Protocol summary

Study aim
Aim of the study to determined exercises management for pain and forward head posture in patient with cervical spondylosis
Design
Randomized control trail study
Settings and conduct
The current study carried out in WAPDA teaching hospital in physical therapy department
Participants/Inclusion and exclusion criteria
The inclusion criteria of study includes both male and female, aged 40-60 year, no pervious history of trauma, surgery and diagnosed patients by orthopedic, pain is not more than 8 at VAS. Pregnant women, Pain is more than 8 at VAS, history of previous cervical surgery, vertebral compression fracture, history of malignancy, rheumatoid disorder and other systemic problems were excluded.
Intervention groups
Group A or Interventional group will received cervical isometric and postural corrected exercises with shoulder dynamics exercises 4 session per week for 6 week. GROUP B or Control group will received cervical isometric and postural corrected exercises 4 session per week for 6 week.
Main outcome variables
Pain and forehead posture

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230124057196N2
Registration date: 2023-12-20, 1402/09/29
Registration timing: retrospective

Last update: 2023-12-20, 1402/09/29
Update count: 0
Registration date
2023-12-20, 1402/09/29
Registrant information
Name
mariam umer hayat
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 321 4437350
Email address
mariamumerhayat@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-11-02, 1402/08/11
Actual recruitment start date
2023-06-19, 1402/03/29
Actual recruitment end date
2023-12-05, 1402/09/14
Trial completion date
2023-12-05, 1402/09/14
Scientific title
Exercises management for pain and forward head posture in patients with cervical spondylosis
Public title
Exercises management for pain and forward head posture in patients with cervical spondylosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both male and female Aged 40-60 year Pain is NOT more than 8 at visual analogous scale (VAS) Diagnosed patients by orthopedic No pervious history of trauma and surgery of cervical spine
Exclusion criteria:
Pregnant women History of previous cervical surgery Pain is more than 8 at visual analogous scale (VAS) vertebral compression fracture Age more than 60 or less than 40 History of malignancy, rheumatoid disorder and other systemic problem
Age
From 40 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: 68
Randomization (investigator's opinion)
Randomized
Randomization description
The participant of study was randomly allocated in experimental and control group by lottery method after recruitment of sample participants
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant, Care provider and Data analyzer did not know which participant belonged to which group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The University of Lahore
Street address
1-Km Defense Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Postal code
54000
Approval date
2023-06-19, 1402/03/29
Ethics committee reference number
REC-UOL-119-06-2023

Health conditions studied

1

Description of health condition studied
Cervical spondylosis
ICD-10 code
M43.02
ICD-10 code description
Spondylolysis, cervical region

Primary outcomes

1

Description
Pain
Timepoint
Measurement of primary outcome before the intervention(baseline) and after intervention at 6th week
Method of measurement
Visual analogue scale

2

Description
Forward head posture
Timepoint
Measurement of primary outcome before the intervention(baseline) and after intervention at 6th week
Method of measurement
Forward head posture measured by carnio vertebral angle by Photogrammetry method

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group received shoulder dynamics exercises with cervical isometric and postural correction exercises for 6 week 4 session per week for 40 min each session in 3 sets with 10sce rest in each set. For shoulder dynamics free weight are used, dumbbell of half kg to 2 kg was used, the progression is made by increasing weight 1 week to 6 week
Category
Rehabilitation

2

Description
Control group: Received cervical isometric and postural correction exercises for 6 week 4 session per week for 40 min each session in 3 sets with 10sce rest in each set. For shoulder dynamics free weight are used, dumbbell of half kg to 2 kg was used, the progression is made by increasing weight 1 week to 6 week
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
WAPDA Teaching Hospital
Full name of responsible person
Dr. Abid Javaid
Street address
210-Ferozpur Road Lahore
City
Lahore
Postal code
54000
Phone
+92 42 37564705
Fax
+92 42 35232285
Email
abidminhas.pt@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Dr. Ashafaq aAhmad
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Postal code
54000
Phone
+92 42 111 865 865
Email
ashfaq.ahmad@uipt.uol.edu.pk
Grant name
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mobility Quest
Full name of responsible person
Mariam Umer Hayat
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
L 103 DHA rahber phase 2 Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 321 4437350
Email
mariamumerhayat@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mobility QUEST
Full name of responsible person
Mariam Umer Hayat
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
L103 DHA rahber phase 2
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 321 4437350
Email
mariamumerhayat@gmai.com

Person responsible for updating data

Contact
Name of organization / entity
Mobility QUEST
Full name of responsible person
Mariam Umer Hayat
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
L103 DHA rahber phase 2 Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 321 4437350
Email
mariamumerhayat@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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