Protocol summary

Study aim
The aim of this study is to compare the effects of positional release technique and ELDOA stretches to imporove hip pain Range of motion and functional mobility in piriformis syndrome patient
Design
Study Design; randomization will be through sealed envelopes method, and blinding will not occur
Settings and conduct
Subjects with piriformis syndrome will be taken from Allied hospital Faisalabad.Blinding: Participants will be blinded they will not be aware whether they are in Group A or Group B as the participants of both groups will be receive 2 step intervention.
Participants/Inclusion and exclusion criteria
Inclusion crieteria is positive fair test. pain in prolong sitting. exclusion criteria inflammatory arthritis
Intervention groups
Two groups. both are treatment group. Group A received positional release technique and group b receives Elongation osteoarticular decopatation stretch
Main outcome variables
Pain , Range of motion and functional mobility.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220601055050N1
Registration date: 2022-08-16, 1401/05/25
Registration timing: retrospective

Last update: 2022-08-16, 1401/05/25
Update count: 0
Registration date
2022-08-16, 1401/05/25
Registrant information
Name
Ilsa waqi Khunsha
Name of organization / entity
The university of faisalabad
Country
Pakistan
Phone
+92 313 0559605
Email address
ilsawaqikhunsha123@gmail.com
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 Positional Release and Elongation Longitudinaux Avec Decoaption Osteo Articulaire (ELDOA) stretches for Hip Joint Range of Motion, Pain and Functional Mobility in Piriformis Syndrome Patients
Public title
Comparative effects of Eldoa in patients with piriformis syndrome to improve functional status and range of motion of hip joint
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
positive Fair test Both Male and Female patients. Pain is increasing with prolonged sitting All participants with in the age group of >30-70 yrs having symptoms of Piriformis Syndrome Patient who are having pain at buttock region or Hip joint involvement.Pain is increasing with prolonged sitting. Pain is increasing with prolonged sitting Patients with both unilateral Or Bilateral Piriformis muscle involvement. Patients who are willing to particiapate in the study.
Exclusion criteria:
Inflammatory Arthritis at involved side. Any known malignancy /neoplasma involved side.. Diagnosed/known psychiatric illness.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Sample will be allocated to Group A (positional Release technique) and Group B (ELDOA stretch) randomly using sealed envelopes. Method of Randomization: Simple Randomization Tool for Randomization: Sealed envelopes Unit of Randomization: Individual
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
The university of Faisalabad
Street address
Sargodha road Faisalabad
City
Faisalabad
Postal code
38000
Approval date
2022-06-02, 1401/03/12
Ethics committee reference number
110456789

Health conditions studied

1

Description of health condition studied
Piriformis muscle pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
pain
Timepoint
total 06 weeks treatment with 03 session per week with 20 min of baseline hot pack
Method of measurement
visual analogue scale

Secondary outcomes

1

Description
functional mobility
Timepoint
06 weeks will be the total time for measuring outcomes . Outcome will be measured after every session . Per week 2 sessions .. for total 4 weeks.
Method of measurement
lower extremity functional mobility scale

Intervention groups

1

Description
group receives positional release technique, 03 repetitions will be applied for total 03 sessions per week for 06 weeks. No electro therapy modalities will be used, with base line treatment which is hot pack also given for 3 sessions per week for 6 weeks .
Category
Rehabilitation

2

Description
group 02 receives ELDOA stretches on hip joints . total sessions are 18, 03 sessions in whole week. With no possible electro therapy modalities, with base line treatment which is hot pack applied for 6 weeks per week 3 sessions on hip joint . Hotpack will b moist heating pad
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Allied hospital Faislabad punjab pakistan
Full name of responsible person
Dr sobia nawaz
Street address
allied morh faisalabad
City
faislabad
Postal code
38000
Phone
+92 304 1171975
Email
ilsawaqikhunsha123@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
muslim town o3 house 327 street 11 sargodha road faisalabad
City
faisalabad
Postal code
38000
Phone
+92 304 1171975
Email
ilsawaqikhunsha123@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
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
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
sargodha road fsd
City
faisalabad
Province
punjab
Postal code
38000
Phone
+92 304 1171975
Email
ilsawaqikhunsha123@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
sargodha road fsd
City
faisalabad
Province
punjab
Postal code
38000
Phone
+92 304 1171975
Email
ilsawaqikhunsha123@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
the university of faisalabad
Full name of responsible person
Ilsa Waqi khunsha
Position
clinical physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
allied morh faisalabad
City
faisalabad
Province
punjab
Postal code
38000
Phone
+92 543 682173
Email
ilsawaqikhunsha123@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
IPD and any additional supporting documents will be provided for the research on the similar topic and can be obtained by asking through the contactperson mention below
From where data/document is obtainable
Contact person; Ilsa Waqi Khunsha Contact no.00923041171975
What processes are involved for a request to access data/document
Ilsawaqikhunsha123@gmail.com
Comments
data is private legacy respect it.
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