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Effects Of Shoulder Exercises With And Without Cervical Exercises On Pain And Function In The Patients With Cervical Spondylosis: Randomized Controlled Trail

Protocol summary

Study aim
To compare the combine effect of cervical isometric with shoulder isometric exercises on pain, function and forward head posture in patients with cervical spondylosis. To find the correlation of factors affecting on pain, function and their management in the patients with cervical spondylosis
Design
A community based, single blind, parallel group, randomized controlled trial
Settings and conduct
Study conducted in Water and Power Development Authority teaching Hospital Lahore the trial is single blind, the participants and data analyzed were blinded they did not know, they belong to which group either experimental and control group
Participants/Inclusion and exclusion criteria
Both male and female, 30-60 years, Diagnosed patients by orthopedic surgeons, No previous surgical /steroidal history in last six months, Patients having symptoms of radiculopathy Exclusion Criteria: Pregnant women, History of previous cervical surgery, Vertebral compression fracture, History of malignancy, Rheumatoid disorder and other systemic problems, Any infectious disease like osteomyelitis, tuberculosis, ankylosing spondylitis etc.
Intervention groups
Group A (experimental) was received cervical isometric exercises with shoulder isometric exercises. Group B (control) was received cervical isometric exercises without shoulder isometric exercises.
Main outcome variables
Compare the combine effect of cervical isometric with shoulder isometric exercises on pain, function and forward head posture and correlation with factors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230521058241N1
Registration date: 2023-06-06, 1402/03/16
Registration timing: retrospective

Last update: 2023-06-06, 1402/03/16
Update count: 0
Registration date
2023-06-06, 1402/03/16
Registrant information
Name
anam ashfaq
Name of organization / entity
University of lahore
Country
Pakistan
Phone
+92 307 0146280
Email address
anam.ashfaq9242@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-01, 1400/09/10
Expected recruitment end date
2022-06-02, 1401/03/12
Actual recruitment start date
2022-01-04, 1400/10/14
Actual recruitment end date
2022-08-24, 1401/06/02
Trial completion date
2022-11-18, 1401/08/27
Scientific title
Effects Of Shoulder Exercises With And Without Cervical Exercises On Pain And Function In The Patients With Cervical Spondylosis: Randomized Controlled Trail
Public title
Correlation of factors that affect on pain and functional status and their management in cervical spondylosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both male and female Aged 30-60 year No pervious history of trauma Surgery and diagnosed patients by orthopedic
Exclusion criteria:
Pregnant women History of previous cervical surgery Vertebral compression fracture History of malignancy Rheumatoid disorder and other Systemic problems, any infectious disease like Osteomyelitis, Tuberculosis, Ankylosing spondylitis
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
Sample size
Target sample size: 70
Actual sample size reached: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by lottery method was carried out for allocation of participants into groups
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants, Care giver and Data analyzer was blind in current study, they did not know they belong to which group either to experimental and control
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical commitee of the University of Lahore
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Postal code
54590
Approval date
2022-04-28, 1401/02/08
Ethics committee reference number
REC/UOL/149

Health conditions studied

1

Description of health condition studied
Cervical spondylosis
ICD-10 code
M47.812
ICD-10 code description
Spondylosis without myelopathy or radiculopathy, cervical region

Primary outcomes

1

Description
To compare the combine effect of cervical isometric with shoulder isometric exercises on pain in patients with cervical spondylosis.
Timepoint
Primary outcomes measure at baseline at 3th and 6th week
Method of measurement
Pain by Visual Analog Scale (VAS)

2

Description
To compare the combine effect of cervical isometric with shoulder isometric exercises on function in patients with cervical spondylosis.
Timepoint
Primary outcomes measure at baseline at 3th and 6th week
Method of measurement
Participants was complete Neck Pain Disability Index Questionnaire for function level

3

Description
Forward head posture
Timepoint
Primary outcomes measure at baseline at 3th and 6th week
Method of measurement
Forward head posture was measured by caranio- vertebral angle.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group A was received cervical isometric exercises with shoulder isometric exercises
Category
Rehabilitation

2

Description
Control group: Group B was received cervical isometric exercises without shoulder isometric exercises
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
WAPDA Teaching Hospital Lahore
Full name of responsible person
Dr. Abid Javaid Minhas
Street address
210 Lahore – Kasur Rd, near Rehmanpura Colony, Lahore, Punjab 54000
City
Lahore
Postal code
54000
Phone
+92 42 37590711
Email
abidminhas.pt@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Dr. Ashfaq Ahmad
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Postal code
54590
Phone
+92 42 111 865 865
Email
ashfaq.ahmad@uipt.uol.edu.pk
Grant name
Anam Ashfaq
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
SELF
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Anam Ashfaq
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
837-838-block R1 Johar Town Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 307 0146280
Email
anam.ashfaq9242@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University Of Lahore
Full name of responsible person
Anam Ashfaq
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
837-838-block R1 Johar Town Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 307 0146280
Email
anam.ashfaq9242@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Anam Ashfaq
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
837-838-block R1 Johar Town Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 307 0146280
Email
anam.ashfaq9242@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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