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Evaluation of effect of Williams exercises versus Mc kenzie exercises on clinical outcome of patients undergoing lumbar disk herniation surgery

Protocol summary

Study aim
The aim of present study is to investigate the effect of Williams and Mc kenzie exercises on low back pain and abdominal and back muscle endurance in patients with lumbar disc herniation surgery.
Design
Three arm parallel groups randomized trial with not blinded outcome assessment
Settings and conduct
Patients with lumbar disk herniation surgery who operated on Imam Reza Hospital in Kermanshah were included in this study. Patients divided into three groups: group 1( patients with 8 wks of Williams exercises), group 2 patients with 8 weeks of Mc Kenzie exercises) and group 3 (control group). Patient pain, abdominal muscle endurance and lumbar muscle endurance will measure before intervention and eight weeks after intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients between 20 and 50 years old undergoing lumbar disk herniation surgery Exclusion criteria: Age more than 50 years and lower than 20 years Concomitant lumbar canal stenosis and spondylolisthesis.
Intervention groups
The experimental group underwent 8-weeks Williams or Mc Kenzie exercises; whereas the control group received conventional treatment at the same time.
Main outcome variables
Lumbar pain, abdominal muscle endurance, lumbar muscle endurance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190703044089N1
Registration date: 2019-07-25, 1398/05/03
Registration timing: registered_while_recruiting

Last update: 2019-07-25, 1398/05/03
Update count: 0
Registration date
2019-07-25, 1398/05/03
Registrant information
Name
Ehsan Alimohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3523 1333
Email address
hafez125@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of Williams exercises versus Mc kenzie exercises on clinical outcome of patients undergoing lumbar disk herniation surgery
Public title
Effect of Williams Vs Mc Kenzie exercises on clinical outcome of patients undergoing lumbar disk herniation surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 20 and 50 years old undergoing lumbar disk herniation surgery
Exclusion criteria:
Age more than 50 years and lower than 20 years Concomitant lumbar canal stenosis and spondylolisthesis.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
simple Individual randomization. we will use sealed envelops for randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Parastar Ave, Imamreza hospital
City
Kermanshah
Province
Kermanshah
Postal code
6761783365
Approval date
2019-07-03, 1398/04/12
Ethics committee reference number
http://ethics.research.ac.ir/IR.KUMS.REC.1398.294

Health conditions studied

1

Description of health condition studied
Lumbar disk herniation
ICD-10 code
M51.16
ICD-10 code description
Intervertebral disc disorders with radiculopathy, lumbar region

Primary outcomes

1

Description
Pain on the basis of Visual Analog Scale
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Visual analogue scale to measure pain.

Secondary outcomes

1

Description
Abdominal muscle endurance
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Trunk flexion endurance test

2

Description
Back muscle endurance
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Modified Biering-Sorenson test

Intervention groups

1

Description
Intervention group: group 1=patients with Williams exercises
Category
Rehabilitation

2

Description
Intervention group: group 2= patients with Mc kenzie exercises
Category
Rehabilitation

3

Description
Control group: group 3= No intervention
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Ehsan Alimohammadi
Street address
Parastar Ave, Kermanshah, Imam Reza hospital
City
Kermanshah
Province
Kermanshah
Postal code
6761783365
Phone
+98 83 3427 6301
Email
Info@irkh.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Parastar Ave, Imam Reza hospital
City
Kermanshah
Province
Kermanshah
Postal code
6761783365
Phone
+98 83 3427 6301
Email
hafez125@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Kermanshah University of Medical Sciences
Full name of responsible person
Ehsan Alimohammadi
Position
Assistant professor of neurosurgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Parasrar Ave, Imam Reza hospital
City
Kermanshah
Province
Kermanshah
Postal code
6761783365
Phone
+98 83 3427 6301
Email
Info@IRKH.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ehsan Alimohammadi
Position
Assistant professor of neurosurgery
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Kermanshah, Imam Reza hospital, department of neurosurgery
City
Kermanshah
Province
Kermanshah
Postal code
6761783365
Phone
+98 83 3523 1333
Fax
Email
hafez125@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ehsan Alimohammadi
Position
Assistant professor of neurosurgery
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Kermanshah, Imam Reza hospital, department of neurosurgery
City
Kermanshah
Province
Kermanshah
Postal code
6761783365
Phone
+98 83 3523 1333
Fax
Email
hafez125@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected deidentified IPD
When the data will become available and for how long
May 2020
To whom data/document is available
Deidentified IPD will available for people working in academic institutions
Under which criteria data/document could be used
Deidentified IPD and any additional supporting information/documents will be available via contacting with corresponding author.
From where data/document is obtainable
Deidentified IPD and any additional supporting information/documents will be available via contacting with corresponding author.
What processes are involved for a request to access data/document
Deidentified IPD and any additional supporting information/documents will be available via contacting with corresponding author after one month.
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