randomization will be through lottery method ,single blinded study will be conducted in which only patient would be blinded
Settings and conduct
Tehsil headquater hospital, haroonabad
Participants/Inclusion and exclusion criteria
inclusion: cervical radiculopathy impact scale 10 to 60 included, pain 4 to 8 numeric pain rating scale in neck
exclusion:Rheumatoid arthritis, osteoporosis
Intervention groups
two groups
group A single session
group B multiple session
Main outcome variables
cervical radiculopathy impact scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220203053917N1
Registration date:2022-05-17, 1401/02/27
Registration timing:retrospective
Last update:2022-05-17, 1401/02/27
Update count:0
Registration date
2022-05-17, 1401/02/27
Registrant information
Name
Zeb un nisa
Name of organization / entity
The University of Faislabad
Country
Pakistan
Phone
+92 312 6006078
Email address
dpt-fa13-058@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-20, 1400/12/29
Expected recruitment end date
2022-03-28, 1401/01/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparative effects of single verse multiple sessions of eldoa in patients of cervical radiculopathy
Public title
comparative effects of single verse multiple sessions of eldoa in patients of cervical radiculopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
cervical radiculopathy impact scale 10 to 60
spurling test positive
Exclusion criteria:
diagnosed cases of RA osteoprosis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
randomization is done by lottery method. sealed envelop will made upon which allocation of participants in both groups can be possible without biasness
Blinding (investigator's opinion)
Single blinded
Blinding description
participant is blinded means they dont know what treatment the other group gets
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committe of the university of faisalabad
Street address
bangla road
City
haroonabad
Postal code
52250
Approval date
2022-03-13, 1400/12/22
Ethics committee reference number
1021
Health conditions studied
1
Description of health condition studied
cervical radiculopathy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
total 2 weeks of interventional period in which every week 3 sessions and assessment of pain before and after every session
Method of measurement
numeric pain rating scale
Secondary outcomes
1
Description
quality of life
Timepoint
2 weeks
Method of measurement
cervical radiculopathy impact scale
Intervention groups
1
Description
intervention 1: single session. this group recieve only eldoa for 60 sec in clinic for once and then for 2 weeks telephonic record will be taken. numeric pain rating scale taken pre and post of every session
Category
Rehabilitation
2
Description
Intervention group: 2 multiple session: this group will recieve 3 sessions per week for 2 weeks. eldoa perform in clinic for 5 reps with 5 sec hold. numeric pain rating scale recorded pre and post of every session.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehsil headquater haroonabad
Full name of responsible person
dr nabeel
Street address
bangla road
City
haroonabad
Postal code
52250
Phone
+92 312 6006078
Email
zaibsaeed058@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
the university of faisalabad
Full name of responsible person
dr sidra majeed
Street address
bangla road
City
haroonabad
Postal code
52250
Phone
+92 312 6006078
Email
zaibsaeed058@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
the university of faisalabad
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
PK
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
the university of faisalabad
Full name of responsible person
dr sidra majeed
Position
assistant professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
bangla road
City
haroonabad
Province
punjab
Postal code
52250
Phone
+92 312 6006078
Email
zaibsaeed058@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
the university of faisalabad
Full name of responsible person
dr sidra majeed
Position
assistant professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
bangla road
City
haroonabad
Province
punjab
Postal code
52250
Phone
+92 312 6006078
Email
zaibsaeed058@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
zainab medicare hospital
Full name of responsible person
dr zeb un nisa
Position
clinical physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
bangla road
City
haroonabad
Province
punjab
Postal code
52250
Phone
+92 312 6006078
Email
zaibsaeed058@gmail.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
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
IPD collected for primary and secondary outcome measures
When the data will become available and for how long
jan 2023
To whom data/document is available
people working in any domain can be authorized to get this data
Under which criteria data/document could be used
any wrong information or editorial errors
From where data/document is obtainable
this data is only available on-demand via email mention to the person responsible
What processes are involved for a request to access data/document
documents can also be processed via university emails