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A Comparative Study of Maitland Mobilizations and Posterior Pelvic Tilting Exercises on Sciatica

Protocol summary

Study aim
To evaluate the effects of Maitland mobilizations and posterior pelvic tilting exercises on sciatica due to lumbar spondylosis
Design
Single blind, parallel assigned, single centred, randomized clinical trial that will be conducted on 38 participants with diagnosed lumber spondylosis and associated sciatica, and the randomization being accomplished using simple random sampling by means of lottery method
Settings and conduct
DHQ hospital sheikhpura. the participants are kept anonymous for conducting the single-blind trial
Participants/Inclusion and exclusion criteria
Patients aged between 45-60 years, Both males and females, having lumber spondylosis and associated sciatica, lumber disk degeneration, Sciatic pain (Numeric pain rating scale from 3-7), Chronic low back pain, with straight leg raise test(SLR) positive and Confirmed degenerative changes of lumber spine on X-ray, Osteoarthritis of peripheral joints were included in the study. Patients having spondylolisthesis or spondylolysis,Tumors of spine, Spine infection, Ankylosing spondylitis, Severe cases of spinal stenosis, Fractures of spine, Having any spinal surgery, Bone conditions like osteoporosis, Osteomalacia, Blood coagulation defects, Cervical myelopathy , co morbidities like diabetes, hepatitis, Autoimmune disorders, Gout, Any neurological deficit other than sciatic, Referred visceral pain and pregnant females were excluded from the study
Intervention groups
Group A : Participants will receive therapeutic ultrasound over low back area then Maitland mobilizations over affected vertebrae of Lumber spine and posterior pelvic tilting exercises.Group B: Participants will receive therapeutic ultrasound over low back and posterior pelvic tilting exercises
Main outcome variables
sciatic pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210813052170N1
Registration date: 2021-09-12, 1400/06/21
Registration timing: retrospective

Last update: 2021-09-12, 1400/06/21
Update count: 0
Registration date
2021-09-12, 1400/06/21
Registrant information
Name
Sania Iqbal
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 8868326
Email address
saniaiqbal130@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-25, 1400/03/04
Expected recruitment end date
2021-08-05, 1400/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study of Maitland Mobilizations and Posterior Pelvic Tilting Exercises on Sciatica
Public title
Effect of Maitland Mobilizations on Sciatica
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged between 45-60 years Both males and females Patients of lumber spondylosis and associated sciatica Patients of lumber disk degeneration(bulging,protrusion) Sciatic pain (NPRS from 3-7) Chronic low back pain (pain persisting for more than 3 months) SLR positive Confirmed degenerative changes of lumber spine on X-ray Osteoarthritis of peripheral joints
Exclusion criteria:
Patients having spondylolisthesis or spondylolysis Tumors of spine Spine infected cases Patients of ankylosing spondylitis Severe cases of spinal stenosis Fractures of spine Patient having any spinal surgery Pregnant females Bone conditions like osteoporosis, osteomalacia Blood coagulation defects Cervical myelopathy Patients with co morbidities like diabetes, hepatitis Patients with autoimmune disorders like rheumatoid arthritis Gout Patients with any neurological deficit other than sciatica Patients with referred visceral pain
Age
From 45 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 38
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization of the participants was accomplished by using the simple random sampling. For the random allocation of the participants into groups, lottery method will be used, where the participants has equal chances of getting enrolled into any of the two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants will not be aware of the study groups and this will be accomplished 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 Committe of The University of Faisalabad
Street address
University town, Sargodha road Faisalabad
City
Faisalabad
Postal code
38000
Approval date
2021-05-25, 1400/03/04
Ethics committee reference number
TUF/DR/SA/MSPP/2021/213-230

Health conditions studied

1

Description of health condition studied
sciatica associated with lumber spondylosis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
sciatica
Timepoint
before intervention, after 2 weeks of intervention and after 4 weeks of intervention
Method of measurement
Visual analogue scale( VAS), straight leg raise ( SLR)

Secondary outcomes

1

Description
Lumber disability
Timepoint
before intervention and 2 weeks and 4 weeks after intervention
Method of measurement
Roland-Morris disability questionnaire

Intervention groups

1

Description
Intervention group: Group A ( Maitland Mobilizations combined with Posterior Pelvic Tilting Exercises)
Category
Treatment - Other

2

Description
Control group: Group B ( Posterior Pelvic Tilting Exercises)
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
DHQ Hospital Sheikhpura
Full name of responsible person
Dr. Muhammad Azhar Ameen
Street address
Main Sargodha road, Sheikhpura
City
Sheikhpura
Postal code
39350
Phone
+92 56 9200231
Email
info@dhqskp.punjab.gov.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
Faisalabad
Postal code
38000
Phone
+92 41 8785675
Email
osamaramzan@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Sania Iqbal
Position
physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
chak no.154 Teh Chak Jhumra
City
Chak Jhumra
Province
Punjab
Postal code
37700
Phone
+92 41 8868326
Email
Saniaiqbal130@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Sania Iqbal
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Chak no.154 Teh Chak Jhumra
City
Chak Jhumra
Province
Punjab
Postal code
37700
Phone
+92 41 8868326
Email
Saniaiqbal130@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Sania Iqbal
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Chak no.154 Teh Chak Jhumra
City
Chak Jhumra
Province
Punjab
Postal code
37700
Phone
+92 41 8868326
Email
Saniaiqbal130@gmail.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
As we have signed and assured the participants that there data will not be shared any where else other than current 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 furthur 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 everyone regarding field
Under which criteria data/document could be used
Whoever will request for the data
From where data/document is obtainable
Through Email adress Saniaiqbal130@gmail.com
What processes are involved for a request to access data/document
An Email stating the use of data will be appreciated
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