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.: PACTR202203839885707 Date of Approval: 07/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of adding ankle stability exercise program to treatment protocol of management of patients with non specific low back pain. Randomized controlled trail
Official scientific title Effects of adding ankle stability exercise program to treatment protocol of management of patients with non specific low back pain. Randomized controlled trail
Brief summary describing the background and objectives of the trial Low back pain (LBP) is a widespread debilitating condition with multiple established etiologies and other causes that remain unknown. In industrialized countries, the rate of low back pain over one’s lifetime is over 70% (Burton et al., 2006). Some past research has looked into lower limb distal problems such as deviations of the foot and ankle. An abnormal gait eventually will interfere with these important spinal segmental movements. This can lead to serial postural distortions, muscular imbalances, and spinal joint dysfunction, along with the previously discussed causes of low back pain (Christensen et al., 2007).
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 Rehabilitation
Anticipated trial start date 31/01/2022
Actual trial start date 01/02/2022
Anticipated date of last follow up 30/06/2022
Actual Last follow-up date 30/06/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Not yet 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 Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group core stabilization exercises program three times \ week for 6week treatment session for 45 minutes three months time frame for the study core stabilization training. 1-Abdominal “Draw In” Maneuver  Aim –To use the correct muscles in response to command “draw in” your abdominal without moving spine or pelvis & hold for 10 sec while breathing normally. To activate Transversus abdominis + lumbar multifidus Patient best position – The 4-point kneeling position is best position to teach the action 2-Activate TrA ms. Flatten lumbar curve. TheraBand and Med ball modifications 30
Control Group ANKLE STABILITY EXRCISES THREE \ WEEK FOR 6 WEEKS 45 MINUTES SESSION 6 MONTHS ANKLE STABILITY TRAINING PROGRAM: 1-Balance board training. 2-resisted exercise for evertors muscles with elastic band. 3-AROM for ankle joint 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) 60 patients with low back pain. 2) The age of patients will range from 20-45 years old. 1) Had acute episode of low back pain. 2) Patients received physical therapy for acute condition in last three months. 3) spinal surgery. 4) complained of any neurological signs. Adult: 19 Year-44 Year 20 Year(s) 45 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 05/12/2021 ETHICAL COMMITTE OF FACULTY OF PHYSICAL THERAPY CAIRO UNIVERSITY
Ethics Committee Address
Street address City Postal code Country
7 AHMED ELZAYYAT STREET CAIRO 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome PAIN INTENSITY USING VAS SCALE BEFORE AND AFTER THE TRETAMNET PROCEDURE
Primary Outcome LUMBAR REGION MOBILITY TEST WITH SAHOUBR TEST BEFORE AND AFTER TREATMENT PROCEDURE
Primary Outcome SPINE FUNCTIONAL LEVEL WITH OSWESTRY QUESTIONER BEFORE AND AFTER TREATMENT PROCEDURE
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FACULTY OF PHYSICAL THERAPY CAIRO UNIVERSITY OUTPATIENT CLINIC. 7 AHMED ELZAYYAT DOKKI Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
MAHMOUD ABDELHALEEM 7 AHMED ELZAYYAT STREET DOKKI Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MAHMOUD ABDELHALEEM 7 AHMED ELZAYYAT STREET CAIRO UNIVERSITY Egypt PRIMARY AUTHOR
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MAHMOUD ABDELHALEEM DR.MAHMOUDDIAB11@GMAIL.COM 01117750496 7 AHMED ELZAYYAT STREET
City Postal code Country Position/Affiliation
DOKKI Egypt LECTURER OF ORTHOPEDIC PHYSICAL THERAPY CAIRO UNIVERSITY.
Role Name Email Phone Street address
Scientific Enquiries EHAB ABDALLAH EABDALLAH@HORUS.EDU.EG 0201223674916 7 AHMED ELZAYYAT STREET
City Postal code Country Position/Affiliation
CAIRO Egypt LECTURER OF ORTHOPEDIC PHYSICAL THERAPY HORUS UNIVERSITY
Role Name Email Phone Street address
Public Enquiries MOHAMED ABDELHAY PROF_DR_PT@YAHOO.COM 01126213339 7 AHMED ELZAYYAT STREET
City Postal code Country Position/Affiliation
CAIRO Egypt Lecturer of Physical Therapy Basic science CAIRO UNIVERSITY
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data IPD will be available. All IPD will be collected during trial and after deidentification. IPD including study protocol, statistical analysis plan, informed consent form, clinical study report and analytic code. All IPD will be available immediately after publication. All IPD will be available to who wishes access to data. Request to access data need to be sent to co-author email (Mahmoud.diab@pt.cu.edu.eg). To gain access, requestors will need to sign a data access agreement. Data will be available for 5 years at a third party website (link to be included). Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol IMMEDIATLY FOLLOWING PUBLICATION, FOR 5 YEARS After finishing the applications, the results will be available and open the data will be quantitative data at VAS, ROM and functions.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not available No
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