Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201605001634379 Date of Approval: 17/05/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title kinesio taping & scoliosis
Official scientific title effect of therapeutic exercises augmented by kinesio taping in treatment of scoliosis in adolescent females
Brief summary describing the background and objectives of the trial scoliosis is lateral sideway curve of the spine usually develop in adolescent females at age 11 to 13 years. it may lead to chronic back pain affect make ventilatory restriction and the subsequent impairment of health related quality of life Objectives of the study :to investigate the effect of therapeutic exercises augmented by kinesio tap in treatment of scoliosis in adolescent females
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 15/05/2016
Actual trial start date 20/05/2016
Anticipated date of last follow up 30/11/2016
Actual Last follow-up date 30/11/2016
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
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 Sealed opaque envelopes Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group group B 3 sessions per week 6 weeks Patients only in group B received kinesio taping techniques. With patient standing and leaning forward to perform maximum flexion of the spine, Alcohol was used to clean skin prior to tape application as skin should be free of oils and lotions then application of kinesio taping techniques. "I" strip for Para spinal muscles: Each patient was asked to flex her back and then the therapist applied the 20 Active-Treatment of Control Group
Experimental Group group B 3 sessions per week 6 weeks Both group instructed to perform therapeutic exercise begin in form of stretching exercise to concave side and strengthening exercise for convex side from supine, side and prone lying position 3 sessions per week for 6 weeks. Patients only in group B received kinesio taping techniques. With patient standing and leaning forward to perform maximum flexion of the spine, Alcohol was used to clean sk 20 Active-Treatment of Control Group
Control Group group (A) 3 session per week 6 weeks instructed to perform therapeutic exercise begin in form of stretching exercise to concave side and strengthening exercise for convex side from supine, side and prone lying position 3 sessions per week for 6 weeks. 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
females their ages ranged from 11 to 17 years old, their BMI was from 25 to 35 kg/m² have-not cardiovascular disorder They are free from diabetes, no hypertension and no history of neurological and haven't leg length discrepancy disorder. 11 Year(s) 17 Year(s) Female
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
Yes 10/05/2016 faculty of physical therapy ethical committeee
Ethics Committee Address
Street address City Postal code Country
Elgesh street kafr elsheikh 53221 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome present pain intensity scale it is graphic rating scale with numerical values placed along line the descriptors and numbers help the subject to estimate on line in which 0 mean no pain 1 mild pain 2 moderate pain 3 sever pain 4 unbearable pain
Secondary Outcome Cobb¿s angle. X ray plain to measuring of Cobb¿s angle.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic of kaferelshiek university Elgesh street kafr el sheikh 53115 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
kafr elshiekh university el gash street kafr el sheikh 533321 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy el gash street kafr el sheikh 511132 Egypt University
COLLABORATORS
Name Street address City Postal code Country
eman abd elfatah elhosary sidi salm kafereishiek 533311 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator eman elhosary emanabdelfatah123@yahoo.com 01276754277 sidi salm
City Postal code Country Position/Affiliation
kafr elshiekh - Egypt lecturer of women health - faculty of physical therapy - kafr elshiekh university
Role Name Email Phone Street address
Public Enquiries handi hamed hanihamed123@yahoo.com - sidi salm
City Postal code Country Position/Affiliation
kafr elshiekh - Egypt lecturer of women health - faculty of physical therapy - kafr elshiekh university
Role Name Email Phone Street address
Scientific Enquiries eman elhosary emanabdelfatah123@yahoo.com 01276754277 sidi salm
City Postal code Country Position/Affiliation
kaferelshiek - Egypt lecturer of women health - faculty of physical therapy - kafr elshiekh university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information