Protocol summary

Study aim
To evaluate the effects of cervical manipulation on posture related cervicogenic headache.
Design
single blind, parallel assigned, multi-centered, randomized clinical trials will be conducted on 36 participants (two groups with 18 participants each) with history of posture related cervicogenic headache.
Settings and conduct
DHQ Gujranwala / Med care international hospital Gujranwala participant kept anonymous for conducting the single blind trial.
Participants/Inclusion and exclusion criteria
Male and female participants of age 20 to 40 years with primary complaint of headache. Frequency of at least once a week from minimum of last 3 months and Minimum Neck Disability Index (NDI) disability score of 20 % or greater. joint tenderness exhibited in at least one of the three upper cervical joints (C0-C3) on assessing through manual palpation, non-throbbing and non-lancinating pain of moderate to severe intensity were included into the study. Excluded Having any other primary headaches e.g. migraine or tension headaches, presence of contraindications to cervical spinal manipulation, metabolic diseases, infection, dislocation, osteoporosis, anticoagulant user, chronic corticosteroid user, previous 3 months history of head or neck surgery, previous history of a whiplash injury within six weeks, bilateral headaches, cervical spine stenosis bilateral upper limb symptoms, exhibiting “5 D’s” & “3 N’s” signs and positive and cervical instability tests were excluded from the study. Patient using analgesic drugs.
Intervention groups
Group A:The baseline treatment will be 20 minutes of hot pack application and neck isometrics with additional treatment of cervical manipulation. Group B: only received baseline treatment 20 minutes of hot pack + neck isometrics will be performed.
Main outcome variables
cervicogenic headache ( pain) Functional disability Quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210813052160N1
Registration date: 2021-08-22, 1400/05/31
Registration timing: registered_while_recruiting

Last update: 2021-08-22, 1400/05/31
Update count: 0
Registration date
2021-08-22, 1400/05/31
Registrant information
Name
Saba Riaz
Name of organization / entity
Sial hospital
Country
Pakistan
Phone
+92 55 6706678
Email address
sabariaz458@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-21, 1400/02/31
Expected recruitment end date
2021-08-28, 1400/06/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cervical manipulation in posture related cervicogenic headache
Public title
Effect of cervical manipulation in posture related cervicogenic headache due to use of electronic media in COVID -19.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female participants participants of ages between 20-40 years participants with primary complaint of headache Frequency of at least once a week from minimum of last 3 months and Minimum Neck Disability Index (NDI) disability score of 20 % or greater participants eligible after being diagnosed cervicogenic headache using revised diagnostic criteria established by the Cervicogenic Headache International Study Group (CHISG) joint tenderness exhibited in at least one of the three upper cervical joints (C0-C3) on assessing through manual palpation non-throbbing non-lancinating pain of moderate to severe intensity were included into the study.
Exclusion criteria:
Participants having any other primary headaches e.g. migraine or tension headaches presence of contraindications to cervical spinal manipulation like tumor, pregnancy, rheumatoid arthritis, fracture, metabolic diseases, infection, dislocation, osteoporosis anticoagulant user, chronic corticosteroid user previous 3 months history of head or neck surgery previous history of a whiplash injury within six weeks bilateral headaches cervical spine stenosis bilateral upper limb symptoms presence of any signs showing central nervous system (CNS) involvement, presence of 2 or more nerve root compression signs, exhibiting “5 D’s” & “3 N’s
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is being accomplished using simple random sampling by mean of lottery method
Blinding (investigator's opinion)
Single blinded
Blinding description
The participant will not be aware of the study groups and this will be carried out by keeping them anonymous for the study period
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics and Technical committee of The University of Faislabad
Street address
university Town, Sargodha Road
City
Faislabad
Postal code
38000
Approval date
2021-05-21, 1400/02/31
Ethics committee reference number
TUF/DR/SA/MSPP/2021/213-230

Health conditions studied

1

Description of health condition studied
Cervicogenic headache
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
cervicogenic headache
Timepoint
Before intervention, 2nd and 4th week
Method of measurement
Numerical Pain Rating Scale

Secondary outcomes

1

Description
Functional Disability
Timepoint
Before intervention and 4th week
Method of measurement
Neck Disability Index

2

Description
Quality of life
Timepoint
Before intervention and 4th week
Method of measurement
Headache Impact Test -6

Intervention groups

1

Description
Intervention Group A: The participants will receive baseline treatment of hot -pack plus neck isometrics with additional treatment of Cervical manipulation.
Category
Treatment - Other

2

Description
Control group B: The participants will receive only base line treatment (20 mints of hot pack and neck isometrics)
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
District headquarter Hospital Gujranwala
Full name of responsible person
Adeel -ul- Rehman
Street address
DHQ Hospital, Hospital Rd, Civil Lines, Gujranwala
City
Gujranwala
Postal code
52250
Phone
+92 55 9200110
Email
rehmanadeel484@gmail.com
Web page address
https://punjab.gov.pk

2

Recruitment center
Name of recruitment center
Med care international Hospital
Full name of responsible person
Akhtar Hunjra
Street address
Med care international Hospital Gill Rd, civil Lines, Gujranwala
City
Gujranwala
Postal code
52250
Phone
+92 55 3732032
Email
drakhtarhunjra@gmail.com
Web page address
https://instacare.pk

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasmin physiotherapy center
Full name of responsible person
Osama Ramzan
Street address
Sargodha Road ,Near Muslim town 3 opposite KIA motors
City
Faislabad
Postal code
38000
Phone
+92 41 8785675
Email
osamaramzan@gmail.com
Web page address
http://omiphysio.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yasmin physiotherapy center
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Sial hospital
Full name of responsible person
Saba Riaz
Position
clinical physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Hunjra house verpal chattha,tehsil Wazirabad,District ,Gujranwala
City
Gujranwala
Province
Punjab
Postal code
52080
Phone
+92 55 6706678
Fax
Email
sabariaz458@gmail.com
Web page address
https://www.marham.pk/hospitals/gujranwala/sial-hospital/ali-pur-chattha

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sial hospital
Full name of responsible person
Saba Riaz
Position
clinical physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Hunjra house verpal chattha,tehsil Wazirabad,District ,Gujranwala
City
Gujranwala
Province
Punjab
Postal code
52080
Phone
+92 55 6706678
Fax
Email
sabariaz458@gmail.com
Web page address
https://www.marham.pk/hospitals/gujranwala/sial-hospital/ali-pur-chattha

Person responsible for updating data

Contact
Name of organization / entity
Sial hospital
Full name of responsible person
Saba Riaz
Position
clinical physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Hunjra house verpal chattha,tehsil Wazirabad,District ,Gujranwala
City
Gujranwala
Province
Punjab
Postal code
52080
Phone
+92 55 6706678
Fax
Email
sabariaz458@gmail.com
Web page address
https://www.marham.pk/hospitals/gujranwala/sial-hospital/ali-pur-chattha

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
As we have signed and assured the participants that there data will not be shared any where else other than study
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The primary and secondary outcome measure data will be shared and no further details regarding patients personal information will be provided.
When the data will become available and for how long
Starting in January 2022
To whom data/document is available
For every one regarding field
Under which criteria data/document could be used
Whoever will request for data
From where data/document is obtainable
Through Email adress
What processes are involved for a request to access data/document
An email starting the use of data will be appreciated
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