Protocol summary

Study aim
The objectives of this study are to investigate the effects of the Active Release Technique on correcting scapular dyskinesia, reducing pain, improving shoulder and scapular range of motion, and decreasing functional limitations in patients with repetitive shoulder injuries.
Design
Parallel Group Randomized Controlled Trail
Settings and conduct
Settings: -Allied Hospital Faisalabad -Madina Teaching Hospital, Faisalabad -Mujahid Hospital, Faisalabad Conduct: Single-blinded study (only patient will be blinded of treatment groups)
Participants/Inclusion and exclusion criteria
Inclusion Criteria • Male and females aged 20 to 40 years • Patients who had scapular dyskinesia positive by Modified SAT and LSST • Patient who had pain score of 4 or more on NPRS scale • Patients who had pain, impaired ROM, and functional limitation secondary to repetitive shoulder injuries • Patients who were willing to participate and filled in the informed consent provided by the study protocol Exclusion Criteria • Individuals with significant comorbidities affecting treatment, such as severe cardiovascular disease or neuromuscular disorders, shoulder dislocation, active infection, arthritis, fracture, dislocation/subluxation were excluded • Patient who had neurological injuries such as Long Thoracic Nerve Injury • Patients who had acute shoulder surgeries and winged scapula were excluded due to variations in recovery
Intervention groups
Group A (Interventional Group) will receive active release technique on tight muscles of scapula and baseline treatment Group B (Control Group) will receive only baseline treatment (MWM Scapular Mobilization, Scapular Correction Exercises and Heating modality)
Main outcome variables
Scapular Dyskinesia Pain Range of Motion Functional Limitation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240416061502N1
Registration date: 2024-05-05, 1403/02/16
Registration timing: retrospective

Last update: 2024-05-05, 1403/02/16
Update count: 0
Registration date
2024-05-05, 1403/02/16
Registrant information
Name
Lyba Musaddiq
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 8542452
Email address
2022-ms-pt-028@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-06, 1402/11/17
Expected recruitment end date
2024-04-26, 1403/02/07
Actual recruitment start date
2024-02-12, 1402/11/23
Actual recruitment end date
2024-04-30, 1403/02/11
Trial completion date
2024-04-30, 1403/02/11
Scientific title
EFFECTS OF ACTIVE RELEASE TECHNIQUE ON SCAPULAR DYSKINESIA, PAIN, RANGE OF MOTION AND FUNCTIONAL LIMITATIONS IN PATIENTS WITH REPETITIVE SHOULDER INJURIES
Public title
Active Release Technique on Scapular Dyskinesia in Patients with Repetitive Shoulder Injuries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female aged 20 to 40 years Patients who had scapular dyskinesia positive by Modified SAT and LSST Patients who had pain score of 4 or more on the NPRS scale Patients who had pain, impaired ROM, and functional limitation secondary to repetitive shoulder injuries Patients who were willing to participate and filled the informed consent provided by the study protocol
Exclusion criteria:
Individuals with significant comorbidities affecting treatment, such as severe cardiovascular disease or neuromuscular disorders, shoulder dislocation, active infection, arthritis, fracture, and dislocation/subluxation were excluded Patients who had neurological injury such as Long Thoracic Nerve Injury Patients who had acute shoulder surgeries and winged scapula were excluded due to variations in recovery.
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 24
Actual sample size reached: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Convenient Sampling Randomization/ an Individual unit was assigned to one of the groups/ The tools used were the Chit and Draw method, thoroughly mixed and randomly drawn, the resulting sequence was random. Allocation concealment of participants.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were blinded in my study until the cessation of treatment sessions
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of The University of Faisalabad
Street address
West Canal Road, Faisalabad-37610
City
Faisalabad
Postal code
38000
Approval date
2024-02-17, 1402/11/28
Ethics committee reference number
TUF/DR/SA/MSPP/2024/394

Health conditions studied

1

Description of health condition studied
Scapular Dyskinesia
ICD-10 code
M75.82
ICD-10 code description
Other shoulder lesions, left shoulder

2

Description of health condition studied
Repetitive Shoulder Injuries
ICD-10 code
M75.9
ICD-10 code description
Shoulder lesion, unspecified

Primary outcomes

1

Description
Scapular Dyskinesia
Timepoint
before intervention and at 2 weeks after intervention (6 sessions total)
Method of measurement
Ruler

2

Description
Pain
Timepoint
before intervention and at 2 weeks after intervention (6 sessions total)
Method of measurement
NPRS Scale

3

Description
Shoulder and Scapular Range of Motion
Timepoint
before intervention and at 2 weeks after intervention (6 sessions total)
Method of measurement
Goniometer and Digital Inclinometer

Secondary outcomes

1

Description
Functional Limitation
Timepoint
before intervention and at 2 weeks after intervention (6 sessions total)
Method of measurement
SPADI Questionnaire

Intervention groups

1

Description
Intervention group: Active Release Technique and Baseline Treatment (MWM Mobilization, Scapular Correction Exercises, Heating Modality)
Category
Rehabilitation

2

Description
Control group: Baseline Treatment (MWM Mobilization, Scapular Correction Exercises, Heating Modality)
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Madinah Teaching Hospital
Full name of responsible person
Dr. Kishwar Batool
Street address
25-W-8 Madina Town Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 322 6380789
Email
2022-ms-pt-028@tuf.edu.pk

2

Recruitment center
Name of recruitment center
Allied Hospital
Full name of responsible person
Dr. Mariam Mehmood
Street address
25-W-8 Madina Town Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 322 6380789
Email
2022-ms-pt-028@tuf.edu.pk

3

Recruitment center
Name of recruitment center
Mujahid Hospital, Faisalabad
Full name of responsible person
Dr. Aemen Abid
Street address
25-W-8 Madina Town, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 322 6380789
Email
2022-ms-pt-028@tuf.edu.pk

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Lyba Musaddiq
Street address
25-W-8, Madina Town, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 322 6380789
Email
2022-ms-pt-028@tuf.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Madinah Teaching Hospital
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
The University of Faisalabad, Pakistan
Full name of responsible person
Lyba Musaddiq
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
25-W-8, Madina Town, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 322 6380789
Email
2022-ms-pt-028@tuf.edu.pk

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Faisalabad, Pakistan
Full name of responsible person
Lyba Musaddiq
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
25-W-8, Madina Town, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 322 6380789
Email
2022-ms-pt-028@tuf.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Lyba Musaddiq
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
25-W-8 Madina Town, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 322 6380789
Email
2022-ms-pt-028@tuf.edu.pk

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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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