Protocol summary
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Study aim
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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.
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Design
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Two parallel group , single blinded, randomized clinical trial with pre and post assessment
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Settings and conduct
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Al-Khumeinie Trust hospital, lahore,
Investigator will be blinded.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Muscle energy technique of (METs) of Piriformis and iliopsoas.
Static stretching of Piriformis and iliopsoas.
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Main outcome variables
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Pain by NPRS
Daily and work-leisure activities, anxiety-depression, and social interest of the patients' lives by Dallas Pain Questionnaire (DPQ)
General information
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Reason for update
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After getting approval, patient recruitment was started so the proposed dates and actual recruitments dates were different.
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Acronym
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EMETSTPIIFC
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IRCT registration information
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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
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Registration date
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2020-01-10, 1398/10/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-11-27, 1398/09/06
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Expected recruitment end date
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2020-02-26, 1398/12/07
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Actual recruitment start date
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2020-01-20, 1398/10/30
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Actual recruitment end date
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2020-04-20, 1399/02/01
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Trial completion date
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2020-04-20, 1399/02/01
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Scientific title
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Effects Of Muscle Energy Technique And Static Stretching Of Piriformis And Iliopsoas In Females With Coccydynia
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Public title
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Effects Of Muscle Energy Technique And Static Stretching Of Piriformis And Iliopsoas In Females With Coccydynia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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1
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Groups that have been masked
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Sample size
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Target sample size:
52
Actual sample size reached:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Investigator will be blind.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-07-16, 1398/04/25
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Ethics committee reference number
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RCR&AHS/REC/MS-OMPT/S19/003
Health conditions studied
1
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Description of health condition studied
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Sacrococcygeal disorders
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ICD-10 code
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M53.3
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ICD-10 code description
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Sacrococcygeal disorders, not elsewhere classified
Primary outcomes
1
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Description
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Pain
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Timepoint
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Pre- Post treatment
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Method of measurement
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Numeric Pain Rating Scale (NPRS)
2
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Description
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Daily and work-leisure activities, anxiety-depression, and social interest of the patients' lives
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Timepoint
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Pre- Post treatment
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Method of measurement
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Dallas Pain Questionnaire (DPQ)
Secondary outcomes
1
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Description
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Pain free sitting duration
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Timepoint
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Pre-Post Treatment
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Method of measurement
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Duration with time watch
Intervention groups
1
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Description
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Intervention group: Muscle energy technique of (METs) of Piriformis and iliopsoas.
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Category
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Treatment - Other
2
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Description
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Intervention group: Static stretching of Piriformis and iliopsoas.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Educational
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Riphah International University
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Proportion provided by this source
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15
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available