinical Trial (RCT), Parallel group, Convenient sampling and sample size is 54. Simple randomization involves using a random process to allocate participants to different groups, ensuring that each participant has an equal chance of being assigned to any group. Multi centre study.
Settings and conduct
Data will be collected from different tennis clubs and allocated into two groups randomly. 1. Pakistan Sports Board and coaching center. 2. K21 Sports Academy, Model town.
Participants/Inclusion and exclusion criteria
Inclusion criteria Males & Females, Age group between 15-28, ROM reduced 10 degrees IR., NPRS indicating 4-6 Shoulder pain and discomfort due to overhead activities, Patients who show positive Neer sign, Hawkins-Kennedy test, Empty can test. Exclusion criteria Non-athletes, Players having any systemic and musculoskeletal disease or any recent trauma or dislocation, Excluded if they had Ligament laxity based on Positive Sulcus Test, had Apprehension during Apprehension Test, Bilateral shoulder pain, History of Intra-articular injection.
Intervention groups
After the baseline treatment given to all subjects, Group A: Pectoralis minor stretch Group B: Pectoralis minor stretch with myofascial release Common Treatment: The baseline treatment for subacromial impingement is to apply heating pad for warming the shoulder joint to reduce pain.
Main outcome variables
Pain (Numeric Pain rating scale) Range of motion (Goniometer) Functional performance (SPADI)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210811052138N5
Registration date: 2023-04-15, 1402/01/26
Registration timing: registered_while_recruiting

Last update: 2023-04-15, 1402/01/26
Update count: 0
Registration date
2023-04-15, 1402/01/26
Registrant information
Name
Halima Shoukat
Name of organization / entity
Riphah international university, Lahore
Country
Pakistan
Phone
+92 55 4284121
Email address
halima.shoukat@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-15, 1401/12/24
Expected recruitment end date
2023-09-13, 1402/06/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Pectoralis minor stretch with and without Myofascial release on pain, range of motion and functional performance in Tennis players with Sub-acromial impingement
Public title
Comparison of pectoralis minor stretch and myofascial release in shoulder impingement in tennis players
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who show positive Neer sign, Hawkins-Kennedy test, Empty can test. ROM reduced 10 degrees IR. NPRS indicating 4-6 Shoulder pain and discomfort due to overhead Activities Males & females both
Exclusion criteria:
Non athletes Players having any systemic and musculoskeletal disease or any recent trauma or dislocation Excluded if they had Ligament laxity based on Positive Sulcus Test, had Apprehension during Apprehension Test Bilateral shoulder pain History of Intra-articular injection
Age
From 15 years old to 28 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
The random allocation in this study was done using a simple randomization method. To allocate the participants to the two groups, a random table method was used. This involved using a table of random numbers to assign participants to either group, ensuring that each participant had an equal chance of being allocated to either group. By identifying a range of numbers that corresponds to the total number of participants then select a starting point in the table of random numbers and read the digits in pairs, matching each pair with a participant number until all participants have been allocated to a group.
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 Committee of Riphah College of Rehabilitation and 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
54770
Approval date
2022-11-07, 1401/08/16
Ethics committee reference number
REC/RCR & AHS/22

Health conditions studied

1

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

Primary outcomes

1

Description
Pain
Timepoint
Baseline treatment - 6 weeks regimen
Method of measurement
Numeric Pain rating scale

2

Description
Range of motion
Timepoint
Baseline treatment - 6 weeks regimen
Method of measurement
Goniometer

3

Description
Functional performance
Timepoint
Baseline treatment - 6 weeks regimen
Method of measurement
SPADI

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Pectoralis minor stretch after baseline treatment of hot pack. Subject begin in a standing upright position in the center of a doorway. With the elbow bent, place forearm on the side of doorway at a 90 degree angle from a side, then a small step forward and slightly rotate the body. Hold this position for 30 sec in 3 sets for 3 days a week.
Category
Treatment - Other

2

Description
Intervention group 2: Pectoralis minor stretch with myofascial release alongwith hot pack. Myofascial release technique can be applied to the subject manually or by myofascial gun for 90 sec thrice a week. Pectoralis minor stretch will applied instantly after MFR.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Pakistan Sports Board and Coaching Centre (PSB)
Full name of responsible person
Iraj Athar
Street address
Ferozepur Rd, Block E 2 Gulberg III, Lahore, Punjab
City
Lahore
Postal code
54810
Phone
+92 42 99230383
Email
info@psb.gov.pk
Web page address
http://www.sports.gov.pk/Detail/ODNmZDljYTMtNmIyOS00YzU3LWFhNmMtZjcxNGM5NjI4NzZm

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Halima Shoukat
Street address
28-M, Quaid-e Azam Industrial Estate, Kot Lakhpat, Lahore
City
Lahore
Postal code
55400
Phone
+92 42 111 747 424
Fax
Email
halima.shoukat@yahoo.com
Web page address
https://www.riphah.edu.pk/lahore
Grant name
Educational
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
Proportion provided by this source
20
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
Full name of responsible person
Iraj Athar
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
8 Shaker road, Ichhra Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
0092
Email
erajathar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah international university, Lahore
Full name of responsible person
Halima Shoukat
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
QIE campus
City
Lahore
Province
Punjab
Postal code
54770
Phone
+92 42 111 747 424
Fax
Email
halima.shoukat@yahoo.com
Web page address
https://www.riphah.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Iraj Athar
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
8-shaker road Ichhra, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
0092
Email
erajathar@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
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
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