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Effects of Myofascial Release technique in combination with Cognitive Behavior Therapy on Pain, Craniovertebral Angle and Neck Disability in university students with chronic neck pain and Forward Head Posture

Protocol summary

Study aim
The aim of study will be to compare the effects of Myofascial release technique with Cognitive Behavior Therapy on Pain, Craniovertebral angle, Neck Disability in university students with chronic neck pain and forward head posture
Design
Parallel group randomized clinical trial and Randomization will be achieved through computer generated random number table.
Settings and conduct
Safi Hospital. It will be assessor who will be blinded about the type of intervention. Treatment will be given by principal /investigator
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age group: 18-28 Years, Gender Group: Both male and female participants, Individuals with Craniovertebral angle <53, Individuals having grade 2 neck pain according to KNGF Guidelines. Exclusion Criteria: Past history of shoulder and spine surgery, Congenital problems, Fibromyalgia, Myopathy, Cervical Radiculopathy, Trigger point injections, Any recent accidents
Intervention groups
Interventional Group: (Group A) will receive a hot pack for 5 minutes, followed by a 10-minute myofascial release technique. After that, they will perform isometric exercises consisting of six movements, holding each movement for 10 seconds, repeating every five times with a 5-second rest between them. Cognitive behavior therapy will be administered for 20 minutes, utilizing visual aids in the form of videos, images, animations, simple pamphlets, and text. Control Group: (Group B) will receive a hot pack for 5 minutes, followed by a 10-minute myofascial release technique. After that, they will perform isometric exercises consisting of six movements, holding each movement for 10 seconds, repeating every five times with a 5-second rest between them. Then, the patients will be provided with a Reference Guide on Ergonomics and Design, which they will read for 20 minutes.
Main outcome variables
Pain Craniovertebral angle Neck disability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230216057434N2
Registration date: 2023-03-13, 1401/12/22
Registration timing: registered_while_recruiting

Last update: 2023-03-13, 1401/12/22
Update count: 0
Registration date
2023-03-13, 1401/12/22
Registrant information
Name
Zainab Sheraz
Name of organization / entity
Riphah International University, Faisalabad
Country
Pakistan
Phone
+92 301 7070941
Email address
zainab.48@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-04, 1401/12/13
Expected recruitment end date
2023-05-01, 1402/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Myofascial Release technique in combination with Cognitive Behavior Therapy on Pain, Craniovertebral Angle and Neck Disability in university students with chronic neck pain and Forward Head Posture
Public title
Effect of Cognitive behavior therapy on Chronic neck pain with forward head posture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 18-28 Years Gender: Both male and female participants Individuals with Craniovertebral angle <53 Individuals having grade 2 neck pain according to KNGF Guidelines.
Exclusion criteria:
Past history of shoulder and spine surgery Congenital problems Fibromyalgia Myopathy Cervical Radiculopathy Trigger point injections Any recent accidents
Age
From 18 years old to 28 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done through a computer software "Random allocation". The total sample size will be entered with requirement to be allocated in two groups. An automated randomization list will be achieved with attrition rate included.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding will be done on part of outcome assessor who will be an experienced therapist. Patients will be assessed by him at the end of treatment session. He will be blinded about the type of intervention patient will recieve
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Riphah International University Faisalabad
Street address
Riphah International University, Faisalabad
City
Faisalabad
Postal code
38000
Approval date
2023-01-27, 1401/11/07
Ethics committee reference number
RCRAHS/REC/23/07

Health conditions studied

1

Description of health condition studied
Chronic neck pain
ICD-10 code
M54.2
ICD-10 code description
Cervicalgia

Primary outcomes

1

Description
Pain
Timepoint
Assessment will be performed at 0 week (baseline), at 4th week and at completion of 8 weeks treatment
Method of measurement
Numeric pain rating scale

Secondary outcomes

1

Description
Craniovertebral angle
Timepoint
Assessment will be performed at 0 week (baseline), at 4th week and at completion of 8 weeks treatment
Method of measurement
Photogrammetric method

2

Description
Neck disability
Timepoint
Assessment will be performed at 0 week (baseline), at 4th week and at completion of 8 weeks treatment
Method of measurement
Neck Disability Index (NDI)

Intervention groups

1

Description
Intervention group: Group A (Isometric exercises with myofascial release technique in combination with CBT)
Category
Treatment - Other

2

Description
Control group: Group B (Isometric exercises with myofascial release technique alone)
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Safi Teaching Hospital, Faisalabad, Pakistan
Full name of responsible person
Usama Farooq
Street address
Safi Teaching Hospital , Near Fish Farm, Satyana Road, Faisalabad
City
English
Postal code
38000
Phone
+92 332 5380333
Email
usamafarooqreal@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Self funded
Full name of responsible person
Zainab Sheraz
Street address
House no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 335 6600141
Email
zainab.48@hotmail.com
Grant name
N/A
Grant code / Reference number
N/A
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
N/A
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
Riphah International University, Faisalabad
Full name of responsible person
Zainab Sheraz
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 335 6600141
Email
zainab.48@hotmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah International University, Faisalabad
Full name of responsible person
Zainab Sheraz
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 335 6600141
Email
zainab.48@hotmail.com

Person responsible for updating data

Contact
Name of organization / entity
Riphah International University, Faisalabad
Full name of responsible person
Zainab Sheraz
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 335 6600141
Email
zainab.48@hotmail.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
Real patient is involved
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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