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.: PACTR201608001655272 Date of Approval: 28/05/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Pilates mat exercises versus stabilization exercises for treatment of nonspecific acute low back pain
Official scientific title Pilates mat exercises versus stabilization exercises for treatment of nonspecific acute low back pain
Brief summary describing the background and objectives of the trial It is randomized control trial in which patients are divided into two groups and treated by two different types of exercises in cases of nonspecific acute low back pain. objective of the trial to know which type of exercises are superior than the other in treatment of theses cases.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,nonspecific acute low back pain,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 14/07/2015
Actual trial start date 04/04/2016
Anticipated date of last follow up 28/05/2016
Actual Last follow-up date 28/09/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Recruiting
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 permuted block randomisation random number generator Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pilates mat exercises 3 sessions per week one month 30
Experimental Group Stabilization exercises 3 sessions per week one month 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Sixty female and male patients diagnosed as nonspecific acute low back pain. - Age ranges between 20-40 years (Casazza, 2012). - Symptoms of pain or stiffness in the lower back without lower limb symptoms up to 6 weeks (defined as acute) (Casazza,2012). - Average pain score in the past week is ¿ 4 on an 11 point numeric rating scale (0=no pain and 10= worst pain possible) (Wajswelner et al., 2012). - Their BMI ranged from 25-29.9. - Physiotherapist Colleagues. -No previous spinal surgeries or diagnosed osteoporosis (Amit et al., 2013). -No previous participation in a Pilates program or trunk stabilization exercise program in the last six months (O'Brien, 2010). -No lower limb injuries (Wajswelner et al., 2012). 20 Year(s) 40 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
Yes 14/07/2015 Cairo University
Ethics Committee Address
Street address City Postal code Country
Giza Cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain at the beginning of the study (before treatment). at the end of the study (after treatment).
Primary Outcome lumbar range of motion before treatment after treatment
Primary Outcome function before treatment after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Oct 6th University Clinic 6th October Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Oct 6th University 6th october cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor physical therapy faculty, cairo university Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Prof. Dr. Lilian Albert Zaky 20 Nagaty Serag street, Eight district, Nasr City cairo 11311 Egypt
Prof. Dr. Alaa Eldin Mohyee Suliman 71 Gamet aldewal alarabia street,Mohandeseen cairo 11311 Egypt
Dr. Ghada Mohamed Rashad Koura 68 khatam al morsalin street- al haram cairo 11311 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rabab Afifi rababafifi@ymail.com 00201020370080 177 Al Ashgar Compound Al Wahat Road 6th October
City Postal code Country Position/Affiliation
Cairo 11311 Egypt Lecturer assistant at Physical Therapy Faculty 6th October Univ
Role Name Email Phone Street address
Public Enquiries Emad Mohamed emad9111@live.com 01146808839 187 abdelmonem reyad street- al tahrir
City Postal code Country Position/Affiliation
Cairo 11311 Egypt Physical therapist
Role Name Email Phone Street address
Scientific Enquiries Emad Mohsen emad_pt@outlook.com 01028799322 143 second district 6th october
City Postal code Country Position/Affiliation
Cairo 11311 Egypt Physical therapist
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