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Effectiveness of Routine Physical Therapy with and without Core Stability Exercises in Patients with Rotator Cuff Tendinopathy.

Protocol summary

Study aim
The aim of the study is to describe the importance of core stability's association with efficient mobility of extremities needs to be included in Rotator Cuff tendinopathy rehabilitation, along with conventional measures.
Design
Randomized controlled, single blinded clinical trial. The treatment have either superior, parallel effects to the control group. Single centered
Settings and conduct
Water and Power Development Authority Teaching Hospital Complex, physical therapy department. Patients who fulfil the above mentioned criteria were identified by individual physiotherapist and then enrolled in particular study group. Informed written consent was taken by the patients and was randomly allocated by using the lottery method to two groups. The total number of sessions was 12 and duration of the treatment was 4 weeks. The study was single blinded. The assessor was unaware of the treatment given to both groups.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Diagnosed rotator cuff tendinopathy patients. Both genders were included. Age: 25-50 years. Exclusion Criteria: Any deformity of upper, lower extremity and spine. Any surgery of shoulder and spine. Tumor. Trauma and fracture. Cervical Radiculopathy.
Intervention groups
Experimental group: therapeutic ultrasound (Frequency: 1.1MHz, Intensity: 1.5 W/cm2 ), stretching and strengthening exercise of cervical and shoulder and Core Stability exercises. Duration: 45-60 minutes, 3 times a week, 3 sets, 10-15 repetitions with 10 seconds hold. Control group: therapeutic ultrasound (Frequency: 1.1MHz, Intensity: 1.5 W/cm2 ), stretching and strengthening exercise of cervical and shoulder. Duration: 45-60 minutes, 3 times a week, 3 sets, 10-15 repetitions with 10 seconds hold.
Main outcome variables
Visual analogue scale (VAS) Comparative pain scale chart. Shoulder pain and disability index (SPADI) Range of motion

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210118050074N1
Registration date: 2022-01-11, 1400/10/21
Registration timing: retrospective

Last update: 2022-01-11, 1400/10/21
Update count: 0
Registration date
2022-01-11, 1400/10/21
Registrant information
Name
Mahrukh Asghar
Name of organization / entity
University of the Lahore
Country
Pakistan
Phone
+92 42 35968450
Email address
mahrukhasghar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-10-30, 1399/08/09
Actual recruitment start date
2020-02-05, 1398/11/16
Actual recruitment end date
2020-12-30, 1399/10/10
Trial completion date
2021-03-27, 1400/01/07
Scientific title
Effectiveness of Routine Physical Therapy with and without Core Stability Exercises in Patients with Rotator Cuff Tendinopathy.
Public title
Core Stability exercises for Rotator cuff Tendinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed patients with rotator cuff tendinopathy
Exclusion criteria:
Any deformity of upper extremity, lower extremity and spine Any surgery of shoulder and spine Tumor Any traumatic injury and fracture Cervical radiculopathy
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: 54
Actual sample size reached: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization of individuals. All the individuals were allocated in two groups, odd numbers were given to group A (Experimental) and even numbers were given to group B (Control). Sealed enveloped method was used for randomization by using Sobolsoft software. Allocation concealment was carried out by Sequentially numbered, opaque, sealed envelope (SNOSE) technique.
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessor was blinded by simply not informing. The assessor after assessment handed over the envelop to the patient and then patient handed over the envelop to the therapist.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
University of Lahore, Institutional review board
Street address
1 KM Defense road, Off bhobatian chowk, Lahore
City
Lahore
Postal code
54000
Approval date
2020-03-06, 1398/12/16
Ethics committee reference number
IRB-UOL-FAHS/718-XX/2020

Health conditions studied

1

Description of health condition studied
Rotator cuff tendinopathy
ICD-10 code
M75.102
ICD-10 code description
Unspecified rotator cuff tear or rupture of left shoulder, not specified as traumatic

Primary outcomes

1

Description
Pain
Timepoint
Before intervention, 4 weeks, at 6th session and 12th session
Method of measurement
Visual analogue scale

2

Description
Range of Motion
Timepoint
Before intervention, 4 weeks, at 6th session and 12th session
Method of measurement
Universal goniometer

3

Description
Functional status
Timepoint
Before intervention, 4 weeks, at 6th session and 12th session
Method of measurement
Shoulder pain and disability index (SPADI)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group received routine physical therapy and core stability exercises. This includes patient education, therapeutic ultrasound, stretching and strengthening exercises. Shoulder exercises; Range of Motion, pendulum exercises, stretching exercises of shoulder and cervical, core stability exercises. Duration: 45 minutes approx., Frequency: 3 times a week, Sets: 3sets, Repetition: 10-15 repetitions, Hold: 10 sec.
Category
Rehabilitation

2

Description
Control group received only routine physical therapy; includes patient education, therapeutic ultrasound, stretching and strengthening exercises. Shoulder exercises; Range of Motion, pendulum exercises, stretching exercises of shoulder and cervical. Duration: 45 minutes approximately. Frequency: 3 times a week. Sets: 3 sets. Repetition: 10-15 repetitions. Hold: 10 second.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Water and Power Development Authority Teaching Hospital Complex
Full name of responsible person
Dr. Abid Javed Minhas
Street address
210- Ferozepur road Lahore.
City
Lahore
Postal code
54000
Phone
+92 42 37590711
Email
abidmminhas.pt@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Mahrukh Asghar
Street address
1 KM Defense road, Off bhobatian chowk, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35322501
Email
mahrukhasghar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Lahore
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Mahrukh Asghar
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Ho. No. 738, Block D, 4th Avenue, Sector South-East, Phase 1, NFC Society
City
LAHORE
Province
Punjab
Postal code
54000
Phone
+92 42 35968450
Email
mahrukhasghar@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Mahrukh Asghar
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Ho. No. 738, Block D, 4th Avenue, Sector South-East, Phase 1, NFC Society
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35968450
Email
mahrukhasghar@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Mahrukh Asghar
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Ho. No. 111 Block A-1 PGECHS Phase-1 Near Wapda Town
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35968450
Email
mahrukhasghar@yahoo.com

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
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Abstract.
When the data will become available and for how long
After publication the data will be available for 5 years.
To whom data/document is available
Public and physical therapists.
Under which criteria data/document could be used
Only physical therapists can use the data for research purpose.
From where data/document is obtainable
From personal email.
What processes are involved for a request to access data/document
Steps: 1. provide study plan 2. CV 3. Request letter
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