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General information
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50
50
empty
2020-01-20, 1398/10/30
2020-01-20 00:00:00
empty
2020-04-20, 1399/02/01
2020-04-20 00:00:00
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2020-04-20, 1399/02/01
2020-04-20 00:00:00
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After getting approval, patient recruitment was started so the proposed dates and actual recruitments dates were different.
After getting approval, patient recruitment was started so the proposed dates and actual recruitments dates were different.
• Pain on palpation at coccyx region.•
Unable to sit pain free.
Pain on palpation at coccyx region.•
Unable to sit pain free.
• Pain on palpation at coccyx region.• Unable to sit pain free.
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: University of South asia, cantt lahore
Name of organization / entity - Persian:
Full name of responsible person - English: Wajeeha
Full name of responsible person - Persian:
Position - English: Senior Lecturer
Position - Persian:
Latest degree: master
Area of specialty/work: 68
Area of specialty/work title - English: Rehabilitation and Research
Area of specialty/work title - Persian:
Street address - English: 47 tufail raod cantt lahore
Street address - Persian:
City - English: Lahore
City - Persian:
Province: punjab
Province - English: punjab
Province - Persian:
contact.provinces_available:
Country: Pakistan
Postal code: 54000
Phone: +92 42 35126110
Mobile: +92 323 4500788
Fax:
Email: wajeeha_z@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: University of South asia, cantt lahore
Name of organization / entity - Persian:
Full name of responsible person - English: Wajeeha
Full name of responsible person - Persian:
Position - English: Assistant professor
Position - Persian:
Latest degree: master
Area of specialty/work: 68
Area of specialty/work title - English: Rehabilitation and Research
Area of specialty/work title - Persian:
Street address - English: 47 tufail raod cantt lahore
Street address - Persian:
City - English: Lahore
City - Persian:
Province: punjab
Province - English: punjab
Province - Persian:
contact.provinces_available:
Country: Pakistan
Postal code: 54000
Phone: +92 42 35126110
Mobile: +92 323 4500788
Fax:
Email: wajeeha_z@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: University of South asia, cantt lahore Name of organization / entity - Persian: Full name of responsible person - English: Wajeeha Full name of responsible person - Persian: Position - English: Senior LecturerAssistant professor Position - Persian: Latest degree: master Area of specialty/work: 68 Area of specialty/work title - English: Rehabilitation and Research Area of specialty/work title - Persian: Street address - English: 47 tufail raod cantt lahore Street address - Persian: City - English: Lahore City - Persian: Province: punjab Province - English: punjab Province - Persian: contact.provinces_available: Country: Pakistan Postal code: 54000 Phone: +92 42 35126110 Mobile: +92 323 4500788 Fax: Email: wajeeha_z@yahoo.com Web page address:
Protocol summary
Study aim
To find the effects of muscle energy technique and static stretching of piriformis and iliopsoas in reducing pain and improvement in pain free sitting in patients with coccydynia.
Design
Two parallel group , single blinded, randomized clinical trial with pre and post assessment
Settings and conduct
Al-Khumeinie Trust hospital, lahore,
Investigator will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria
• Age group of 18 to 40 years
• Pain on palpation at coccyx region.
• Unable to sit pain free.
Exclusion criteria
• Pregnancy
• History of recent trauma/fall or fracture
• Vaginitis, cystitis, salpinities. Urinary tract infections,
• Red flags like: fever, night sweats, malaise etc.
• Rectal abscess
• Patients with cysts or tumor in lumber area and pelvic
• Previous surgical interventions involving lumbar spine and pelvic region
Intervention groups
Muscle energy technique of (METs) of Piriformis and iliopsoas.
Static stretching of Piriformis and iliopsoas.
Main outcome variables
Pain by NPRS
Daily and work-leisure activities, anxiety-depression, and social interest of the patients' lives by Dallas Pain Questionnaire (DPQ)
General information
Reason for update
After getting approval, patient recruitment was started so the proposed dates and actual recruitments dates were different.
Acronym
EMETSTPIIFC
IRCT registration information
IRCT registration number:IRCT20191117045462N1
Registration date:2020-01-10, 1398/10/20
Registration timing:prospective
Last update:2020-11-18, 1399/08/28
Update count:1
Registration date
2020-01-10, 1398/10/20
Registrant information
Name
Wajeeha Zia
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 42 35126110
Email address
wajeeha_z@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-27, 1398/09/06
Expected recruitment end date
2020-02-26, 1398/12/07
Actual recruitment start date
2020-01-20, 1398/10/30
Actual recruitment end date
2020-04-20, 1399/02/01
Trial completion date
2020-04-20, 1399/02/01
Scientific title
Effects Of Muscle Energy Technique And Static Stretching Of Piriformis And Iliopsoas In Females With Coccydynia
Public title
Effects Of Muscle Energy Technique And Static Stretching Of Piriformis And Iliopsoas In Females With Coccydynia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pain on palpation at coccyx region.•
Unable to sit pain free.
Exclusion criteria:
Pregnancy
History of recent trauma/fall or fracture•
Vaginitis, cystitis, salpinities. Urinary tract infections,
Red flags like: fever, night sweats, malaise etc
Rectal abscess•
Patients with cysts or tumor in lumber area and pelvic•
Previous surgical interventions involving lumbar spine and pelvic region
Age
From 18 years old to 40 years old
Gender
Female
Phase
1
Groups that have been masked
Investigator
Sample size
Target sample size:
52
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be recruited in the study through convenient sampling technique and then will be randomly assigned to each group according to consort guideline 2010. Written informed consent will be taken. After enrollment into study, patient will be allocated either to group A or Group B by lottery method. No. of Chits will be equal to total sample size, odd Numbers will be allocated to Group A and even number will be allocated to Group B. Each patients will be requested to draw a chit from the box and after that patient will be recruited into either Group A or Group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
Investigator will be blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Riphah college of rehabilitation & Allied Health Sciences
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Postal code
54000
Approval date
2019-07-16, 1398/04/25
Ethics committee reference number
RCR&AHS/REC/MS-OMPT/S19/003
Health conditions studied
1
Description of health condition studied
Sacrococcygeal disorders
ICD-10 code
M53.3
ICD-10 code description
Sacrococcygeal disorders, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
Pre- Post treatment
Method of measurement
Numeric Pain Rating Scale (NPRS)
2
Description
Daily and work-leisure activities, anxiety-depression, and social interest of the patients' lives
Timepoint
Pre- Post treatment
Method of measurement
Dallas Pain Questionnaire (DPQ)
Secondary outcomes
1
Description
Pain free sitting duration
Timepoint
Pre-Post Treatment
Method of measurement
Duration with time watch
Intervention groups
1
Description
Intervention group: Muscle energy technique of (METs) of Piriformis and iliopsoas.
Category
Treatment - Other
2
Description
Intervention group: Static stretching of Piriformis and iliopsoas.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Riphah college of rehabilitation & Allied Health Sciences
Full name of responsible person
Wajeeha
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Street address
28-M,Quaid-e Azam, Industrial Estate kot Lakhpat, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com
Grant name
Educational
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
Proportion provided by this source
15
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
University of South Asia
Full name of responsible person
Wajeeha
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
47 tufail road cantt lahore
City
Lahore
Province
punjab
Postal code
54000
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation and research
Street address
28-M,Quaid-e Azam, Industrial Estate kot Lakhpat, Lahore
City
Lahore
Province
punjab
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of South asia, cantt lahore
Full name of responsible person
Wajeeha
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
47 tufail raod cantt lahore
City
Lahore
Province
punjab
Postal code
54000
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.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
There is no further information
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