To compare the effects of Powerball in addition to routine physical therapy on pain, range of
motion and functional disability in patients with scapular dyskinesis
Design
Randomized Controlled Trial; single-blinded; on 44 samples; parallel groups; randomized by computer-generated method and further concealed envelop method used for allocation in the group. In the envelope, 1 will be code for the control group and 2 will be code for the experimental group.
Settings and conduct
The study will be conducted at the Physiotherapy department THQ Khushab. The study will be single-blinded. The assessor will unaware of the treatment given to either group.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Age of 25- 50 years.
Both gender
Pre-Diagnosed cases of scapular dyskinesis
A score of greater than or equal to 4/10 on Numeric Rating Pain Scale (NRPS)
All types of scapular dyskinesis
Exclusion Criteria:
Previous cervical spine or shoulder surgery
Presence of a severe systemic disease (as Systemic lupus erythematous, Sickle
cell disease)
Participation in an exercise program for the scapular or shoulder muscles in the 6
months preceding the study
Severe osteoporosis
Whiplash injury/fracture
Intervention groups
Group B: (Experimental Group)
Group B will receive Powerball intervention along with same conventional physical therapy
as given in group A. 3 sessions will be given on alternate days each week, for next 4 weeks.
5-10 minutes Powerball intervention will be given in each session. The overall treatment
session for this group lasts for 35-40 minutes.
Main outcome variables
pain, range of motion and functional disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210321050752N3
Registration date:2023-03-08, 1401/12/17
Registration timing:registered_while_recruiting
Last update:2023-03-08, 1401/12/17
Update count:0
Registration date
2023-03-08, 1401/12/17
Registrant information
Name
Muhammad Waqas
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 36532841
Email address
drwaqasfayyaz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-07, 1401/09/16
Expected recruitment end date
2023-05-07, 1402/02/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of powerball in addition to routine physical therapy on pain, range of motion and functional disability in scapular dyskinesis
Public title
Effects of powerball on pain, range of motion and functional disability in scapular dyskinesis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 25- 50 years
Both gender
Pre-Diagnosed cases of scapular dyskinesis
A score of greater than or equal to 4/10 on Numeric Rating Pain Scale (NRPS)
All types of scapular dyskinesis
Exclusion criteria:
Previous cervical spine or shoulder surgery
Presence of a severe systemic disease (as Systemic lupus erythematous, Sicklecell disease)
Participation in an exercise program for the scapular or shoulder muscles in the 6months preceding the study
Severe osteoporosis
Whiplash injury/fracture
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomized by using the computer-generated method and further concealed envelop method is used for allocation in the group. In the envelop, 1 will be code for the control group and 2 will be code for the experimental group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Assessor will only assess the patient at baseline and after follow-up for treatment outcomes. Assessor safe the data for follow-up and will not share it with any therapist or patient. At any stage, the assessor is unaware of the treatment and control group. The study was single-blinded. The assessor was unaware of the treatment given to either groups 1 or 2.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The rules and regulations set by the ethical committee of The University of Lahore wIll be followed.
Data will be collected at base line, at 2nd week and at 4th week after intervention
Method of measurement
Numeric pain rating scale to measure pain
2
Description
Functional Disability
Timepoint
Data will be collected at base line, at 2nd week and at 4th week after intervention
Method of measurement
The Shoulder Pain and Disability Index (SPADI)
3
Description
Scapular Range of Motion
Timepoint
Data will be collected at base line, at 2nd week and at 4th week after intervention
Method of measurement
To measure linear distance of scapula, tape is used to measure accurate up to 0.1 cm.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group B: (Experimental Group)Group B will receive Powerball intervention along with same conventional physical therapy as given in group A. 3 sessions will be given on alternate days each week, for next 4 weeks.5-10 minutes Powerball intervention will be given in each session. The overall treatment session for this group lasts for 35-40 minutes.
Category
Rehabilitation
2
Description
Control group: Group A: (Control Group)Group A will receive conventional physical therapy (stretching exercises, mobility and strengthening exercise). Hot pack and Therapeutic ultrasound will be given for 8-10 minutes each in every session. This will be given up to three sessions per week on alternate days.Each session will last for 30 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
THQ Hospital khushab
Full name of responsible person
Shahid Iqbal
Street address
THQ khushab, kushab sakesar road kushab (punjab)
City
Sargodha
Postal code
40600
Phone
+92 302 6039958
Email
shahidiqbalsa8@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Self Supported
Full name of responsible person
Kashaf Faraz
Street address
Rajab house jail road shahpur sadar
City
Sargodha
Postal code
40600
Phone
+92 304 6541357
Email
kashaffraz@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Self Supported
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Muhammad Waqas
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
St# 76, H#09 Muhala Sirajpura Darogawala Shalamar Town Lahore
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
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
Title and more details about the data/document
Numeric pain rating scale will be used for the assessment of pain. Functional disability related data.
When the data will become available and for how long
6 months after publication.
To whom data/document is available
academic and clinical research writers.
Under which criteria data/document could be used
Never without permission.
From where data/document is obtainable
From Muhammad Waqas through mail id. drwaqasfayyaz@gmail.com or through a Researchgate account. https://www.researchgate.net/profile/Muhammad-Waqas-26?ev=hdr_xprf
What processes are involved for a request to access data/document
From Muhammad Waqas through mail id. drwaqasfayyaz@gmail.com or through a Researchgate account. https://www.researchgate.net/profile/Muhammad-Waqas-26?ev=hdr_xprf