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.: PACTR202309770549011 Date of Approval: 21/09/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of cognitive perception training versus lumbar stabilization exercises in management of subjects with nonspecific low back pain. (Randomized clinical trial)
Official scientific title The effect of cognitive perception training versus lumbar stabilization exercises in management of subjects with nonspecific low back pain. (Randomized clinical trial)
Brief summary describing the background and objectives of the trial Non-specific low-back pain (NSLBP) is defined as the presence of pain in the region below the costal margin and above the lower gluteal folds. It can present with or without lower extremity pain that is not attributable to a specific recognizable cause (Bardin et al., 2017; Iizuka et al., 2017). In recent decades, the biopsychosocial model has been applied as a framework for understanding the complexity of low back pain disability in preference to a purely biomedical approach (Hartvigsen et al., 2018). Many factors including biophysical, psychological, social, and genetic factors, and comorbidities can contribute to disabling low back pain (Hartvigsen 2018; Nicholas et al., 2011). Furthermore, the disability and persistence of pain in patients with chronic low back pain can be partly explained by psychosocial factors such as cognitive factors (Nieminen et al., 2021). Cognitive factors have been described as modulators of the pain experience, favoring the development of chronic pain and disability (Wertli et al., 2014). So the purpose of this study is to the effect of cognitive perception training versus lumbar stabilization exercises in management of subjects with nonspecific low back pain.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/10/2023
Actual trial start date 01/10/2023
Anticipated date of last follow up 01/01/2024
Actual Last follow-up date 01/02/2024
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
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 Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group cognitive perception training patients will receive cognitive perception training and pain control education for Participants attended 90-minute group sessions. frequency : 3 treatments session over 8 weeks Study treatment will be conducted for 6 to 8 weeks for each patient and for 6 months for total study time frame. Cognitive-Behavioral Therapy (CBT) The CBT treatment manual used in this study is adapted from a published and empirically validated. treatment protocol developed by the principal investigator. Participants were provided information. about chronic pain and instructed in skills for pain management. Among the skills discussed and demonstrated, participants learned about behavioral pacing, assertiveness, cognitive restructuring, and relaxation. 60
Control Group traditional physical therapy treatment. Patient will receive treatment for 3o minutes. 3 sessions per week for 10 weeks study time frame will be 6 months. patient will receive shame physical therapy. 60 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Both gender 2-Patient who suffers from chronic low back pain for at least 3 months. 3-Patient with age range between 20-45 years old 1-Patients with acute low back pain for less than 2 weeks. 2-Patients with neurological disorders as peripheral neuropathy. 3-Patients with any back surgeries. 4-Patients with Medical health problems as DM and HTN. Adult: 19 Year-44 Year 19 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 18/07/2023 RESEACH ETHICAL COMMITTE AT FACULTY OF PHYSICAL THERAPY CAIRO UNIVERSITY.
Ethics Committee Address
Street address City Postal code Country
7 AHMED ELZAYYAT STREET GIZA 1124 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Oswestry dysfunction index for functional performance BEFORE AND AFTER TREATMNET AFTER 10 WEEKS
Primary Outcome the Fear-Avoidance Beliefs Questionnaire (FABQ) for cognitive perception of pain BEFORE AND AFTER TREATMENT FOR 10 WEEKS
Secondary Outcome VAS (Visual Analogue Scale) for pain BEFORE AND AFTER TREATMENT 10 WEEKS
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FACULTY OF PHYSICAL THERAPY CAIRO UNIVERSITY 7 AHMED ELZAYYAT STREET GIZA 1124 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SELF FUNDED 7 AHMED ELZAYYAT STREET GIZA 1124 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MAHMOUD DIAB 7 AHMED ELZZAYT GIZA 1134 Egypt Individual
Secondary Sponsor EHAB ABDALAAH 7 AHMED ELZAYYAT STREET GIZA 1124 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator EHAB ABDALLA EABDALLAH@HORUS.EDU.EG 201223674916 7 AHMED ELZAYYAT ST
City Postal code Country Position/Affiliation
GIZA 1124 Egypt Lecturer orthopedic physical therapy at Horus University.
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Diab mahmoud.diab@pt.cu.edu.eg 01117750496 7 AHMED ELZAYYAT
City Postal code Country Position/Affiliation
GIZA 1124 Egypt LECTRURE OF ORTHOPEIDC PHYSICAL THERAPY CAIRO UNIVERSITY
Role Name Email Phone Street address
Public Enquiries EMAN MOHAMED EMAN_PY88@YAHOO.COM 3474596239 7 AHMED ELZAYYAT
City Postal code Country Position/Affiliation
GIZA 1124 Egypt PHD 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. IT WILL BE AVIABLE FOR 5 YEARS. 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).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not avaible 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