Protocol summary

Study aim
To determine the effects of muscle energy technique with and without functional task training on pain and disability in sacroiliac joint dysfunction.
Design
The study will be randomized clinical trial
Settings and conduct
• Boston physiotherapy and wellness clinic,lahore • Fatima Memorial Hospital Shadman Lahore.
Participants/Inclusion and exclusion criteria
Total forty 40 patients will be recruited in the study. The subjects will be randomly assigned to two groups A &B with each containing 20 subjects according to their number in computer generated table. INCLUSION CRITERIA: 1. Subjects between 18 to 35 year of age 2. Subjects with history of recurrent LBP . 3. At least three out of five tests must be positive. 4. Pain at the fortin area EXCLUSION CRITERIA: 1. Patients with radiating pain past the knee. 2. Lumbar disc herniation 3. Spinal deformities 4. Any spinal surgery history
Intervention groups
Total forty subjects will be recruited which will be divided into two groups. Group A will be treated with muscle energy technique (METs) while Group B will receive functional task training along with METs.
Main outcome variables
Pain(Numeric Pain Rating Scale.) Function(Modified oswestry disability index) .

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191009045045N1
Registration date: 2020-05-23, 1399/03/03
Registration timing: prospective

Last update: 2020-05-23, 1399/03/03
Update count: 0
Registration date
2020-05-23, 1399/03/03
Registrant information
Name
SUMAIRA PERVEEN
Name of organization / entity
Riphah international university ,Lahore
Country
Pakistan
Phone
+92 42 27577009
Email address
sumairach25fpur@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-01, 1399/03/12
Expected recruitment end date
2020-08-01, 1399/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
“Effects of muscle energy technique with and without functional task training on pain and disability in sacroiliac joint dysfunction”
Public title
“Effects of muscle energy technique with and without functional task training on pain and disability in sacroiliac joint dysfunction”
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects between 18 to 35 year of age Subjects with history of recurrent LBP At least three out of five tests must be positive. Pain at the fortin area
Exclusion criteria:
Patients with radiating pain past the knee. Lumbar disc herniation Spinal deformities Any spinal surgery history
Age
From 18 years old to 35 years old
Gender
Both
Phase
2
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly assigned to two groups A &B with each containing 20 subjects according to their number in computer generated table.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is single blinded. The data analyzer after the research will be remain blinded
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
BASR (Board of Advanced Studies and Research)
Street address
Ripha international university,QIE campus,mader- millet road Lahore.
City
lahore
Postal code
54000
Approval date
2019-09-26, 1398/07/04
Ethics committee reference number
REC/RCRS/20/1013

Health conditions studied

1

Description of health condition studied
sacroiliac joint dysfunction
ICD-10 code
M99.04
ICD-10 code description
sacroiliac joint dysfunction

Primary outcomes

1

Description
Pain
Timepoint
Evaluation will be done before treatment after one week, at second week and at the end of third week
Method of measurement
Numeric Pain Rating Scale.(NPRS)

2

Description
Function
Timepoint
Evaluation will be done before treatment after one week, at second week and at the end of third week
Method of measurement
Modified oswestry disability index (MODI).

Secondary outcomes

empty

Intervention groups

1

Description
Control group: will be treated with muscle energy technique (METs)
Category
Rehabilitation

2

Description
Intervention group: will receive functional task training along with METs.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
• Boston physiotherapy and wellness clinic,Lahore
Full name of responsible person
DR. Fareeha shah
Street address
bilal street,new garden town lahore
City
Lahore
Postal code
54000
Phone
+92 42 27577009
Email
sumaira25fpur@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ripha international university ,lahore
Full name of responsible person
dr. salman bashir
Street address
RiphaH international University,Lahore
City
Lahore
Postal code
54000
Phone
+92 42 24497959
Fax
+92 42 24497959
Email
salman.bashir@ripha.edu.pk
Web page address
https://www.lahore.riphah.edu.pk/
Grant name
student
Grant code / Reference number
N/A
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
academic support only
Proportion provided by this source
5
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Boston physiotherapy and wellness clinic Lahore
Full name of responsible person
Sumaira perveen
Position
senior physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
garden town,lahore
City
lahore
Province
punjab
Postal code
54000
Phone
+92 42 27577009
Fax
+92 42 27577009
Email
sumairach25four@gmail.com
Web page address
https://oladoc.com/pakistan/lahore/h/boston-physiotherapy-and-wellness-clinic/4955

Person responsible for scientific inquiries

Contact
Name of organization / entity
Boston physiotherapy and wellness clinic,lahore
Full name of responsible person
Sumaira perveen
Position
senior physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
garden town,lahore
City
lahore
Province
punjab
Postal code
54000
Phone
+92 42 27577009
Fax
+92 42 27577009
Email
sumairach25four@gmail.com
Web page address
https://oladoc.com/pakistan/lahore/h/boston-physiotherapy-and-wellness-clinic/4955

Person responsible for updating data

Contact
Name of organization / entity
Boston physiotherapy and wellness clinic,lahore
Full name of responsible person
Sumaira Perveen
Position
senior physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
garden town,lahore
City
lahore
Province
punjab
Postal code
54000
Phone
+92 42 27577009
Fax
+92 42 27577009
Email
sumairach25fpur@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
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
Title and more details about the data/document
Effects of muscle energy technique with and without functional task training on pain and disability in sacroiliac joint dysfunction”
When the data will become available and for how long
it will be available after study completion
To whom data/document is available
to researcher for study only.patient data will not be shown
Under which criteria data/document could be used
under the usage with terms in which journal is accessed /processed for publication
From where data/document is obtainable
from the University office and Responsible supervisor and from journal we will process in future
What processes are involved for a request to access data/document
It will be only used in confidential way for improving research and benefit of humanity
Comments
no comment
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