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.: PACTR201809481612827 Date of Approval: 11/09/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of core stabilization and dynamic strengthening exercises on pain-related disability and selected cardiopulmonary parameters in patients with non-specific chronic low back pain
Official scientific title Efficacy of core stabilization and dynamic strengthening exercises on pain-related disability and selected cardiopulmonary parameters in patients with non-specific chronic low back pain
Brief summary describing the background and objectives of the trial The trial is designed to determine the efficacy of core stabilization and dynamic strengthening exercises on pain-related disability and selected cardiopulmonary parameters in patients with non-specific chronic low back pain
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 25/06/2018
Actual trial start date 01/06/2018
Anticipated date of last follow up 25/06/2019
Actual Last follow-up date 10/09/2018
Anticipated target sample size (number of participants) 28
Actual target sample size (number of participants) 20
Recruitment status Completed
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Dynamic strengthening exercises 3 times daily 4 weeks Dynamic strengthening exercises strengthens the spinal columnand supporting structures 9 Active-Treatment of Control Group
Experimental Group Core stabilizatio exercise 3 times daily 4 weeks Core Stabilization exercise is a common and active form of exercise prescribed to individuals with low back pain or to other patients with the aim of relieving pain,improving quality of life, strengthening. Abdominals and supporting the spine. 11
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants referred to physiotherapy outpatient's clinic with diagnosis of non-specific chronic low back pain with and without pain radiating to one or both lower limbs. Participant who have history of cardiopulmonary problems prior non-specific chronic low back pain such as asthma, heart disease, chronic obstructive pulmonary disease. Participant who have history of orthopaedics problem including condition of the back that would have affected their abilities to sustain core stabilization exercise. Participant with cognitive limitation Participant with medicalor surgical conditions which may hinder exercise performance. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 65 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 25/06/2018 Lagos University Teaching Hospital Health Research Committee
Ethics Committee Address
Street address City Postal code Country
Room 107, 1st Floor, Lagos University Teaching Hospital Administrative Block, idi-Araba Lagos Lagos 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain, disability Baseline, 4th week and 8th week
Secondary Outcome Kinesiophobia, systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, forced vital capacity, peak expiratory flow rate and forced expiratory volume. Baseline, 4th week and 8th week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital Idi-araba Lagos Nigeria
National Orthopaedics Hospital Igbobi Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mr and Mrs Onwuazombe Block 589, Abesan Housing Estate, Ipaja, Lagos Lagos Nigeria Parents
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Judith Oluchi judehith@gmail.com +2348186080478 Block 589, Flat 6, Abesan Housing Estate, Ipaja Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Student
Role Name Email Phone Street address
Public Enquiries Judith Oluchi judehith@gmail.com +2348186080478 Block 589, Flat 6, Abesan Housing Estate, Ipaja Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Student
Role Name Email Phone Street address
Scientific Enquiries Ashiyat Kehinde akoduashiyat@gmail.com +2348034269053 Idi-Araba
City Postal code Country Position/Affiliation
Lagos Nigeria Physiotherapist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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