Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201804003344186 Date of Approval: 22/04/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title kinesiotaping and coccydynia
Official scientific title Effects of kinesiotaping and exercises on obesity-induced coccydynia : a comparative randomized clinical trial
Brief summary describing the background and objectives of the trial Treatment methods that are easy and cheap without any side effects for the treatment of coccydynia are important to overcome the pain experienced by the majority of patients with obesity. So this study will be conducted to compare the effects of kinesiotaping and exercises in the treatment of coccydynia- induced obesity.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied coccydynia, obesity,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 04/04/2017
Actual trial start date 11/04/2017
Anticipated date of last follow up 14/09/2017
Actual Last follow-up date 21/09/2017
Anticipated target sample size (number of participants) 99
Actual target sample size (number of participants) 90
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
nil known Elsadat Saad Soliman
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using envelope Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group A 3 times per day 3 weeks kinesiotaping and exercise therapy 30
Experimental Group Group B 3 times per day 3 weeks the same exercise therapy 30
Control Group Group c changed every 3 days 3 weeks placebo kinesiotaping 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
coccydynia induced by obesity and their body mass index (BMI) over 32 neurological disorders, bone deficits, skin infections and vascular abnormalities ,rheumatoid arthritis or ankylosing spondylitis 45 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 13/05/2018 Faculty of Physical Therapy,research ethical committee
Ethics Committee Address
Street address City Postal code Country
Faculty of Physical Therapy, Cairo University, 7 Ahmed Elziat Street Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain intensity base line 3 weeks one month later
Secondary Outcome trunk flexion base line 3 weeks one month later
Secondary Outcome functional disability base line 3 weeks one month later
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
physical therapy outpatient clinic centre 7 Ahmed Elziat Street Giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Physical Therapy, Cairo University 7 Ahmed Elziat Street, Ben Elsaryat, El Dokki Giza 12612 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Elsadat Saad Soliman 7 Ahmed Elziat Street, Ben Elsaryat, El Dokki Giza 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Elsadat Saad Soliman 7 Ahmed Elziat Street, Ben Elsaryat, El Dokki Giza 12612 Egypt
Hany M. Elgohary 7 Ahmed Elziat Street, Ben Elsaryat, El Dokki Giza 12612 Egypt
intsar S waked 7 Ahmed Elziat Street, Ben Elsaryat, El Dokki Giza 12612 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hany Hany M. Elgohary gohary75pt@hotmail.com 002010931382291 7 Ahmed Elziat Street, Ben Elsaryat, El Dokki
City Postal code Country Position/Affiliation
Giza 12612 Egypt lecturer of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University
Role Name Email Phone Street address
Public Enquiries Elsadat Soliman sadatsaad@yahoo.com 201129893636 7 Ahmed Elziat Street, Ben Elsaryat, El Dokki
City Postal code Country Position/Affiliation
Giza 12612 Egypt lecturer of Musculoskeletal Disorders and its Surgery, Faculty of Physical Therapy, Cairo University
Role Name Email Phone Street address
Scientific Enquiries intsar waked intsarwaked1976@gmail.com 00966532107885 7 Ahmed Elziat Street, Ben Elsaryat, El Dokki
City Postal code Country Position/Affiliation
Giza 12612 Egypt assisstant professor of Physical Therapy for surgery, Faculty of Physical Therapy, Cairo University
REPORTING
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