To compare effects of Janda’s approach with Bruegger’s exercise on clinical outcome in patient with lower cross syndrome.
Design
two arm parallel group randomized trial with single blinded and single center
Settings and conduct
Physiotherapy department of Dr. Khalid Clinic Lahore Pakistan
Participants/Inclusion and exclusion criteria
Participants: The calculated sample size using VAS as outcome measure is 33 in each Group After adding 20% dropout the sample size will be 33+6=39 in each group.
Inclusion criteria:
▪ Both male and females were included in study
▪ Age 19 – 50
▪ Patients having low back pain more than three months
▪ Patients having tight hip flexor (range of motion less than 30 degree)
▪ Patients identified with lower cross syndrome
▪ Samples have sitting duration more than six hours in their daily routine
Exclusion criteria:
▪ Grand multigravida
▪ Pelvic inflammatory disease
▪ Renal impairment
▪ Arthritis
▪ Pregnancy
▪ Sciatica
Intervention groups
In Group-A janda’s approach was applied and in Group-B Bruegger’s exercises was used for treatment.
Main outcome variables
Quality of life
Functional disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220212054003N1
Registration date:2022-04-08, 1401/01/19
Registration timing:registered_while_recruiting
Last update:2022-04-08, 1401/01/19
Update count:0
Registration date
2022-04-08, 1401/01/19
Registrant information
Name
Noor Ul ain
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 321 9447169
Email address
noorulann20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-20, 1400/12/29
Expected recruitment end date
2022-10-15, 1401/07/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of janda's approach and burgger's exercise on clinical outcome in patient with lower cross syndrome: A Randomized control trial.
Public title
Comparative effect of janda's approach and burgger's exercise in patient with lower cross syndrome: A Randomized control trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both male and female are included in studies
Age 19 to 50 years
Patient having low back pain more than three months
Patient having tight hip flexor (range of motion less than 30 degree)
Patient identified with low cross syndrome
Samples having sitting duration more than six hours
Exclusion criteria:
Grand multigravida
Pelvic inflammatory disease
Renal impairment
Arthritis
Sciatica
Pregnancy
Age
From 19 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Non probability purposive sampling technique is used to admit patient into studies there were father randomized by lottery method, each member of the population is assigned a number, then these number were placed in a bowl. the researcher asked the patient to pick one slip than randomly allotted to intervention group A and intervention group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
the assessor was an Orthopedic Doctor who was unaware of patient allotment in group A and B. He will assess patient at baseline and subsequent follow up.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical review committee of University of Lahore
Street address
University of Lahore defense road Lahore
City
Lahore
Postal code
58800
Approval date
2022-04-03, 1401/01/14
Ethics committee reference number
IRB-UOL-FAHS/899-IV/2021
Health conditions studied
1
Description of health condition studied
lower cross syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of life
Timepoint
follow up at 2nd week and 4th week of intervention
Method of measurement
Questionnaire
2
Description
Functional disability
Timepoint
2nd week and 4th week of follow up
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Group-1 was given the treatment via Janda’s Approach Group received sensory motor training (static phase, dynamic phase, functional phase). Duration of the treatment lasted for 30 minutes, each exercise 10 seconds or less than 1 minutes.
Category
Rehabilitation
2
Description
Intervention group 2 : Group 2 received Bruegger’s exercise treatment. Patients were instructed to sit on the edge of the chair with their hips abducted, their feet externally rotated, their heads held up, their forearms supinated, their wrists and digits extended, and to slowly exhale through their lips while actively laterally rotating their arms and spreading their digits. The patient is supposed to do this exercise once or twice every 20-30 minutes and hold the position for 30-60 seconds.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Khalid clinic
Full name of responsible person
Noor ul Ain
Street address
Cavalry Lahore
City
Lahore
Postal code
54000
Phone
+92 321 9447169
Email
noorulann20@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Noor ul ain
Street address
house 597 3c 1 Hashmi street Township Lahore
City
Lahore
Postal code
54770
Phone
+92 321 9447169
Email
noorulann20@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
University of Lahore
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
University of Lahore
Full name of responsible person
Noor ul ain
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House 597 3c1 Township Lahore
City
Lahore
Province
Punjab
Postal code
54770
Phone
+92 321 9447169
Email
noorulann20@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Noor ul ain
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House 597 3c1 Township Lahore
City
Lahore
Province
Punjab
Postal code
54770
Phone
+92 321 9447169
Email
noorulann20@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Noor ul ain
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house 597 3c1 Township Lahore
City
Lahore
Province
Punjab
Postal code
54770
Phone
+92 321 9447169
Email
noorulann20@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available